Candida Albicans InfectionPhase 3NCT04837664
Curcumin; Rose Bengal; Denture Stomatitis
A Phase 3 study testing Curcumin, Rose Bengal and Nystatin in people with Candida Albicans Infection and Cigarette Smoking, run by King Saud University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Candida Albicans Infection, Cigarette Smoking
- What is being tested?
- Curcumin, Rose Bengal and Nystatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Jul 2018to 1 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Curcumin, Rose Bengal, Nystatin
- Keywords
- Candida albicans, curcumin, nystatin, photodynamic therapy, rose bengal
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.
Rose BengalDrug
Rose bengal was bought from Sigma®, USA, and its solution was freshly prepared by mixing rose bengal powder with phosphate-buffered saline.
NystatinDrug
Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds
| Study group | Role | What they receive |
|---|---|---|
| Rose Bengal-mediated Photodynamic therapy | Experimental | 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. Receives: Drug: Rose Bengal |
| Curcumin-mediated photodynamic therapy | Experimental | 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. Receives: Drug: Curcumin |
| Nystatin therapy | Active comparator | Participants belonging to the Nystatin group were administered the topical nystatin-based antifungal drug. Receives: Drug: Nystatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candida albican
Counts of Candida colony calculated as colony forming unit (CFU)/mL
Measured: 12 weeks
Secondary outcomes (1)
Candida species
Prevalence of other Candida species
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start3 Jul 2018
- Primary completion12 Dec 2020
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida Albicans InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Labban Nawwaf, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837664
- Sponsor's protocol ID
- KingSaudUni
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04837664
- Acronym / sponsor ID
- KingSaudUni
- Conditions
- Candida Albicans Infection, Cigarette Smoking
- Keywords
- Candida albicans, curcumin, nystatin, photodynamic therapy, rose bengal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rose Bengal-mediated Photodynamic therapy | Experimental | Drug: Rose BengalParticipants 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. |
| Curcumin-mediated photodynamic therapy | Experimental | Drug: CurcuminParticipants 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. |
| Nystatin therapy | Active comparator | Drug: NystatinParticipants belonging to the Nystatin group were administered the topical nystatin-based antifungal drug. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminCurcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline. | Drug | Curcumin-mediated photodynamic therapy |
| Rose BengalRose bengal was bought from Sigma®, USA, and its solution was freshly prepared by mixing rose bengal powder with phosphate-buffered saline. | Drug | Rose Bengal-mediated Photodynamic therapy |
| NystatinRinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds | Drug | Nystatin therapy |
Primary outcome
Candida albican
Time frame: 12 weeks
Counts of Candida colony calculated as colony forming unit (CFU)/mL
1 secondary outcome
Candida species
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcumin, Rose Bengal and Nystatin in people with Candida Albicans Infection and Cigarette Smoking, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candida albican (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.