Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-06 @ 6:06 PM
Study NCT ID:
NCT03213769
Status:
UNKNOWN
Last Update Posted:
2017-07-11
First Post:
2017-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005536', 'term': 'Foot-and-Mouth Disease'}], 'ancestors': [{'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000820', 'term': 'Animal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'controlled randimized clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-10', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale', 'timeFrame': '7 days', 'description': 'pain'}], 'secondaryOutcomes': [{'measure': 'scoring system(0-3)', 'timeFrame': '7 days', 'description': 'Erythema surround lesion'}, {'measure': 'cross sectional area William periodontal probe/mm', 'timeFrame': '7 days', 'description': 'Cross sectional area'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral minor aphthous ulcer', 'topical Q10 gel', 'topical antioxidant', 'oral recurrent aphthous ulcer', 'oral aphthous stomatitis'], 'conditions': ['Oral Aphthous Ulcer']}, 'referencesModule': {'references': [{'pmid': '20569032', 'type': 'BACKGROUND', '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.'}, {'pmid': '16155535', 'type': 'BACKGROUND', '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.'}, {'pmid': '20173724', 'type': 'BACKGROUND', '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.'}, {'pmid': '17914161', 'type': 'BACKGROUND', '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.'}, {'pmid': '26028911', 'type': 'BACKGROUND', '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.'}, {'pmid': '21189900', 'type': 'BACKGROUND', '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.'}, {'pmid': '22144824', 'type': 'BACKGROUND', '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.'}, {'pmid': '20953559', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSample size of study include 26 in each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with free medical history and no systemic diseases16.\n* Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers.\n* Patients who agreed to take medications.\n\nExclusion Criteria:\n\n* Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others.\n* Anemic and leukemic patients (using complete blood count investigation)\n* Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy.\n* Patients treated with any oral topical medications 48h before the study27.\n* Pregnant and lactating mothers."}, 'identificationModule': {'nctId': 'NCT03213769', 'briefTitle': 'Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer', 'orgStudyIdInfo': {'id': '1990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'topical coenzyme Q10 gel', 'description': 'Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.', 'interventionNames': ['Drug: topical coenzyme Q10 gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'carbapol gel', 'description': 'placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.', 'interventionNames': ['Drug: Carpabol gel']}], 'interventions': [{'name': 'topical coenzyme Q10 gel', 'type': 'DRUG', 'description': 'Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.', 'armGroupLabels': ['topical coenzyme Q10 gel']}, {'name': 'Carpabol gel', 'type': 'DRUG', 'description': 'placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.', 'armGroupLabels': ['carbapol gel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mostafa abdelsamie nafie, master', 'role': 'CONTACT', 'email': 'mostafa.abdelsamie@dentistry.cu.edu.eg', 'phone': '+201004165905'}, {'name': 'Amal Ali, lecturer', 'role': 'CONTACT', 'email': 'amal_ali.2009@yahoo.com', 'phone': '+201005204628'}], 'overallOfficials': [{'name': 'fatheya zahran, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of dentistry -CairoU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mostafa Abdelsamie Bakry Nafie', 'investigatorAffiliation': 'Cairo University'}}}}