Clinical trial NCT03213769: Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
Official title: Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Aphthous Ulcer
Keywords: oral minor aphthous ulcer
topical Q10 gel
topical antioxidant
oral recurrent aphthous ulcer
oral aphthous stomatitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled randimized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: visual analogue scale
timeFrame: 7 days
Secondary outcomes:
measure: scoring system(0-3)
timeFrame: 7 days
measure: cross sectional area William periodontal probe/mm
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: faculty of dentistry -CairoU
name: fatheya zahran, professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.