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

Study Overview
=================
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.

Official Title
-----------------
Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer

Conditions
-----------------
Oral Aphthous Ulcer

Intervention / Treatment
-----------------
* Drug: topical coenzyme Q10 gel
* Drug: Carpabol gel


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: controlled randimized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: topical coenzyme Q10 gel<br>Q10 gel will give 2 times /day after breakfast and evening meal for 7 days. | Drug: topical coenzyme Q10 gel<br>* Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.<br>|
| Placebo Comparator: carbapol gel<br>placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days. | Drug: Carpabol gel<br>* placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale | pain | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scoring system(0-3) | Erythema surround lesion | 7 days | 
| cross sectional area William periodontal probe/mm | Cross sectional area | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral minor aphthous ulcer, topical Q10 gel, topical antioxidant, oral recurrent aphthous ulcer, oral aphthous stomatitis