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The Effect of Palatal Brushing on Denture Stomatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643876
First Posted: July 18, 2012
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Elham Emami, Université de Montréal
  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: Intervention Model: Single Group Assignment
Masking: None (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 Elham Emami, Université de Montréal:

Primary Outcome Measures:
  • Palatal Inflammation [ Time Frame: 3 months ]

    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 ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Elham Emami, D.D.S., M. Sc., Ph. D, Assistant Professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01643876     History of Changes
Obsolete Identifiers: NCT02201745
Other Study ID Numbers: FMD-UdeM-EE-2012a
First Submitted: July 16, 2012
First Posted: July 18, 2012
Results First Submitted: July 23, 2013
Results First Posted: January 22, 2014
Last Update Posted: January 22, 2014
Last Verified: December 2013

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

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