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

Oral Aphthous Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03213769
• Other study ID #: 1990
• Status: Not yet recruiting
• Phase: N/A
• First received: July 5, 2017
• Last updated: July 10, 2017
• Start date: July 2017
• Est. completion date: July 2018

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: mostafa abdelsamie nafie, master
• Phone: +201004165905
• Email: mostafa.abdelsamie[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Aphthous Ulcer
• Stomatitis, Aphthous
• Ulcer

Intervention

Drug:
• topical coenzyme Q10 gel
Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
• Carpabol gel
placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (8)

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. — View Citation

Littarru GP, Tiano L. Bioenergetic and antioxidant properties of coenzyme Q10: recent developments. Mol Biotechnol. 2007 Sep;37(1):31-7. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	pain	7 days
Secondary	scoring system(0-3)	Erythema surround lesion	7 days
Secondary	cross sectional area William periodontal probe/mm	Cross sectional area	7 days