NCT04837664

Curcumin; Rose Bengal; Denture Stomatitis

Efficacy of Rose Bengal and Curcumin Mediated Photodynamic Therapy in the Treatment of Denture Stomatitis in Patients With Habitual Cigarette Smokers: a Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 50 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Cigarette smoking in conjugation with bad oral hygiene is considered a typical predisposing factor for many oral diseases including denture stomatitis. This study investigated the effect of Rose Bengal (RB)-and Curcumin (CUR)-mediated photodynamic therapy (PDT) in comparison with nystatin therapy in the intervention of denture stomatitis in cigarette smokers. Overall, 45 habitual cigarette smokers aged \~58 years having denture stomatitis were categorized into three groups: Group-I - RB-mediated PDT, Group-II - CUR-mediated PDT, and Group-III - Nystatin therapy. The primary outcome of the interest was: counts of Candida colony from denture surface and palatal mucosa, calculated as CFU/mL, whereas the prevalence of Candida species determined in 3 research groups comprised the secondary outcome. Oral swab specimens were gathered from the denture surfaces and palatal mucosa. All clinical assessments were performed at baseline, 6 weeks, and 12 weeks. C. albicans was the most prevalent yeast identified on both denture surfaces and palatal mucosa, followed by C. tropicalis and C. glabrata. A considerable decrease in the CFU/mL scores were observed in Group-I and Group-II at the end of the interventions and on the 12-week follow-up (p\<0.05). Group-I, II, and III demonstrated clinical efficacy rates of 53%, 51%, and 49%, respectively. CUR-and RB-mediated PDT was found to be as effective as topical Nystatin therapy for the intervention of denture stomatitis among cigarette smokers.

Conditions

• Candida Albicans Infection
• Cigarette Smoking

Interventions

Type	Name	Description
DRUG	Curcumin	Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.
DRUG	Rose Bengal	Rose bengal was bought from Sigma®, USA, and its solution was freshly prepared by mixing rose bengal powder with phosphate-buffered saline.
DRUG	Nystatin	Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds

Timeline

• Start date: 2018-07-03
• Primary completion: 2020-12-12
• Completion: 2021-05-01
• First posted: 2021-04-08
• Last updated: 2021-04-08

Locations

1 site across 1 country: Saudi Arabia