NCT01643876

The Effect of Palatal Brushing on Denture Stomatitis

Phase-I Clinical Trial on the Effect of Palatal Brushing on Denture Stomatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Université de Montréal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Palatal brushing has several advantages including removal of debris and stimulation of blood flow and saliva, which may help to prevent or treat oral diseases, such as denture-related stomatitis in complete denture wearers. However, there is no previous clinical trial testing this effect. Therefore, the investigators goal is to evaluate whether palatal brushing may change the severity of denture stomatitis and counts of microbes on denture and palatal mucosa. After an initial exam and data collection, participants will receive instructions about palatal brushing and they will be assessed after 1 and 3 months. Collection of data will include patient-reported information, intraoral photographs and swabbing (for counting microbes). Tested Hypotheses: * There is no difference in the extent of palatal inflammation in edentulous patients with denture stomatitis before and after 3 months of palatal brushing. * There is no difference in the number of colony forming unit (CFU) of Candida isolated from palate and denture of patients affected by denture stomatitis before and after 3 months of palatal brushing.

Conditions

• Denture Stomatitis

Interventions

Type	Name	Description
BEHAVIORAL	Palatal brushing	Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-07-18
• Last updated: 2014-01-22
• Results posted: 2014-01-22

Locations

2 sites across 2 countries: Brazil, Canada