The Effectiveness of Palatal Brushing on Denture Stomatitis
NCT ID: NCT02686632
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2016-09-30
2018-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Palate Brushing
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.
Palatal brushing
Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.
Regular Oral Hygiene
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.
No interventions assigned to this group
Interventions
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Palatal brushing
Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
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McGill University
OTHER
Université de Montréal
OTHER
Responsible Party
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Elham Emami
Associate Professor
Locations
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Université de Montréal
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Phase I clinical trial of the proposed study
Other Identifiers
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FMD-UdeM-EE-2016a
Identifier Type: -
Identifier Source: org_study_id
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