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

July 10, 2017 updated by: Mostafa Abdelsamie Bakry Nafie, Cairo University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 7 days
pain
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: fatheya zahran, professor, faculty of dentistry -CairoU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 5, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1990 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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