The Effect of Palatal Brushing on Denture Stomatitis

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Elham Emami, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01643876
First received: July 16, 2012
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers.

However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa.

After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes).

Tested Hypotheses:

  • There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing.
  • There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.

Condition Intervention Phase
Denture Stomatitis
Behavioral: Palatal brushing
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Palatal Inflammation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    Modified Newton classification 0: Healthy mucosa

    1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation

    1. Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue
    2. Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue
    3. Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index

    0: Normal tissue

    1. Mild inflammation
    2. Moderate inflammation
    3. Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)


Secondary Outcome Measures:
  • Candida Species Count [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.


Enrollment: 48
Study Start Date: July 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palatal brushing
Palatal brushing after each meal for 3 months.
Behavioral: Palatal brushing
Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Good general health.
  • Completely edentulous maxilla.
  • Currently wearing complete upper dentures.
  • A clinical diagnosis of denture stomatitis.

Exclusion Criteria:

  • Conditions known to promote Candida carriage such as diabetes, anemia, xerostomia, immunosuppression, chemotherapy and radiotherapy.
  • Use of antibiotics, antifungal agents or corticosteroids at least 4 weeks before the study.
  • Previous palatal brushing habit.
  • Changing of the existing prosthesis during the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643876

Locations
Brazil
University of Sao Paulo - Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil
Canada, Quebec
Faculté de Médecine Dentaire, Université de Montréal
Montréal, Quebec, Canada
Sponsors and Collaborators
Université de Montréal
University of Sao Paulo
Investigators
Principal Investigator: Elham Emami, DDS, PhD Université de Montréal
Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Elham Emami, D.D.S., M. Sc., Ph. D, Assistant Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01643876     History of Changes
Other Study ID Numbers: FMD-UdeM-EE-2012a
Study First Received: July 16, 2012
Results First Received: July 23, 2013
Last Updated: December 23, 2013
Health Authority: Canada: Institutional Review Board

Keywords provided by Université de Montréal:
Denture stomatitis
Denture Plaque
Oral Candidiasis
Oral Hygiene

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

ClinicalTrials.gov processed this record on September 22, 2014