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

NCT ID: NCT03213769

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Oral Aphthous Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

controlled randimized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double blind

Study Groups

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topical coenzyme Q10 gel

Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.

Group Type ACTIVE_COMPARATOR

topical coenzyme Q10 gel

Intervention Type DRUG

Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.

carbapol gel

placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

Group Type PLACEBO_COMPARATOR

Carpabol gel

Intervention Type DRUG

placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

Interventions

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topical coenzyme Q10 gel

Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.

Intervention Type DRUG

Carpabol gel

placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Abdelsamie Bakry Nafie

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatheya zahran, professor

Role: STUDY_DIRECTOR

faculty of dentistry -CairoU

Central Contacts

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mostafa abdelsamie nafie, master

Role: CONTACT

+201004165905

Amal Ali, lecturer

Role: CONTACT

+201005204628

References

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Sawair FA. Recurrent aphthous stomatitis: do we know what patients are using to treat the ulcers? J Altern Complement Med. 2010 Jun;16(6):651-5. doi: 10.1089/acm.2009.0555.

Reference Type BACKGROUND
PMID: 20569032 (View on PubMed)

Scully C, Felix DH. Oral medicine--update for the dental practitioner. Aphthous and other common ulcers. Br Dent J. 2005 Sep 10;199(5):259-64. doi: 10.1038/sj.bdj.4812649.

Reference Type BACKGROUND
PMID: 16155535 (View on PubMed)

Momen-Beitollahi J, Mansourian A, Momen-Heravi F, Amanlou M, Obradov S, Sahebjamee M. Assessment of salivary and serum antioxidant status in patients with recurrent aphthous stomatitis. Med Oral Patol Oral Cir Bucal. 2010 Jul 1;15(4):e557-61. doi: 10.4317/medoral.15.e557.

Reference Type BACKGROUND
PMID: 20173724 (View on PubMed)

Littarru GP, Tiano L. Bioenergetic and antioxidant properties of coenzyme Q10: recent developments. Mol Biotechnol. 2007 Sep;37(1):31-7. doi: 10.1007/s12033-007-0052-y.

Reference Type BACKGROUND
PMID: 17914161 (View on PubMed)

Tarakji B, Gazal G, Al-Maweri SA, Azzeghaiby SN, Alaizari N. Guideline for the diagnosis and treatment of recurrent aphthous stomatitis for dental practitioners. J Int Oral Health. 2015 May;7(5):74-80.

Reference Type BACKGROUND
PMID: 26028911 (View on PubMed)

Prakash S, Sunitha J, Hans M. Role of coenzyme Q(10) as an antioxidant and bioenergizer in periodontal diseases. Indian J Pharmacol. 2010 Dec;42(6):334-7. doi: 10.4103/0253-7613.71884.

Reference Type BACKGROUND
PMID: 21189900 (View on PubMed)

Preeti L, Magesh K, Rajkumar K, Karthik R. Recurrent aphthous stomatitis. J Oral Maxillofac Pathol. 2011 Sep;15(3):252-6. doi: 10.4103/0973-029X.86669.

Reference Type BACKGROUND
PMID: 22144824 (View on PubMed)

Hamdy AA, Ibrahem MA. Management of aphthous ulceration with topical quercetin: a randomized clinical trial. J Contemp Dent Pract. 2010 Jul 1;11(4):E009-16.

Reference Type BACKGROUND
PMID: 20953559 (View on PubMed)

Other Identifiers

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1990

Identifier Type: -

Identifier Source: org_study_id

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