Curcumin; Rose Bengal; Denture Stomatitis

Sponsor

King Saud University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04837664

Collaborator

(none)

Enrollment

Location

Arms

33.9

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candida Albicans Infection Cigarette Smoking	Drug: Curcumin Drug: Rose Bengal Drug: Nystatin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 3, 2018

Actual Primary Completion Date :

Dec 12, 2020

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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.	Drug: Curcumin Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.
Active Comparator: Nystatin therapy Participants belonging to the Nystatin group were administered the topical nystatin-based antifungal drug.	Drug: Nystatin Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds

Arm

Intervention/Treatment

Experimental: 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.

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.

Experimental: 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.

Drug: Curcumin

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

Active Comparator: Nystatin therapy

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

Drug: Nystatin

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

Outcome Measures

Primary Outcome Measures

Candida albican [12 weeks]
Counts of Candida colony calculated as colony forming unit (CFU)/mL

Secondary Outcome Measures

Candida species [12 weeks]
Prevalence of other Candida species

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.