Clinical trial NCT02686632: 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
Overall status: COMPLETED
Phase: NA
Conditions: Denture Stomatitis
Keywords: Denture Stomatitis
Denture Erythematous Stomatitis
Prosthesis Stomatitis
Oral Candidiasis
Palatal inflammation
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2016-02-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Candida species colony forming units
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Clinical Inflammation
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.