Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID07331935

Clinical and Biochemical Assessment of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Management

Led by Alexandria University · Updated on 2026-01-12

34

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Oral leukoplakia (OL) is the most common potentially malignant disorder of the mouth's lining, with complex causes including oxidative stress. Researchers are studying the effects of two topical antioxidants, Coenzyme Q10 and curcumin, which have shown promise in reducing lesion size and stabilizing the disease to potentially prevent it from turning into oral cancer. This randomized controlled clinical trial aims to assess the clinical and biochemical effectiveness of these treatments for managing homogeneous oral leukoplakia. Participants will apply either Coenzyme Q10 gel or topical curcumin gel directly to their lesions 2 to 3 times daily for 4 weeks. This study includes two experimental groups, each receiving one of the topical antioxidant gels. The treatments are applied locally to accessible lesions, with the trial monitoring participants over this 4-week treatment period. Throughout the study, researchers will measure changes in lesion size and salivary markers at the start, after 4 weeks, and again at 12 weeks to evaluate treatment effects. Participants must be willing to follow study instructions and attend follow-up visits. Safety and effectiveness are monitored through clinical and biochemical assessments, with total participation lasting at least 12 weeks from baseline to final evaluation.

CONDITIONS

Brief Title

Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically and histologically diagnosed with homogeneous oral leukoplakia not needing surgical removal
  • Oral lesions accessible for topical application
  • Willing to sign informed consent and follow study instructions with return for follow-up
Not Eligible

You will not qualify if you...

  • Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer
  • Presence of any visible oral lesions other than oral leukoplakia
  • Active periodontal disease
  • Significant systemic illness or immunosuppression
  • Use of systemic or topical antioxidant supplements within the last 4 weeks
  • Pregnant or breastfeeding women
  • Unwilling or unable to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 4 weeks

Participants apply topical Coenzyme Q10 gel or topical curcumin gel 2 to 3 times daily for 4 weeks.

Visits at baseline and Week 4

Follow-up

Duration - 8 weeks

Participants are monitored after treatment to assess changes in lesion size and salivary markers.

Visit at Week 12

Trial Site Locations

Total: 1 location

1

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

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Research Team

T

Tasnim Saleem, BDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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