The Effectiveness of Palatal Brushing on Denture Stomatitis

Denture Stomatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686632
• Other study ID #: FMD-UdeM-EE-2016a
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Denture Stomatitis
• Stomatitis
• Stomatitis, Denture

Intervention

Behavioral:
• Palatal brushing
Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.

Locations

Country	Name	City	State
Canada	Université de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Montréal	McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

de Oliveira CE, Gasparoto TH, Dionísio 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. — View Citation

Emami E, de Grandmont P, Rompré 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. — View 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. Review. — View Citation

Jainkittivong A, Aneksuk V, Langlais RP. Oral mucosal lesions in denture wearers. Gerodontology. 2010 Mar;27(1):26-32. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 6 months
Secondary	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.	Baseline to 6 months

External Links

•   Phase I clinical trial of the proposed study