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The Effectiveness of Palatal Brushing on Denture Stomatitis

Primary Purpose

Denture Stomatitis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Palatal brushing
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Denture Stomatitis focused on measuring Denture Stomatitis, Denture Erythematous Stomatitis, Prosthesis Stomatitis, Oral Candidiasis, Palatal inflammation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Palate Brushing

Regular Oral Hygiene

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Candida species colony forming units
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

Clinical Inflammation
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.

Full Information

First Posted
February 15, 2016
Last Updated
May 1, 2018
Sponsor
Université de Montréal
Collaborators
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT02686632
Brief Title
The Effectiveness of Palatal Brushing on Denture Stomatitis
Official Title
Improving Practice Guidelines for the Treatment of Denture-related Erythematous Stomatitis: A Pragmatic International Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal
Collaborators
McGill University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Denture Stomatitis
Keywords
Denture Stomatitis, Denture Erythematous Stomatitis, Prosthesis Stomatitis, Oral Candidiasis, Palatal inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palate Brushing
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular Oral Hygiene
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Palatal brushing
Intervention Description
Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.
Primary Outcome Measure Information:
Title
Candida species colony forming units
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Clinical Inflammation
Description
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.
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3C3J7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20461847
Citation
Jainkittivong A, Aneksuk V, Langlais RP. Oral mucosal lesions in denture wearers. Gerodontology. 2010 Mar;27(1):26-32. doi: 10.1111/j.1741-2358.2009.00289.x.
Results Reference
background
PubMed Identifier
21463383
Citation
Gendreau L, Loewy ZG. Epidemiology and etiology of denture stomatitis. J Prosthodont. 2011 Jun;20(4):251-60. doi: 10.1111/j.1532-849X.2011.00698.x. Epub 2011 Apr 4.
Results Reference
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PubMed Identifier
25146182
Citation
Slade GD, Akinkugbe AA, Sanders AE. Projections of U.S. Edentulism prevalence following 5 decades of decline. J Dent Res. 2014 Oct;93(10):959-65. doi: 10.1177/0022034514546165. Epub 2014 Aug 21.
Results Reference
background
PubMed Identifier
20305856
Citation
de Oliveira CE, Gasparoto TH, Dionisio TJ, Porto VC, Vieira NA, Santos CF, Lara VS. Candida albicans and denture stomatitis: evaluation of its presence in the lesion, prosthesis, and blood. Int J Prosthodont. 2010 Mar-Apr;23(2):158-9.
Results Reference
background
PubMed Identifier
18434573
Citation
Emami E, de Grandmont P, Rompre PH, Barbeau J, Pan S, Feine JS. Favoring trauma as an etiological factor in denture stomatitis. J Dent Res. 2008 May;87(5):440-4. doi: 10.1177/154405910808700505.
Results Reference
background
PubMed Identifier
15024360
Citation
Cross LJ, Williams DW, Sweeney CP, Jackson MS, Lewis MA, Bagg J. Evaluation of the recurrence of denture stomatitis and Candida colonization in a small group of patients who received itraconazole. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Mar;97(3):351-8. doi: 10.1016/j.tripleo.2003.10.006.
Results Reference
background
PubMed Identifier
28476133
Citation
de Souza RF, Khiyani MF, Chaves CAL, Feine J, Barbeau J, Fuentes R, Borie E, Crizostomo LC, Silva-Lovato CH, Rompre P, Emami E. Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial. Trials. 2017 May 5;18(1):211. doi: 10.1186/s13063-017-1947-y.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/25010873
Description
Phase I clinical trial of the proposed study

Learn more about this trial

The Effectiveness of Palatal Brushing on Denture Stomatitis

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