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| Name | Class |
|---|---|
| McGill University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palatal brushing | Behavioral | Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Montréal | Montreal | Quebec | H3C3J7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20461847 | Background | 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. | |
| 21463383 | 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. |
| Label | URL |
|---|---|
| Phase I clinical trial of the proposed study | View source |
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| ID | Term |
|---|---|
| D013282 | Stomatitis, Denture |
| D002180 | Candidiasis, Oral |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002177 | Candidiasis |
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| 25146182 | 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. |
| 20305856 | 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. |
| 18434573 | 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. |
| 15024360 | 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. |
| 28476133 | Derived | 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. |
| D009181 |
| Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |