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Curcumin; Rose Bengal; Denture Stomatitis

NCT04837664 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-04-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-03
Primary Completion
2020-12-12
Completion
2021-05-01

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837664 on ClinicalTrials.gov