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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
McGill University
Information provided by (Responsible Party):
Elham Emami, Université de Montréal

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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. D 5143436053 elham.emami@umontreal.ca

Canada, Quebec
Université de Montréal Recruiting
Montreal, Quebec, Canada, H3C3J7
Contact: Dr. Elham Emami    5143436053    elham.emami@umontreal.ca   
Sponsors and Collaborators
Université de Montréal
McGill University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elham Emami, Associate Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT02686632     History of Changes
Other Study ID Numbers: FMD-UdeM-EE-2016a
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Elham Emami, Université de Montréal:
Denture Stomatitis
Denture Erythematous Stomatitis
Prosthesis Stomatitis
Oral Candidiasis
Palatal inflammation

Additional relevant MeSH terms:
Stomatitis, Denture
Mouth Diseases
Stomatognathic Diseases