Back to resultsClinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
Primary Purpose
Oral Aphthous Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
topical coenzyme Q10 gel
Carpabol gel
Sponsored by
About this trial
This is an interventional treatment trial for Oral Aphthous Ulcer focused on measuring oral minor aphthous ulcer, topical Q10 gel, topical antioxidant, oral recurrent aphthous ulcer, oral aphthous stomatitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
topical coenzyme Q10 gel
carbapol gel
Arm Description
Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.
Outcomes
Primary Outcome Measures
visual analogue scale
pain
Secondary Outcome Measures
scoring system(0-3)
Erythema surround lesion
cross sectional area William periodontal probe/mm
Cross sectional area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03213769
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Aphthous Ulcer
Keywords
oral minor aphthous ulcer, topical Q10 gel, topical antioxidant, oral recurrent aphthous ulcer, oral aphthous stomatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
controlled randimized clinical trial
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
topical coenzyme Q10 gel
Arm Type
Active Comparator
Arm Description
Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
Arm Title
carbapol gel
Arm Type
Placebo Comparator
Arm Description
placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.
Intervention Type
Drug
Intervention Name(s)
topical coenzyme Q10 gel
Intervention Description
Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
Intervention Type
Drug
Intervention Name(s)
Carpabol gel
Intervention Description
placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.
Primary Outcome Measure Information:
Title
visual analogue scale
Description
pain
Time Frame
7 days
Secondary Outcome Measure Information:
Title
scoring system(0-3)
Description
Erythema surround lesion
Time Frame
7 days
Title
cross sectional area William periodontal probe/mm
Description
Cross sectional area
Time Frame
7 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa abdelsamie nafie, master
Phone
+201004165905
Email
mostafa.abdelsamie@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Ali, lecturer
Phone
+201005204628
Email
amal_ali.2009@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatheya zahran, professor
Organizational Affiliation
faculty of dentistry -CairoU
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
20569032
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.
Results Reference
background
PubMed Identifier
16155535
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.
Results Reference
background
PubMed Identifier
20173724
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.
Results Reference
background
PubMed Identifier
17914161
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.
Results Reference
background
PubMed Identifier
26028911
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.
Results Reference
background
PubMed Identifier
21189900
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.
Results Reference
background
PubMed Identifier
22144824
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.
Results Reference
background
PubMed Identifier
20953559
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.
Results Reference
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Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
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