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Status unknownNCT03213769Updated Jul 11, 2017

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

An interventional study of topical coenzyme Q10 gel and Carpabol gel in Oral Aphthous Ulcer, sponsored by Cairo University. Status unknown. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Oral Aphthous Ulcer

Keywords

  • oral minor aphthous ulcer
  • topical Q10 gel
  • topical antioxidant
  • oral recurrent aphthous ulcer
  • oral aphthous stomatitis
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    carbapol gel

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

    Drug: Carpabol gel

Interventions

  • Drugtopical coenzyme Q10 gel

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

  • DrugCarpabol gel

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

05

What researchers measure

Primary outcomes

  1. visual analogue scale

    pain

    Time frame: 7 days

Secondary outcomes

  1. scoring system(0-3)

    Erythema surround lesion

    Time frame: 7 days

  2. cross sectional area William periodontal probe/mm

    Cross sectional area

    Time frame: 7 days

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 20569032 ↗
  • 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. PubMed 16155535 ↗
  • 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. PubMed 20173724 ↗
  • 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. PubMed 17914161 ↗
  • 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. PubMed 26028911 ↗
  • 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. PubMed 21189900 ↗
  • 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. PubMed 22144824 ↗
  • 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. PubMed 20953559 ↗
08

Registry details

Key details

Study ID
NCT03213769
Lead sponsor
Cairo University
Responsible party
Mostafa Abdelsamie Bakry Nafie (Principal investigator, Cairo University) — Principal investigator
First posted
Jul 11, 2017
Start date
Jul 2017 (estimated)
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Jul 11, 2017

Study contacts

mostafa abdelsamie nafie, master
Contact
mostafa.abdelsamie@dentistry.cu.edu.eg
+201004165905
Amal Ali, lecturer
Contact
amal_ali.2009@yahoo.com
+201005204628
fatheya zahran, professor
study director · faculty of dentistry -CairoU

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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