Curcumin; Rose Bengal; Denture Stomatitis

NCT ID: NCT04837664

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2021-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rose Bengal-mediated Photodynamic therapy

Participants belonging to the rose bengal mediated photodynamic therapy, their dentures and oral cavity were illuminated using the LED device for 26 minutes (37.5 J/cm2). The photosensitizer rose bengal was sprayed on the palate and dentures for half-hour. To irradiate the palate, the investigator handled the other LED device; the circular platform having LEDs was put within the patient's oral cavity and the illumination of the palate was carried out for 20 minutes (122 J/cm2). The PDT was carried out thrice per week for a half month (6 sessions) in each participant.

Group Type: EXPERIMENTAL

Rose Bengal

Intervention Type: DRUG

Rose bengal was bought from Sigma®, USA, and its solution was freshly prepared by mixing rose bengal powder with phosphate-buffered saline.

Curcumin-mediated photodynamic therapy

Participants belonging to the curcumin mediated photodynamic therapy, their dentures and oral cavity were illuminated using the LED device for 26 minutes (37.5 J/cm2). The photosensitizer curcumin was sprayed on the palate and dentures for half-hour. To irradiate the palate, the investigator handled the other LED device; the circular platform having LEDs was put within the patient's oral cavity and the illumination of the palate was carried out for 20 minutes (122 J/cm2). The PDT was carried out thrice per week for a half month (6 sessions) in each participant.

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.

Nystatin therapy

Participants belonging to the Nystatin group were administered the topical nystatin-based antifungal drug.

Group Type: ACTIVE_COMPARATOR

Nystatin

Intervention Type: DRUG

Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds

Interventions

Curcumin

Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.

Intervention Type: 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.

Intervention Type: DRUG

Nystatin

Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

The inclusion criteria consisted of the following: (1) completely edentulous participants; (2) removable complete denture wearers diagnosed with denture stomatitis (loss of filiform papillae, erythema, and feeling of mucosal burning); and (3) habitual cigarette smokers (individuals smoking at least 1 cigarette per day since ≥3 years).

Exclusion Criteria:

The exclusion criteria consisted of the following: (1) individuals who received steroids, antifungals, or antibiotics over the past 90 days before the initiation of the study; (2) lactating or pregnant women; (3) individuals who had been using the same denture over the past ten years; individuals who underwent cancer treatment (chemotherapy or radiotherapy); (5) patients who are immunocompromised, anemics, or diabetics; (6) habitual alcohol drinkers; and (7) participants who refused to sign the informed consent document.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Labban Nawwaf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Saud University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

KingSaudUni

Identifier Type: -

Identifier Source: org_study_id