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NCT Number: NCT07331935

Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment

Oral leukoplakia (OL) is recognized as the most common potentially malignant disorder of the oral mucosa. The pathogenesis of OL is complex and multifactorial, with oxidative stress playing a central role. Topical antioxidants have gained attention as therapeutic options to help stabilize lesions and potentially prevent malignant transformation. Both CoQ10 and curcumin have demonstrated a clinical success as strong antioxidants showing their capacity to reduce the lesion size and to stabilize the disease, ultimately preventing progression into oral malignancy. Aim: This study aims to clinically and biochemically assess the effectiveness of topical Coenzyme Q10 and Curcumin in the management of homogeneous oral leukoplakia.

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Key information

Conditions

Oral Leukoplakia Head and Neck Neoplasms Leukoplakia Leukoplakia, Oral Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Stomatognathic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Location status: Recruiting

Location contact

Faculty of Dentistry

CONTACT

(203) 4868308

Tasneem Saleem, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically and histologically diagnosed with homogeneous oral leukoplakia not indicated for surgical excision .
  • Lesions accessible for topical application.
  • Willing to sign informed consent and comply with study instructions and return to follow up

Exclusion criteria

  • Moderate-to-severe dysplasia, carcinoma in situ, or invasive oral cancer.
  • Presence of any visible oral lesions except for oral leukoplakia.
  • Active periodontal diseases as this can confound salivary biomarkers.
  • Significant systemic illness or immunosuppression.
  • Patients who have taken systemic or topical antioxidant supplements within the last four weeks will be excluded to avoid confounding effects on salivary biomarkers.
  • Pregnant and lactating women will be excluded due to hormonal changes that may alter oxidative stress and ethical considerations.
  • Patients unwilling or unable to comply with study requirements.

Treatment and study plan

Coenzyme Q10 gel

Other

Application will be performed 2-3 times daily for 4 weeks.

Topical curcumin gel

Other

Application will be performed 2-3 times daily for 4 weeks.

Primary outcomes

  1. Change in lesion size

    Time frame: baseline, 4 weeks, and 12 weeks

    measured clinically with a periodontal probe and/or digital images

Secondary outcomes

  1. Change in salivary markers

    Time frame: baseline, 4 weeks, and 12 weeks

    Unstimulated whole saliva will be collected to assess salivary oxidative stress

Study contacts

Contact information is provided by the study sponsor or research team.

Tasnim Saleem, BDS

CONTACT

[email protected]

010 28946295 ext. 002

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Clinical and Biochemical Assessment of the Effectivness of Topical Coenzyme Q10 and Topical Curcumin in Managment of Oral Leukoplakia (A Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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