The Effectiveness of Palatal Brushing on Denture Stomatitis

NCT02686632 | Completed DMC

• 1 other identifier: FMD-UdeM-EE-2016a
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Denture Stomatitis

Keywords

Denture Stomatitis; Denture Erythematous Stomatitis; Prosthesis Stomatitis; Oral Candidiasis; Palatal inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Inflammation

  Baseline to 6 months

Study Arms (2)

Palate Brushing

EXPERIMENTAL

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.

Behavioral: Palatal brushing

Regular Oral Hygiene

NO INTERVENTION

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.

Interventions

Palatal brushing BEHAVIORAL

Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.

Palate Brushing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead
• McGill University: collaborator

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3C3J7, Canada

Location

Related Publications (7)

• 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.

  PMID: 20461847 BACKGROUND

• 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.

  PMID: 21463383 BACKGROUND

• 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.

  PMID: 25146182 BACKGROUND

• 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.

  PMID: 20305856 BACKGROUND

• 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.

  PMID: 18434573 BACKGROUND

• 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.

  PMID: 15024360 BACKGROUND

• 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.

  PMID: 28476133 DERIVED

Related Links

• Phase I clinical trial of the proposed study

MeSH Terms

Conditions

Stomatitis, Denture; Candidiasis, Oral

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 19, 2016
• Study Start: September 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-05

Locations

CA (1)