Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment
ConditionOral Leukoplakia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Coenzyme Q10 gel
Other interventionApplication will be performed 2-3 times daily for 4 weeks.
Topical curcumin gel
Other interventionApplication will be performed 2-3 times daily for 4 weeks.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Topical Coenzyme Q10 gelExperimental treatment 1 intervention
Group B: Topical curcumin gelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in lesion size
measured clinically with a periodontal probe and/or digital images
Time frame
baseline, 4 weeks, and 12 weeksSecondary outcomes
1
Change in salivary markers
Unstimulated whole saliva will be collected to assess salivary oxidative stress
Time frame
baseline, 4 weeks, and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov