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Curcumin; Rose Bengal; Denture Stomatitis

Primary Purpose

Candida Albicans Infection, Cigarette Smoking

Status
Unknown status
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Curcumin
Rose Bengal
Nystatin
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candida Albicans Infection focused on measuring Candida albicans, curcumin, nystatin, photodynamic therapy, rose bengal

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Rose Bengal-mediated Photodynamic therapy

Curcumin-mediated photodynamic therapy

Nystatin therapy

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

Candida albican
Counts of Candida colony calculated as colony forming unit (CFU)/mL

Secondary Outcome Measures

Candida species
Prevalence of other Candida species

Full Information

First Posted
April 6, 2021
Last Updated
April 6, 2021
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT04837664
Brief Title
Curcumin; Rose Bengal; Denture Stomatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
December 12, 2020 (Actual)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candida Albicans Infection, Cigarette Smoking
Keywords
Candida albicans, curcumin, nystatin, photodynamic therapy, rose bengal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rose Bengal-mediated Photodynamic therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Curcumin-mediated photodynamic therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Nystatin therapy
Arm Type
Active Comparator
Arm Description
Participants belonging to the Nystatin group were administered the topical nystatin-based antifungal drug.
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.
Intervention Type
Drug
Intervention Name(s)
Rose Bengal
Intervention Description
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
Intervention Name(s)
Nystatin
Intervention Description
Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds
Primary Outcome Measure Information:
Title
Candida albican
Description
Counts of Candida colony calculated as colony forming unit (CFU)/mL
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Candida species
Description
Prevalence of other Candida species
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
King Saud University
City
Riyadh
ZIP/Postal Code
11564
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Curcumin; Rose Bengal; Denture Stomatitis

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