The Effectiveness of Palatal Brushing on Denture Stomatitis

Université de Montréal52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Denture Stomatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 months

Secondary Outcomes

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.