The Effectiveness of Palatal Brushing on Denture Stomatitis

Study Overview
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Brief Summary
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Denture stomatitis (DS) is an oral biofilm associated inflammatory disease of the palatal mucosa. It is the most prevalent oral disease and the main indicator of poor oral health among denture wearers, affecting one-third of all complete denture wearers. The etiology of DS is multifactorial, with documented role of mechanical trauma, bacteria and fungi. Risk factors may include, poor oral hygiene and nocturnal use of dentures. However, the evidence is ambiguous, inconclusive and recurrence following routine antifungal therapy is common. The proposed study is a phase II clinical trial to evaluate the efficacy of palatal brushing in reducing the colony forming unit (CFU) count and clinical inflammation. The assessment of change in CFU count and clinical inflammation will be carried out at baseline, 3 months and 6 months.

Official Title
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Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial

Conditions
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Denture Stomatitis

Intervention / Treatment
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* Behavioral: Palatal brushing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Wearing a maxillary and mandibular complete conventional denture Having moderate to severe signs of denture stomatitis according to Schwartz index Providing consent prior to study. Exclusion Criteria: Oral mucosal lesions other than denture stomatitis. Systemic conditions which predispose to Candida specie infection such as uncontrolled diabetes and xerostomia. History of chemotherapy/radiotherapy. Used antibiotics, steroidal or antifungal agents in the 4 weeks prior to the study. Scheduled to replace existing dentures with new ones during the length of the trial. Already using palatal brushing as a routine oral hygiene procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Palate Brushing<br>In this group the intervention is palatal brushing, performed by the participants following each meal for a period of 6 months. This will be performed using the provided toothbrush (device). The results will determine if brushing the palate in an efficient intervention for reducing the microbial count and inflammation associated with denture stomatitis. | Behavioral: Palatal brushing<br>* Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.<br>|
| No Intervention: Regular Oral Hygiene<br>The participants in this study arm will not be prescribed or allocated any intervention. The participants will be asked to continue with the regular hygiene and denture maintenance practices for the duration of the trial. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candida species colony forming units | Palatal saliva (swab) and denture sonicate will be analysed for Candida species CFU count at baseline, 3 months and 6 months. The results will be presented as change in mean CFU count. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Inflammation | Change in clinical inflammation will be examined and recorded in both groups at baseline, 3 months and 6 months and presented as change in mean inflammation scores. | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Denture Stomatitis, Denture Erythematous Stomatitis, Prosthesis Stomatitis, Oral Candidiasis, Palatal inflammation