The Effectiveness of Palatal Brushing on Denture Stomatitis
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|ClinicalTrials.gov Identifier: NCT02686632|
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : February 3, 2017
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.
|Condition or disease||Intervention/treatment|
|Denture Stomatitis||Behavioral: Palatal brushing|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Palate Brushing
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
Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.
No Intervention: Regular Oral Hygiene
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.
- Candida species colony forming units [ Time Frame: Baseline to 6 months ]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.
- Clinical Inflammation [ Time Frame: Baseline to 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686632
|Contact: Elham Emami, D.D.S., M. Sc., Ph. Dfirstname.lastname@example.org|
|Université de Montréal||Recruiting|
|Montreal, Quebec, Canada, H3C3J7|
|Contact: Dr. Elham Emami 5143436053 email@example.com|