Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer

Not Applicable

• Conditions: Oral Aphthous Ulcer
• Interventions: Drug: topical coenzyme Q10 gel; Drug: Carpabol gel

• Registration Number: NCT03213769
• Lead Sponsor: Cairo University

Brief Summary

Recurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants.

Detailed Description

Double randomized clinical trial study using two parallel group suffer from oral aphthous ulcer one take antioxidant topical q10gel and other group take placebo carpabol gel two times per day for seven days measuring outcome at fourth and seventh day including pain; healing period and clinical parameters.

Sample size of study include 26 in each group.

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07
• Study First Submitted: 2017-07-05
• Study First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Patients with free medical history and no systemic diseases16.
• Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers.
• Patients who agreed to take medications.

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Exclusion Criteria

• Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others.
• Anemic and leukemic patients (using complete blood count investigation)
• Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy.
• Patients treated with any oral topical medications 48h before the study27.
• Pregnant and lactating mothers.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical coenzyme Q10 gel	topical coenzyme Q10 gel	Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
carbapol gel	Carpabol gel	placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

Primary Outcome Measures

Name	Time	Method
visual analogue scale	7 days	pain

Secondary Outcome Measures

Name	Time	Method
scoring system(0-3)	7 days	Erythema surround lesion
cross sectional area William periodontal probe/mm	7 days	Cross sectional area