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

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ClinicalTrials.gov Identifier: NCT03213769
Recruitment Status : Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Mostafa Abdelsamie Bakry Nafie, 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.

Condition or disease Intervention/treatment Phase
Oral Aphthous Ulcer Drug: topical coenzyme Q10 gel Drug: Carpabol gel Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: controlled randimized clinical trial
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores

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.




Primary Outcome Measures :
  1. visual analogue scale [ Time Frame: 7 days ]
    pain


Secondary Outcome Measures :
  1. scoring system(0-3) [ Time Frame: 7 days ]
    Erythema surround lesion

  2. cross sectional area William periodontal probe/mm [ Time Frame: 7 days ]
    Cross sectional area



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213769


Contacts
Contact: mostafa abdelsamie nafie, master +201004165905 mostafa.abdelsamie@dentistry.cu.edu.eg
Contact: Amal Ali, lecturer +201005204628 amal_ali.2009@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
Study Director: fatheya zahran, professor faculty of dentistry -CairoU

Publications:
Responsible Party: Mostafa Abdelsamie Bakry Nafie, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03213769     History of Changes
Other Study ID Numbers: 1990
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mostafa Abdelsamie Bakry Nafie, Cairo University:
oral minor aphthous ulcer
topical Q10 gel
topical antioxidant
oral recurrent aphthous ulcer
oral aphthous stomatitis

Additional relevant MeSH terms:
Ulcer
Stomatitis, Aphthous
Pathologic Processes
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins