Selladores para la prevención de la caries dental en los dientes primarios
Referencias
Referencias de los estudios incluidos en esta revisión
Referencias de los estudios excluidos de esta revisión
Referencias de los estudios en curso
Referencias adicionales
Referencias de otras versiones publicadas de esta revisión
Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Study characteristics | ||
| Methods | Design: RCT with split‐mouth design Number of participants: 67 Setting: children were recruited from 5 primary schools and sealants were placed at the dental clinic of school of dentistry Country: Spain Unit of randomisation: quadrant Unit of analysis: tooth Follow‐up: 12 months Dropout: 11 children (16.41%) | |
| Participants | Number randomised: not mentioned clearly, assumed to be 67 children that met the inclusion criteria Number analysed: 44 children providing data for the primary dentition (176 teeth) Age: mean 7.32 years, SD 0.47 (range 7–8 years) Sex: 27 boys and 29 girls (among 56 present for final follow‐up) Mean dmft score at baseline: dft was 1.16, SD 2.06 Inclusion criteria: children with 4 healthy deciduous second molar teeth that required sealing Exclusion criteria: no information provided Baseline caries risk of participants: not mentioned | |
| Interventions | 4 quadrants in each mouth were randomised to receive 1 of the 4 interventions.
Co‐intervention: none | |
| Outcomes | Study primary outcome
Study secondary outcome
Diagnostic criteria for caries: visual and tactile examination using WHO criteria, 1997 | |
| Notes | Funding: none (additional information provided by the author) Trial register: not registered (additional information provided by the author) Inter‐evaluator consistency: examiners were calibrated and kappa scores were > 0.60. Sample size: not calculated Personal communication: Pilar 2019 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "every child received a different sealing material in each quadrant on a random basis." Comments: additional information provided by the author that computer‐assisted method was used for random sequence generation. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided (information provided in response to request was unclear). |
| Blinding of participants and personnel (performance bias)‐Participants | Low risk | Comment: additional information provided by the author that participants were blinded to the group allocation. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Comment: additional information provided by the author that operators were not blinded. |
| Blinding of outcome assessment (detection bias) | Low risk | Quote: "coloured glasses were worn by clinician to minimize sealant colour differences, guaranteeing a blind examination." |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "11 participants (16.4%) had been lost to follow up because of changing school, illness or absenteeism." Comment: reasons for drop‐out unrelated to treatment. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | Comment: no evidence of any other bias. |
| Study characteristics | ||
| Methods | Design: RCT with split‐mouth design Number of participants: 90 Setting: paediatric dental department of Montpellier hospital Country: France Unit of randomisation: teeth within a tooth pair Unit of analysis: tooth Follow‐up: 24 months Dropout: 5 children (19 teeth), 5.6% | |
| Participants | Number randomised: 90 children (278 teeth) Number analysed: 85 children (255 teeth) Age: range 3–7 years Sex: 49 boys and 41 girls Mean dmft score at baseline: d3ft was 1.63, SD 2.04 and D3MFT was 0.46, SD 0.86 Inclusion criteria: children covered by health insurance, having 1 or 2 pairs of contralateral first or second (or both) primary molars Exclusion criteria: presence of a sealant or a restoration and abnormal development like hypoplasia Baseline caries risk of participants: not reported. However, caries risk of the included children was assessed using AAPD caries risk assessment form. | |
| Interventions | 139 tooth pairs (278 teeth) were randomised into 1 of 2 groups of 139 teeth each.
Co‐intervention: oral hygiene and dietary recommendations were given to all. | |
| Outcomes | Study primary outcomes
Diagnostic criteria for caries: visual and tactile examination. If the explorer caught on the tooth, the surface was coded as decayed. | |
| Notes | Funding: not reported Trial register: registered with Clinical Trials Registry (NCT02896088) Inter‐evaluator consistency: examiner was calibrated. Kappa value was not reported. Sample size: calculated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The random allocation sequence was generated on a computer. The side was randomly allocated at each new inclusion." |
| Allocation concealment (selection bias) | Low risk | Quote: "An envelope was provided to the clinician in charge of the sealant placement." |
| Blinding of participants and personnel (performance bias)‐Participants | High risk | Comment: blinding was not possible as participants could see the material placed and control group had no treatment. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Comment: the operator could not be blinded as sealant was placed on 1 tooth and contralateral tooth served as control. |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "the same operator who placed the sealant conducted all examinations at baseline and follow up." Comment: blinding of outcome assessor could not be performed in such studies. |
| Incomplete outcome data (attrition bias) | Low risk | Comment: all missing data mentioned. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | No other bias found. |
| Study characteristics | ||
| Methods | Design: RCT with parallel design Number of participants: 508 Setting: children recruited from dental planning areas with high levels of caries and sealants were placed in community clinics, health centres and some in patient homes Country: UK Unit of randomisation: child Unit of analysis: child Follow‐up: mean (range): 1.34 years, SD 0.50 (12–30 months) Dropout: 11.6% | |
| Participants | Number randomised: 508 children Number analysed: 449 children Age: mean 2.02 years, SD 0.29 (range 1–3 years) Sex: 251 (49%) boys and 257 (51%) girls Mean dmft score at baseline: d‐0.72, m‐0.49, f‐0.08 Inclusion criteria: children aged 18–30 months, with caries‐free primary first molars, with or without caries elsewhere in the mouth, at high risk of developing caries Exclusion criteria: unerupted primary molars and primary molars with dentinal caries (additional information provided by the author) Baseline caries risk of participants: high caries risk | |
| Interventions | 2 arms
Co‐intervention: standard package of dental health education on feeding and healthy eating was delivered; child‐sized toothbrushes and toothpaste were given for brushing for the participants in both groups. | |
| Outcomes | Study primary outcomes
Study secondary outcome
Diagnostic criteria for caries: visual and tactile using BASCD criteria for caries by Pitts and Evans 1997 | |
| Notes | Funding: NHS Research and Development Programme in Primary Dental Care Trial register: registered (ISRCTN98615437) (additional information provided by the author) Inter‐evaluator consistency: no information provided Sample size: calculated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Children were randomly allocated to active and control groups." Comment: no additional information was provided by the author. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. No additional information provided by the author. |
| Blinding of participants and personnel (performance bias)‐Participants | High risk | Comment: blinding of participants usually not possible in this study design for sealants as they can see the material on tooth. No information provided on 'placebo.' |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Comment: the operator could not be blinded as sealant was placed on 1 tooth and contralateral tooth served as control. |
| Blinding of outcome assessment (detection bias) | High risk | Comment: blinding of outcome assessor could not be performed in such studies. |
| Incomplete outcome data (attrition bias) | Unclear risk | Quote: "The overall dropout rate was 11.6%. At follow up, number of subjects in the test group was 221 (drop out rate 8.3%) and control group was 228 (drop rate 10.6%)." Comment: drop‐out similar in intervention and comparator groups but reasons for attrition not reported. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | Comments: no evidence of other bias. |
| Study characteristics | ||
| Methods | Design: RCT with split‐mouth design Number of participants: 40 Setting: children were recruited from the ones seeking regular dental care from Public Health service Country: Brazil Unit of randomisation: teeth within a tooth pair Unit of analysis: tooth Follow‐up: 12 months Dropout: none | |
| Participants | Number randomised: 40 children; 40 pairs of primary and 40 pairs of permanent teeth (total 160 teeth) Number analysed: 40 children; 160 teeth Age: range 4–7 years Sex: 40% boys and 60% girls (additional information provided by the author) Mean dmft score: no information provided Inclusion criteria: children aged 4–7 years with ≥ 1 homologous pair of intact, caries‐free, fully erupted first or second primary molars or first permanent molars (or both), with deep and retentive pits and fissures Exclusion criteria: children without homologous primary and permanent molars, occlusal caries in molars and children with systemic diseases (additional information provided by the author) Baseline caries risk of participants: no information provided | |
| Interventions | 2 treatment arms
Both materials sealants were placed under isolation with a rubber dam and saliva ejector. The occlusal surfaces were etched with 37% phosphoric acid gel (Gel Etchant, Kerr Corporation, Orange, California, USA) for 30 seconds Co‐intervention: none Diagnostic criteria for caries: visual inspection and bitewing radiograph | |
| Outcomes | Study primary outcome
| |
| Notes | Funding: none (additional information provided by the author) Trial register: not registered (additional information provided by the author) Inter‐evaluator consistency: examiner was calibrated and kappa scores were 0.86 (additional information provided by the author) Sample size: was calculated (additional information provided by the author) Personal communication: Regina 2019 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using a half mouth design, a filled resin based pit and fissure sealant was applied on randomly assigned upper/lower primary and permanent molars on one side of the mouth and a single bottled adhesive system used in association with a flowable resin composite was applied to the contralateral side." Comment: additional information provided by the author that random numbers were generated using Excel. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
| Blinding of participants and personnel (performance bias)‐Participants | Low risk | Comment: additional information provided by the author that participants were blinded to group allocation. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Comment: blinding was not possible as operator could visualise the difference in material. |
| Blinding of outcome assessment (detection bias) | High risk | Comment: blinding of outcome assessor was not possible due to difference in material. |
| Incomplete outcome data (attrition bias) | Low risk | Comments: all participants assessed at follow‐up. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | No evidence of any other bias. |
| Study characteristics | ||
| Methods | Design: double‐blind RCT with split‐mouth design Number of participants: 100 Setting: children were recruited from kindergartens and sealants also placed in kindergarten Country: Guangzhou city, China Unit of randomisation: teeth within a tooth pair Unit of analysis: tooth Follow‐up: 18 months Dropout: 11% | |
| Participants | Number randomised: 100 children (200 teeth pairs) Number analysed: 89 children; 178 teeth pairs (168 teeth in resin‐based sealant group and 188 teeth in GIC sealant group) Age: mean 3 years Sex: no information provided Mean dmft score: no information provided Inclusion criteria: healthy 3‐year‐old children whose parents consented, with deep fossa or enamel caries not involving dentin, with or without radiographic evidence of caries Exclusion criteria: no information provided | |
| Interventions | 2 treatment arms
Both materials sealants were placed under isolation with cotton rolls. There is no mention on etchant used. GIC was mixed in 1:1 ratio, filled in fossa and pressed with a vaseline‐coated gloved forefinger. Co‐intervention: none | |
| Outcomes | Study primary outcomes
Study secondary outcomes
Diagnostic criteria for caries: visual and tactile as per criteria in Oral Health Surveys basic methods 4th edition recommended by WHO 1997, recorded as dmft. | |
| Notes | Funding: no information provided Trial register: no information provided Inter‐evaluator consistency: for dental caries, kappa values were 0.85, 0.82, 0.90 and for sealants were 0.80 and 0.89 Sample size: not calculated There were flaws in reporting the data. There was variation in the number of resin sealants placed in the first and second follow‐up. Number of resin sealants placed is 168 in 6 months' follow‐up and 172 in 18 months' follow‐up. No explanation is found in the results | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Eight left or right unilateral deciduous molar teeth were treated with ART glass ionomer sealant. One week later contralateral deciduous molar teeth were treated with Resin sealant." Comment: no reply to request for information. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
| Blinding of participants and personnel (performance bias)‐Participants | High risk | Comment: no information provided. Comment: we consider it as high risk as GIC sealants and light‐cured resin sealants were placed at 2 separate points in time. Hence, the participants would know. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Comment: same operator performed both ART sealants and resin sealants. Also there would be a difference in the sealant materials. |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "Examiner was blinded." Comment: blinding not possible – assessor could visualise the difference in sealant materials as GIC sealants are more opaque than resin‐based sealants. |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "Children who did not participate in the test twice consecutively due to sick leave or transfer to another school were excluded. Finally 89 children were included with the loss rate of 11%." Comment: dropout not related to treatment. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | Comment: no evidence of any other bias. |
| Study characteristics | ||
| Methods | Design: RCT with bilateral study design Number of participants: 100 Setting: children were recruited from 7 different schools Country: India Unit of randomisation: tooth pair Unit of analysis: group Follow‐up: 24 months Dropout: no dropout | |
| Participants | Number randomised: 100 children; 100 tooth pairs (100 resin‐based sealant group and 100 glass ionomer sealant group) Number analysed: 100 children; 100 teeth pairs Age: range 3–5 years Sex: no information provided Mean dmft score: no information provided Inclusion criteria: teeth erupted < 4 years ago, healthy, non‐hypoplastic, caries‐free second primary molars, with complete intact tooth structure Exclusion criteria: hypoplastic, unhealthy, lost tooth structure | |
| Interventions | 2 treatment arms
Both the sealants were placed under isolation with cotton rolls and suction and also rubber dam wherever feasible. Occlusal surface was etched with 37% phosphoric acid, light‐cured for 20 seconds. GIC was mixed in 1.8:1 ratio, filled in fossa and light cured for 20 seconds. Fuji varnish was applied. Co‐intervention: none | |
| Outcomes | Study primary outcome
| |
| Notes | Funding: no information provided Trial register: no information provided Inter‐evaluator consistency: no information provided Sample size: not calculated Notes: few teeth were isolated using cotton rolls and few teeth with rubber dam. Paired data not considered for analysis. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "A randomized study with bilateral study design was followed in which both sealant materials were applied in the same mouth on contra‐lateral teeth for direct comparison. For each of these patients, Fuji Vii was placed on one side while concise was used on contra lateral tooth." Comment: method of randomisation not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Blinding of participants and personnel (performance bias)‐Participants | High risk | Quote: "Fuji VH (glass ionomer pink sealant, GC Corporation – Tokyo, Japan) was placed on one side while Concise (unfilled white resin sealant, 3M ESPE Dental Products, St.Paul, Minn) was used on the contra‐lateral tooth." Comment: difference in colour of the sealant material would make blinding impossible. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Blinding not possible – operator could visualise the material difference in sealants. |
| Blinding of outcome assessment (detection bias) | High risk | Comment: blinding not possible – assessor could visualise the material difference in sealants. |
| Incomplete outcome data (attrition bias) | Low risk | Comment: all participants assessed at follow‐up. |
| Selective reporting (reporting bias) | High risk | Comment: all prespecified outcomes reported, but a composite outcome of caries incidence and retention was used. The caries information could not be extracted from the composite outcome and was not reported separately, therefore, we were unable to use the caries data from this study. |
| Other bias | Low risk | No evidence of any other bias. |
| Study characteristics | ||
| Methods | Design: RCT with split‐mouth design Number of participants: 52 Setting: children were recruited from paediatric dentistry section, municipal dental clinics around municipality of Arhus Country: Denmark Unit of randomisation: teeth within each tooth pair Unit of analysis: tooth pairs Follow‐up: 2–2.3 years Dropout: 1 pair of teeth | |
| Participants | Number randomised: 52 pairs of teeth in 52 children Number analysed: 51 pairs of teeth Age: mean 3.7 years (range 2.11–4.11 years) Sex: 25 boys and 27 girls Mean dmft score at baseline: not mentioned Inclusion criteria: children with pairs of sound primary molars Exclusion criteria: no information provided Baseline caries risk of participants: no information provided | |
| Interventions | 2 treatment arms
Co‐intervention: none | |
| Outcomes | Study primary outcomes
Diagnostic criteria for caries: caries was diagnosed at cavitation level. | |
| Notes | Funding: no information provided Trial register: no information provided Inter‐evaluator consistency: no information provided Sample size: no information provided | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "The teeth within each tooth pair were randomly assigned to sealing with Delton1 or Prisma‐Shield1." Comment: method of random sequence generation not mentioned. |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided. |
| Blinding of participants and personnel (performance bias)‐Participants | High risk | Comment: no information provided, but difference in material may not allow for blinding of participants. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Quote: "All children were examined by the same dentist, who also placed all the sealants." Comment: blinding of operator not possible as 1 was a light‐cured resin and the other was autopolymerising resin. |
| Blinding of outcome assessment (detection bias) | High risk | Comment: blinding of outcome assessor was not possible due to material difference in sealants. |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "One pair was omitted because the control tooth had been extracted." |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | No evidence of any other bias. |
| Study characteristics | ||
| Methods | Design: hybrid RCT with split‐mouth design (for comparison of retention of different sealant types) Number of participants: 111 Setting: paediatric dental department of a dental college Country: India Unit of randomisation: 2‐stage randomisation. At first, tooth pairs were randomised into study and control groups (sealant vs no sealant). Next, in study group alone, each tooth in a tooth pair was randomised to receive additional light curing or not Unit of analysis: tooth Follow‐up mean: 1 year Dropout: 10 teeth (8 teeth in study group and 2 teeth in control group) | |
| Participants | Number randomised: 180 pairs of primary second molars Number analysed: 175 pairs of primary molars Age: mean 4.19 years (range 3–5 years) Sex: 64 boys and 47 girls Mean dmft score: 8.45 SD 6.4 in study group and 8.35 SD 5.4 in control Inclusion criteria: fully erupted primary teeth with ≥ 1 pair of bilateral maxillary/mandibular caries‐free primary second molars, no history of preventive treatment in preceding 6 months, high risk of developing caries Exclusion criteria: permanent molars, medically compromised, children with physical limitation Baseline caries risk of participants: high caries risk | |
| Interventions | 2 treatment arms
Co‐intervention: demonstration using videos and models for proper tooth brushing; all participants brushed twice daily with low‐fluoride toothpaste in all groups. | |
| Outcomes | Study primary outcome
Study secondary outcomes
Caries diagnostic criteria: visual using ICDAS | |
| Notes | Funding: none (additional information provided by the author) Trial register: registered (CTRI/2017/10/010248) Inter‐evaluator consistency: kappa values were 0.6 for dental caries and 0.7 for sealants Sample size: not calculated Personal communication: Sakshi 2019 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "lottery method, even numbers for the study group and odd numbers for the control group, another round of randomisation was also done by asking the child to pick up the chit with right or left written on it." |
| Allocation concealment (selection bias) | Unclear risk | Comment: additional information provided by the author as allocation concealment done. However, no information provided on how it was done. |
| Blinding of participants and personnel (performance bias)‐Participants | High risk | Comment: children would be aware that they were receiving sealant or no sealant or an additional light‐curing technique. |
| Blinding of participants and personnel (performance bias)‐ Operator | High risk | Comment: additional information provided by the author that operator was not blinded as single operator performed all the intervention. Comment: blinding operator was not possible as 1 required light curing and the other did not. |
| Blinding of outcome assessment (detection bias) | High risk | Quote: "Assessors were blinded." Comment: blinding outcome assessor not possible to compare sealant with no sealant. |
| Incomplete outcome data (attrition bias) | Low risk | Quote: "At the first follow up a total dropout of 8 teeth in study group and 2 teeth in control group was recorded. No further dropouts occurred." Comment: drop‐out low and similar across groups. Reasons for drop‐out due to patient non‐attendance at clinical examination. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes were reported. |
| Other bias | Low risk | No evidence of any other bias. |
| Study characteristics | ||
| Methods | Design: RCT with split‐mouth design Number of participants: 75 Setting: university clinic (additional info provided by the author) Country: Turkey (additional info provided by the author) Unit of randomisation: tooth Unit of analysis: child and tooth surface Follow‐up: 24 months Dropout: no dropouts (additional info provided by the author) | |
| Participants | Number randomised: 75 children, 150 teeth (25 children helioseal + Aegis, 25 children helioseal F + helioseal and 25 children Aegis + helioseal F) Number analysed: 75 children, 150 teeth Age: mean 4.88 years (range 4–7 years) Sex: 36 boys and 39 girls Mean dmft score: no information provided Inclusion criteria: occlusal surfaces of fully erupted teeth with deep and retentive fissures, without pre‐existence of caries, sealants, fillings and developmental defects, in healthy co‐operative children aged 4–7 years Exclusion criteria: no information provided Baseline caries risk: no information provided | |
| Interventions | 3 treatment arms
All materials sealants were placed under isolation with cotton rolls and saliva ejector. There is no mention on etchant used. All were cured with LED curing light. Co‐intervention: all children and parents were informed about satisfactory oral hygiene procedures and dietary advice was also given. | |
| Outcomes | Primary outcomes
Caries diagnostic criteria: visual and tactile | |
| Notes | Funding: none (additional information provided by the author) Trial register: not registered (additional information provided by the author) Inter‐evaluator consistency: examiners were calibrated. Kappa scores were 0.87 for retention, 0.92 for marginal discolouration and 0.92 for marginal adaptation Sample size: calculated (additional information provided by the author) Notes: sealants were placed by different operators who were students Personal communication: Murat 2019 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quotes: "The 75 children were randomly divided into three group (n‐25)." "Aegis and Helioseal were randomly applied in a split mouth design on mandibular second primary molars." Comment: additional information provided by author was unclear. |
| Allocation concealment (selection bias) | Unclear risk | Comment: additional information provided by the author that allocation concealment was done, but no information on how it was done. |
| Blinding of participants and personnel (performance bias)‐Participants | Low risk | Comment: additional information provided by author – participants were blinded. |
| Blinding of participants and personnel (performance bias)‐ Operator | Low risk | Comment: additional information provided by author – operator was blinded. |
| Blinding of outcome assessment (detection bias) | Low risk | Comment: additional information provided by author – assessor was blinded. We classified this as low risk of bias as Helioseal and Helioseal F are similar in appearance and difficult to be differentiated clinically. |
| Incomplete outcome data (attrition bias) | Low risk | Comment: additional information provided by author – no dropouts. |
| Selective reporting (reporting bias) | Low risk | Comment: all prespecified outcomes reported. |
| Other bias | Low risk | No evidence of any other bias. |
AAPD: American Association of Pediatric Dentistry; ART: atraumatic restorative treatment; BASCD: British Association for the Study of Community Dentistry; dft: decayed filled primary teeth; dmft: decayed missing filled primary teeth; DMFT: decayed missing filled permanent teeth; GIC: glass ionomer; ICDAS: International Caries Detection and Assessment System; LED: light‐emitting diode; RCT: randomised controlled trial; SD: standard deviation; World Health Organization.
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
| Not a randomised controlled trial. | |
| Sealant was placed on cavitated caries in dentin on occlusal surface of primary molars. | |
| The study compared sealants with composite restoration on primary teeth on non‐cavitated dentinal caries. | |
| Not a randomised controlled trial. | |
| Not a randomised controlled trial. | |
| Not a randomised controlled trial. Study did not have a control group. | |
| Not a randomised controlled trial. | |
| Flowable resin was used as sealant to seal cavitated dentinal caries. | |
| The study investigated the effects of different etching times on the retention of sealants on primary and permanent molars and did not have a control group. | |
| Not a randomised controlled trial. | |
| Sealant was placed on cavitated caries in dentin on occlusal surface of primary molars. | |
| The study compared sealants with fluoride varnish. | |
| The study compared the effect of fluorine protective paint used with sealant. | |
| Not a randomised controlled trial. | |
| This study compared the effectiveness of different types of etchant on retention of sealants. | |
| This study compared the isolation method on retention of a single fissure sealant. | |
| Not a randomised controlled trial. | |
| Not a randomised controlled trial. | |
| Randomisation was systematic. | |
| Not a randomised controlled trial. | |
| Randomisation was systematic. | |
| Not a randomised controlled trial. Study did not have a control group. | |
| Not a randomised controlled trial. | |
| Not a randomised controlled trial. | |
| Not a randomised controlled trial. The study compared the sealant retention between primary and permanent molars. | |
| This study compared effectiveness of different types of etchant on retention of sealant. |
Characteristics of ongoing studies [ordered by study ID]
| Study name | Four sealing materials combined with self‐etched adhesive system used as pit and fissure |
| Methods | RCT with parallel design, follow‐up 12 months |
| Participants | Health children aged 3–5 years with 4 second deciduous molars with deep fissures or fissure with signs of early caries |
| Interventions | Resin‐based sealant, flowable composite resin, glass‐ionomer cement and glass‐ionomer protective film |
| Outcomes | Survival rate and caries prevention rate |
| Starting date | September 2018 |
| Contact information | Dr Luo Yu, Stomatological Hospital of Kunming Medical University, China |
| Notes |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Incidence of caries at 12 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 1.1  Comparison 1: Resin‐based sealant versus no sealant, Outcome 1: Incidence of caries at 12 months | ||||
| 1.2 Incidence of caries at 24 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 1.2  Comparison 1: Resin‐based sealant versus no sealant, Outcome 2: Incidence of caries at 24 months | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Incidence of caries at different follow‐up Show forest plot | 2 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 2.1  Comparison 2: Glass ionomer‐based sealants versus no sealants, Outcome 1: Incidence of caries at different follow‐up | ||||
| 2.1.1 6‐month follow‐up | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.2 12‐ to 30‐month follow‐up | 2 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Retention of sealants at 24 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 3.1  Comparison 3: Glass ionomer sealants versus resin‐based sealants, Outcome 1: Retention of sealants at 24 months | ||||
| 3.1.1 24 months | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Incidence of caries at 24–36 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 4.1  Comparison 4: Autopolymerised sealant versus light polymerised sealant, Outcome 1: Incidence of caries at 24–36 months | ||||
| 4.2 Retention of sealants at 24–36 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Analysis 4.2  Comparison 4: Autopolymerised sealant versus light polymerised sealant, Outcome 2: Retention of sealants at 24–36 months | ||||
Aetiopathogenesis of pit and fissure caries.
Classification of sealants.
Flow of studies in the review.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Comparison 1: Resin‐based sealant versus no sealant, Outcome 1: Incidence of caries at 12 months
Comparison 1: Resin‐based sealant versus no sealant, Outcome 2: Incidence of caries at 24 months
Comparison 2: Glass ionomer‐based sealants versus no sealants, Outcome 1: Incidence of caries at different follow‐up
Comparison 3: Glass ionomer sealants versus resin‐based sealants, Outcome 1: Retention of sealants at 24 months
Comparison 4: Autopolymerised sealant versus light polymerised sealant, Outcome 1: Incidence of caries at 24–36 months
Comparison 4: Autopolymerised sealant versus light polymerised sealant, Outcome 2: Retention of sealants at 24–36 months
| Fluoride‐releasing resin‐based sealants versus no sealants | |||||
| Population: children with caries‐free (or non‐cavitated carious lesion) primary molars, aged 3–7 years Settings: paediatric department, dental hospital (France) Intervention: fluoride‐releasing resin‐based sealant Comparison: no treatment | |||||
| Outcome | Anticipated absolute effects (95% CI) | Relative effect (95% CI) | No of participants | Certainty of the evidence | |
|---|---|---|---|---|---|
| Risk with no sealant | Risk with resin‐based sealant | ||||
| Development of ≥ 1 new carious lesion (caries incidence) Follow‐up: 12 months | 36 per 1000 | 44 per 1000a (14 to 130) | BB OR 1.21 (0.37 to 3.94) | 88 children, 274 teeth (1 RCT) | ⨁⨁◯◯ |
| Development of ≥ 1 new carious lesion (caries incidence) Follow‐up: 24 months | 205 per 1000 | 164 per 1000c (95 to 268) | BB OR 0.76 (0.41 to 1.42) | 85 children, 255 teeth (1 RCT) | ⨁⨁◯◯ |
| Progression of non‐cavitated enamel caries | No studies reported this outcome. | ||||
| Adverse events | No studies reported this outcome. | ||||
| *The basis for the assumed risk is the control group risk in the study. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence | |||||
| aAt 12 months, sealants on 96 (70.1%) teeth were completely retained, 25 (18.3%) were partially retained and 16 (11.65%) were completely lost. | |||||
| Glass ionomer‐based sealants versus no sealants | ||||||
| Population: children with caries‐free primary first molars with or without caries affecting other teeth, aged 1–5 years Settings: paediatric clinic, dental school (India) and community dental setting (UK) Intervention: glass ionomer‐based sealants Comparison: no sealants | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Risk with no sealants | Risk with GIC sealants | |||||
| Development of at ≥ 1 new carious lesion (caries incidence) Follow‐up: 12–30 months | 235 per 1000 | 229 per 1000 (162 to 314)a | OR 0.97 (0.63 to 1.49) | 449 (1 RCT) | ⊕⊕⊝⊝ | The evidence for this comparison is equivocal. In an additional trial randomising 107 children, the odds of developing a new carious lesion at 6‐ and 12‐month follow‐up were lower for the sealant group than the no‐sealant group at both time points (6 months: OR 0.031, 95% CI 0.002 to 0.601; 12 months: OR 0.033, 95% CI 0.007 to 0.149).c |
| Progression of non‐cavitated enamel caries | No studies reported this outcome. | |||||
| Adverse events | No studies reported this outcome. | |||||
| *The basis for the assumed risk is the control group risk in the study. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aOne or more sealants in 69 (31.2%) children were fully or partially retained at follow‐up. | ||||||
| Glass ionomer‐based sealants versus resin‐based sealants | ||||||
| Population: 'healthy' children, with caries‐free second primary molars, aged 3–5 years Settings: schools and kindergarten, India and China Intervention: glass ionomer‐based sealants Comparison: fluoride‐releasing or non‐fluoride‐releasing resin‐based sealants | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Risk with resin‐based sealants | Risk with glass ionomer‐based sealants | |||||
| Development of ≥ 1 new carious lesion (caries incidence) Follow‐up: 6–24 months | N/A Insufficient quantitative information available | N/A | 200 (2 studies) | ⊕⊝⊝⊝ | Due to the methods of data collection, analysis and reporting we were unable to provide any quantitative estimates for this comparison. | |
| Progression of non‐cavitated enamel caries | No studies reported this outcome. | |||||
| Sealant retention Complete or partial retention of sealant Follow‐up: 24 monthsb | 70 per 1000 | 320 per 1000 (208 to 458) | BB OR 0.20 (0.11 to 0.36) | 100 children, 100 tooth pairs (1 RCT) | ⊕⊝⊝⊝ Very lowa | We were unable to re‐analyse the results from an additional split‐mouth study (several tooth pairs) that failed to consider the split‐mouth nature of the data and the multiple teeth treated. The authors reported that, "At 6 month after pit and fissure seal, detachment rate was lower in the glass ionomer group compared with resin group (P = 0). At 18 months, detachment rate was lower in the glass ionomer group compared with resin group (P = 0.113)." |
| Adverse events | — | — | — | 100 children (1 RCT) | ⊕⊝⊝⊝ Very lowa | 1 study reported adverse events as some discomfort such as nausea among some children. 1 child reported feeling uncomfortable and experienced a strong gag reflex following application of the glass ionomer‐based sealant while 8 children reported feeling uncomfortable after the fluoride resin‐based applications. |
| *The basis for the assumed risk is the control group risk. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded two levels for study limitations arising from lack of blinding and selective reporting, and one level for imprecision. | ||||||
| Fluoride‐releasing resin‐based sealants versus resin‐based sealants | ||||||
| Population: children with caries‐free second primary molars, aged 4–8 years Settings: dental clinic, Turkey and Spain Intervention: fluoride‐releasing resin‐based sealants Comparison: resin‐based sealants | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Risk with fluoride‐releasing resin‐based sealants | Risk with resin‐based sealants | |||||
| Development of ≥ 1 new carious lesion (caries incidence) Follow‐up: 6–24 months | N/A insufficient quantitative information available | N/A | 69 (2 studies) | ⊕⊕⊝⊝ | Due to the different sealant materials evaluated, data reporting (split‐mouth studies reported as parallel‐group studies) and the very low number of tooth surfaces developing new carious lesions, we were unable to pool these data in a meta‐analysis. | |
| Progression of non‐cavitated enamel caries | No studies reported this outcome. | |||||
| Sealant retention Complete or partial retention of sealant Follow‐up: 6–24 months | — | — | Effect estimate not calculable | 69 (2 studies) | ⊕⊝⊝⊝ Very lowb | Due to the different sealant materials evaluated, data reporting (split‐mouth studies reported as parallel‐group studies) and the very low number of sealants that were lost, we were unable to pool these data in a meta‐analysis. |
| Adverse events | No studies reported this outcome. | |||||
| *The basis for the assumed risk is the control group risk. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; N/A: not applicable. | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe judged the certainty of the evidence to be low for this comparison, and downgraded two levels for imprecision owing to the small study sample sizes and very low numbers of events. | ||||||
| Flowable resin composite versus resin‐based sealants | ||||||
| Population: children who were regular dental attenders with caries‐free first or second primary molars Settings: Public Health service clinic in Brazil Intervention: flowable resin composite Comparison: resin‐based sealants | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Assumed risk | Corresponding risk | |||||
| Risk with resin‐based sealants | Risk with flowable resin composite | |||||
| Development of ≥ 1 new carious lesion (caries incidence) | No studies reported this outcome. | |||||
| Progression of non‐cavitated enamel caries | No studies reported this outcome. | |||||
| Sealant retention Complete or partial retention of sealant Follow‐up: 12 months | — | — | Effect estimate not calculable. All sealants were completely or partially retained. | 40 (1 RCT) | ⨁⨁◯◯ | All sealants were retained or partially retained in both groups. |
| Adverse events | No studies reported this outcome. | |||||
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aWe downgraded the evidence two levels due to study limitations arising from lack of blinding and imprecision from a single study with a small number of participants with no failures. | ||||||
| Autopolymerised sealant versus light polymerised sealant | |||||
| Population: children with sound primary molars, aged 2–4 years Settings: municipal dental clinics or hospital paediatric clinics, Denmark Intervention: autopolymerised sealant application Comparison: light polymerised sealant application | |||||
| Outcome | Anticipated absolute effects (95% CI) | Relative effect (95% CI) | No of participants | Certainty of the evidence | |
|---|---|---|---|---|---|
| Risk with light polymerised sealant | Risk with autopolymerised sealant | ||||
| Development of ≥ 1 new carious lesion (caries incidence) Follow‐up: 24–36 months | 98 per 1000 | 59 per 1000 (16 to 192) | OR 0.58 (0.15 to 2.19) | 52 children, 52 tooth pairs (1 RCT) | ⊕⊝⊝⊝ |
| Progression of non‐cavitated enamel caries | No studies reported on this outcome. | ||||
| Sealant retention Complete or partial retention of sealant Follow‐up: 24–36 months | 904 per 1000 | 865 per 1000 (756 to 931) | OR 0.68 (0.33 to 1.44) | 52 children, 52 tooth pairs (1 RCT) | ⊕⊝⊝⊝ |
| Adverse events | No studies reported this outcome. | ||||
| *The basis for the assumed risk is the control group risk. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | |||||
| GRADE Working Group grades of evidence | |||||
| aWe downgraded the evidence three levels to very low due to study limitations arising from lack of blinding, imprecision from a single study and indirectness of comparator sealant. | |||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Incidence of caries at 12 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 1.2 Incidence of caries at 24 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Incidence of caries at different follow‐up Show forest plot | 2 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.1 6‐month follow‐up | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 2.1.2 12‐ to 30‐month follow‐up | 2 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Retention of sealants at 24 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 3.1.1 24 months | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 4.1 Incidence of caries at 24–36 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
| 4.2 Retention of sealants at 24–36 months Show forest plot | 1 | Odds Ratio (IV, Fixed, 95% CI) | Totals not selected | |
