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Cochrane Database of Systematic Reviews Protocol - Intervention

Interventions for treating denture stomatitis

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the efficacy and effectiveness of interventions (which may be placebo) to treat denture stomatitis.

The following primary null hypothesis will be tested for comparison between groups receiving or not active treatment against denture stomatitis:

  • There is no difference between active treatment or placebo for the treatment of stomatitis caused by dentures.

Background

Lesions of the oral mucosa associated with the wearing of removable dentures may represent acute or chronic reactions to microbial denture plaque, a reaction to constituents of the denture base material, or a mechanical denture injury. These lesions constitute a heterogeneous group with regard to pathogenesis (Budtz‐Jorgensen 1981). They include stomatitis caused by dentures, angular cheilitis, traumatic ulcers, denture irritation hyperplasia, flabby ridges, and oral carcinomas (Budtz‐Jorgensen 1981).

Stomatitis caused by dentures is also termed as denture‐induced stomatitis, denture stomatitis and denture‐related stomatitis in the literature. It is the term used in the literature to indicate an inflammatory state of the denture bearing mucosa (Lombardi 1993). It is a pathology that is characterized by chronic erythema and oedema of part or all of the palatal mucosa under maxillary dentures (Cross 1998). It is the most common alteration on the palate of denture wearers (Pires 2002) and it affects particularly elderly people (Lombardi 1993). It was first graded by Newton according to the severity of its clinical appearance in: localized erythematous (or type I), diffuse erythematous (type II) and hyperplastic granular (type III) (Newton 1962).

Denture stomatitis is considered a multifactorial disease precipitated by several predisposing and aetiological factors (Lombardi 1993). Candida albicans is the most common of the isolates amongst denture stomatitis patients (Pires 2002). Until recently, however there has been controversy concerning the aetiology of the disease. Although some earlier investigators linked denture stomatitis with trauma or bacterial infection, others had isolated candida albicans from the mouths of patients with this condition (Radford 1999; Webb 1998a). It has been recently shown that the presence of candida albicans in denture stomatitis is probably related to an extensive degree of inflammation (Barbeau 2003) and that denture stomatitis is usually associated with the detection of candida species while other factors such as denture hygiene habits (Lombardi 1993; Pires 2002), and trauma (Webb 1998a) are important to the development of the disease. There is also some recent evidence indicating that nocturnal wear of dentures and smoking are other significant risk indicators to denture stomatitis (Barbeau 2003). Certain systemic conditions such as diabetes (Guggenheimer 2000) and/or defects in the immune system may also predispose the host to candida‐associated denture stomatitis (Webb 1998a).

There are several reports about the prevalence of denture stomatitis in the dental literature. Recent findings from a Chilean prevalence study indicate that denture stomatitis is the most common lesion amongst Chileans aged 65 years and over, affecting 22.3% of the individuals evaluated in a random sample of Santiago (capital of Chile) inhabitants (Espinoza 2003). In another study where aged individuals were evaluated, a prevalence of 18.3% of denture stomatitis was reported in a representative sample of Germans aged from 65 to 74 years (Reichart 2000). In Finland, the most common oral mucosa lesion affecting denture wearers is also denture stomatitis, with a reported prevalence of 25% (Nevalainen 1997). A Swedish study carried out in the Koster islands showed an image somewhat different, with a prevalence of denture stomatitis of 59.2% (Eliasson 1992). Denture stomatitis is also reported as the most frequent mucosa lesion in institutionalised elderly. A Brazilian report shows a prevalence of 20.0% of denture stomatitis in an institution located in Piracicaba, São Paulo (Jorge Júnior 1991).

There have been several traditional reviews concerning the treatment of denture stomatitis in the literature (Lombardi 1993). Their conclusions vary and cover findings about different treatment regimens, several of which have not been systematically investigated. While some advocate the use of antifungals (Jeganathan 1992; Webb 1998b) such as nystatin and amphotericin B for the treatment of denture stomatitis and consider it effective, at least initially (Webb 1998b), others believe that the use of antimycotic drugs seems unnecessary (Arendorf 1987). Unfortunately, therapeutic failure, when using antifungal agents (Webb 1998b) or when the local or systemic predisposing factors are not corrected (Budtz‐Jorgensen 1990), is not uncommon (Ellepola 2000). It is also not uncommon that the disease recurs if the appropriate therapy is stopped (Webb 1998b). Some alternatives to antifungal agents have also been described in the literature. The use of disinfecting agents, such as sodium hypochlorite (Webb 1998b) and chlorhexidine (Budtz‐Jorgensen 1990), aimed to eliminate denture plaque (Arendorf 1987; Jeganathan 1992) and to control colonization of the fitting denture surface by candida (Budtz‐Jorgensen 1990) and also some new alternatives, such as the use of microwave irradiation that, at a specified setting and exposure time, are bactericidal and fungicidal (Webb 1998b). Correction of denture faults (Arendorf 1987; Jeganathan 1992) and discontinuous denture wearing (Jeganathan 1992) are also considered important for the treatment of denture stomatitis.

Since it has not been established in the literature which is the best intervention to treat denture stomatitis we will perform a systematic review aimed to compare all randomized controlled trials where antimicrobial agents, denture replacement, correction of denture faults and other types of treatment as well as combinations of different types of treatments were used to treat denture stomatitis.

Objectives

To assess the efficacy and effectiveness of interventions (which may be placebo) to treat denture stomatitis.

The following primary null hypothesis will be tested for comparison between groups receiving or not active treatment against denture stomatitis:

  • There is no difference between active treatment or placebo for the treatment of stomatitis caused by dentures.

Methods

Criteria for considering studies for this review

Types of studies

All randomized controlled clinical trials (RCTs) comparing agents prescribed to treat denture stomatitis. A period of at least 7 days of treatment will be considered for including a clinical trial in the review.

Types of participants

Anyone with denture stomatitis.

Types of interventions

  • Active agents: any agent or procedure prescribed to treat denture stomatitis.

  • Control: may be placebo or no treatment, or another active intervention (e.g. positive control).

Types of outcome measures

Primary outcomes

  • Relief of symptoms (pain and burning).

  • Remission of clinical signs of stomatitis caused by dentures in all.

  • Denture stomatitis in all its degrees of severity (pin‐point hyperemia, diffuse hyperemia and granular stomatitis).

Secondary outcome

  • Elimination of fungi infection measured using salivary counts of candida species and candida albicans and other techniques for evaluating candida species and candida albicans such as imprint cultures and oral rinse techniques.

Other outcomes

  • Patient quality of life after remission of clinical signs.

  • Cost of intervention including financial losses to patient.

  • Adverse events and side effects of the agent of procedure prescribed to treat the patient.

Search methods for identification of studies

The search will attempt to identify all relevant trials irrespective of language. Any paper published in a language other than English, Portuguese or Spanish will be translated by members of The Cochrane Collaboration.

The following databases will be searched:
(1) the Cochrane Oral Health Group Trials Register
(2) the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, current issue)
(3) MEDLINE (1966 to date) and EMBASE (1974 to date) by OVID software
(4) the National Research Register (NRR) and Clinical Trials Register will also be searched in all fields using the following words: stomatitis, dentures, mucositis, oral candidose, oral lesion, oral ulceration.

Sensitive search strategies will be developed for each database using a combination of free text and MeSH terms. SeeAppendix 1; Appendix 2.

The citation list of relevant publications, abstracts of scientific meetings and list of included studies will also be checked through handsearching and contacting experts in the field to identify further reports of trials. No language or other limitations will be imposed.

The reference list of related review articles and all other articles will be checked for further trials. Authors of trial reports and specialists in the field known to the authors will be contacted concerning further published and unpublished trials. This review will be updated every 2 years using the Cochrane Oral Health Group Trials Register, CENTRAL, EMBASE and MEDLINE.

Data collection and analysis

The titles and abstracts (when available) of all reports identified through the searches will be screened by two authors (Fernando Neves Hugo (FNH) and Juliana Balbinot Hilgert (JBH)). Any discrepancies will be resolved by a co‐author (Lídia Rosi Medeiros (LRM)). When a trial appears to meet the inclusion criteria a hard copy of its full report will be obtained. Further information will be sought from the authors of the trials only when papers contain insufficient information to make a decision about eligibility. The authors will be blinded with respect to the trials information regarding the authors of the trials, journals in which they were published, date of publication and sources of financial support. If a trial is identified where there is insufficient information available in the title or abstract to make a clear decision, a full copy of it will be attained. All full reports obtained using the search methods employed in this review will be independently assessed by two authors (FNH and JBH) in order to verify whether these trials meet or not the inclusion criteria.

The review will be conducted using the software Review Manager (RevMan) provided by The Cochrane Collaboration. The quality assessment of the trials included in the review will be undertaken independently by two authors (FNH and JBH). The trials will be assessed on four criteria as follows: allocation concealment of treatment (A = adequate, B = unclear, C = inadequate); blinding of patients (0 = no, 1 = yes, 2 = unclear); outcome assessors (0 = no, 1 = yes, 2 = unclear); and information on reasons for withdrawal by trial group (0 = no, 1 = yes). The agreement between the authors will be assessed by calculating the Kappa score.

Data extraction

All data will be extracted by two authors independently using data extraction forms. Study outcomes will be dichotomized in order to maximize availability of similar outcome data. In the case of a discrepancy between authors, a consensus will be sought.

(1) Trial characteristics

Method of randomization, in order of preference, as follows:

  • third party randomization (pharmacy, computer or telephone);

  • true randomization (opaque numbered envelope or register).

Study design:

  • duration of follow up;

  • type of follow up;

  • presence or absence of blinding to allocation.

Size of study:

  • number of individuals recruited;

  • number of individuals randomized;

  • number of individuals excluded;

  • number of individuals withdrawn and lost to follow up;

  • number of individuals analyzed.

Study setting:

  • single‐centre or multicentre;

  • location;

  • timing and duration.

Analysis:

  • whether a power calculation was performed and adhered to;

  • whether 'intention‐to‐treat' analysis was performed by authors.

Criteria for treatment of denture stomatitis:

  • indications specified.

(2) Characteristics of the study participants

Baseline characteristics:

  • age;

  • indications for treatment;

  • methods used to define and diagnose participants;

  • how participants were found;

  • reasons to exclude participants.

Treatment characteristics:

  • pre‐treatment preparation;

  • level of training of dentists.

(3) Interventions

All randomized controlled trials (RCTs) comparing an active treatment for denture stomatitis with a placebo or other active treatment.

(4) Outcomes

Primary outcomes:

  • relief of symptoms (pain and burning) and remission of clinical signs;

  • denture stomatitis in all its degrees of severity (pin‐point hyperemia, diffuse hyperemia and granular stomatitis).

Secondary outcomes:

  • elimination of fungi infection (salivary counts of candida species or salivary counts of candida albicans).

Other outcomes:

  • patient quality of life after remission of clinical signs;

  • cost of intervention including financial losses to patient;

  • adverse events and side effects of the agent of procedure prescribed to treat the patient.

Data analysis

For dichotomous outcomes the estimate of effect of an intervention will be expressed as risk ratios with its respective 95% confidence intervals. Statistical heterogeneity between the results of different studies will be examined by inspecting the scatter in the data points on the graphs and the overlap in their confidence intervals and, more formally, by checking the results of Chi2 tests. The outcomes will be pooled statistically where no clinical heterogeneity is apparent. When possible, subgroup analyses will be undertaken to compare: the results for different types of dentures (complete or partial removable), type of interventions, duration of follow up. Only if there are trials of similar comparisons reporting the same type of outcome measures a meta‐analysis will be attempted.

Continuous data will be combined for meta‐analysis. Using RevMan software, we will use mean and standard deviations to derive a weighted mean difference (WMD) with 95% confidence intervals using a fixed‐effect model. As a general rule, a fixed‐effect model will be used for calculations of summary estimates and their 95% confidence intervals unless there are significant heterogeneity (variations) in which case results will be confirmed using a random‐effects statistical model.

For categorical outcomes we will relate the numbers reporting an outcome to each group. Results for each study will be expressed as risk ratios with 95% confidence intervals and combined for meta‐analysis with RevMan software using the Peto‐modified Mantel‐Haenszel method. An increase in the odds of a particular outcome will be displayed graphically in the meta‐analysis to the right of the centre‐line and a decrease in the odds of an outcome will be displayed graphically to the left of the centre‐line.

Sensitivity analyses will be undertaken to examine the effect of randomization, allocation concealment and blind outcome assessment on the overall estimates of effect.

The studies will be categorized as low, moderate and high risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions.

Improving and updating reviews

This review will be updated every 2 years. Even if no substantial evidence is found and no amendment is needed, the results of the last search will be clearly stated.