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OpenTrials
Completed

NCT Number: NCT02686632

The Effectiveness of Palatal Brushing on Denture Stomatitis

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.

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Key information

Conditions

Denture Stomatitis Bacterial Infections and Mycoses Candidiasis Candidiasis, Oral Infections Mouth Diseases Mycoses Stomatitis Stomatitis, Denture Stomatognathic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Montréal

Montreal, Quebec, H3C3J7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palatal brushing

Behavioral

Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Collaborators

  • McGill University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2016
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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