Preformed crowns for decayed primary molar teeth

Nicola PT Innes; David Ricketts; Lee Yee Chong; Alexander J Keightley; Thomas Lamont; Ruth M Santamaria

doi:10.1002/14651858.CD005512.pub3

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Figure 1

Study flow diagram

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Analysis 1.1

Comparison 1 Crown versus filling, Outcome 1 Major failure.

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Analysis 1.2

Comparison 1 Crown versus filling, Outcome 2 Pain.

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Analysis 1.3

Comparison 1 Crown versus filling, Outcome 3 Discomfort associated with the procedure.

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Analysis 1.4

Comparison 1 Crown versus filling, Outcome 4 Gingival bleeding.

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Analysis 2.1

Comparison 2 Crown versus non‐restorative caries treatment, Outcome 1 Major failure.

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Analysis 2.2

Comparison 2 Crown versus non‐restorative caries treatment, Outcome 2 Discomfort associated with the procedure.

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Analysis 2.3

Comparison 2 Crown versus non‐restorative caries treatment, Outcome 3 Gingival bleeding.

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Analysis 3.1

Comparison 3 Stainless steel crown vs aesthetic crown, Outcome 1 Gingival bleeding.

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Analysis 3.2

Comparison 3 Stainless steel crown vs aesthetic crown, Outcome 2 Bone resorption.

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Summary of findings for the main comparison. Preformed crowns compared to fillings for decayed primary molar teeth

Preformed crowns compared to fillings for decayed primary molar teeth
Patient or population: decayed primary molar teeth Settings: secondary care, UK and Germany Intervention: preformed crown Comparison: filling
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Filling	Preformed crown
Major failure ‐ long term (12 months to 48 months)	Study population		RR 0.18 (0.06 to 0.56)	346 (3 RCTs)	⊕⊕⊕⊝ moderate ^1,2
	112 per 1000	20 per 1000 (7 to 63)
Pain ‐ long term (12 months to 24 months)	Study population		RR 0.15 (0.04 to 0.67)	312 (2 RCTs)	⊕⊕⊕⊝ moderate ¹	This was based on patient and/or parent reports
	83 per 1000	12 per 1000 (3 to 56)
Satisfaction with treatment
Discomfort associated with the procedure	Study population		RR 0.56 (0.36 to 0.87)	381 (2 RCTs)	⊕⊕⊕⊝ moderate ¹	This was patient‐reported in one study, and dentist‐reported in another study. Outcomes were recorded using different 5‐point scales, but dichotomised for analyses, with all partients who scored 'moderate' or more severe levels of discomfort considered as having experienced discomfort
	239 per 1000	134 per 1000 (86 to 208)
Gingival bleeding ‐ long term (12 months)	Study population		RR 1.74 (0.99 to 3.06)	195 (2 RCTs)	⊕⊕⊝⊝ low ^1,3
	156 per 1000	272 per 1000 (155 to 478)
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). CI: confidence interval; RR: risk ratio, RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Intervention and comparison look different. Blinding of outcome assessor, patients and the person doing the procedures was not possible. Outcomes have subjective elements. Although pain was not measured using validated tools, there was no further downgrading for this. ² One of the studies only had data from 87% of randomised participants from one country (from a multinational study of three countries); the study is still ongoing at the time of publication. ³ Small sample size; event rates were low. Confidence intervals were wide.

Summary of findings for the main comparison. Preformed crowns compared to fillings for decayed primary molar teeth

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Summary of findings 2. Preformed crowns compared to non‐restorative caries treatment for decayed primary molar teeth

Preformed crowns compared to non‐restorative caries treatment for decayed primary molar teeth
Patient or population: children with decayed primary molar teeth Settings: secondary care, Germany Intervention: preformed crown Comparison: non‐restorative caries treatment
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Non‐restorative caries treatment	Preformed crown
Major failure (12 months)	Study population		RR 0.12 (0.01 to 2.18)	92 (1 RCT)	⊕⊝⊝⊝ very low ^1,2
	83 per 1000	10 per 1000 (1 to 162)
Pain	No evidence available
Satisfaction with treatment	No evidence available
Discomfort associated with the procedure	Study population		RR 1.67 (0.65 to 4.25)	104 (1 RCT)	⊕⊝⊝⊝ very low ^1,2	Data were measured on different 5‐point scales, but dichotomised for analyses, with all patients who scored 'moderate' or more severe levels of discomfort considered as having experienced discomfort
	115 per 1000	193 per 1000 (75 to 490)
Gingival bleeding ‐ long term (12 months)	Study population		RR 1.09 (0.42 to 2.86)	92 (1 RCT)	⊕⊝⊝⊝ very low ^1,2
	146 per 1000	159 per 1000 (61 to 417)
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). CI: Confidence interval; RCT: randomised controlled trial, CI: confidence interval; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ There was a very serious risk of bias for this trial. Blinding was impossible as the intervention and comparison looked different, and the outcome had subjective elements in its assessment. Futhermore only 87% of the data from one country (this was a multinational study with three countries) were available. Although pain was not measured using validated tools, there was no further downgrading for this. The study is still ongoing. ² Very serious imprecision; small sample size; wide confidence intervals.

Summary of findings 2. Preformed crowns compared to non‐restorative caries treatment for decayed primary molar teeth

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Table 1. Sensitivity analysis of Analysis 1.1 (with and without Ateih 2008)

Outcome (Analysis)	With all studies included			Excluding Atieh 2008
Outcome (Analysis)	Studies	Participants	Effect estimate	Studies	Participants	Effect estimate
1.1 Major failure
1.1.1 Short term (less than 12 months)	1	76	Not estimable	Not affected
1.1.2 Long term 12 months or more	3	346	RR 0.18 (CI 0.06 to 0.56)	Not affected
1.2 Pain
1.2.1 Short term (less than 12 months)	1	64	Not estimable	Not affected
1.2.2 Long term (12 months or more)	2	312	RR 0.15 (0.04 to 0.67)	Not affected
1.3. Peri/postoperative discomfort/pain	2	381	RR 0.56 (0.36 to 0.87)	Not affected
1.4 Gingival bleeding
1.4.2 Short term (less than 12 months)	2	226	RR 1.69 (0.61, 4.66)	1	76	5.00 (0.25, 100.80)
1.4.3 Long term (12 months or more)	2	195	1.74 (0.99, 3.06)	1	62	1.50 (0.47, 4.80)

Table 1. Sensitivity analysis of Analysis 1.1 (with and without Ateih 2008)

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Comparison 1. Crown versus filling

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Major failure Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Short term (less than 12 months)	1	76	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 Long term (12 months to 48 months)	3	346	Risk Ratio (M‐H, Random, 95% CI)	0.18 [0.06, 0.56]
2 Pain Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Short term (less than 12 months)	1	64	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Long term (12 months to 24 months)	2	312	Risk Ratio (M‐H, Fixed, 95% CI)	0.15 [0.04, 0.67]
3 Discomfort associated with the procedure Show forest plot	2	381	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.36, 0.87]

4 Gingival bleeding Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Short term (less than 12 months)	2	226	Risk Ratio (M‐H, Fixed, 95% CI)	1.69 [0.61, 4.66]
4.2 Long term (12 months)	2	195	Risk Ratio (M‐H, Fixed, 95% CI)	1.74 [0.99, 3.06]

Comparison 1. Crown versus filling

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Comparison 2. Crown versus non‐restorative caries treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Major failure Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Long term (12 months)	1	92	Risk Ratio (M‐H, Fixed, 95% CI)	0.12 [0.01, 2.18]
2 Discomfort associated with the procedure Show forest plot	1	104	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.65, 4.25]

3 Gingival bleeding Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 Long term (12 months)	1	92	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.42, 2.86]

Comparison 2. Crown versus non‐restorative caries treatment

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Comparison 3. Stainless steel crown vs aesthetic crown

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Gingival bleeding Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Short term (less than 12 months)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Long term (48 months)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Bone resorption Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2.1 Short term (less than 12 months)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Long term (48 months)	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 3. Stainless steel crown vs aesthetic crown

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