Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT06452134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024989', 'term': 'coenzyme Q10'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D014451', 'term': 'Ubiquinone'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Tissue healing', 'timeFrame': '1, 7, 14 and 30 days after surgery', 'description': 'Regeneration-the replacement of damaged tissues with cells of the same type-and fibrosis-the replacement of damaged tissues with connective tissue-are the two primary processes involved in wound healing. To help in tissue healing, some cells, such as fibroblasts and vascular endothelial cells, have the ability to proliferate quickly in response to an external stimulation. Wound closure also requires non-proliferating cells, such as peripheral nervous system cells and odontoblasts. The bone that grows in to fill the space left by a tooth extraction should be similar to the surrounding healthy tissues. A lack of tissue healing is indicated by symptoms such as edema, fever, bleeding, discomfort, necrosis, exudate, flap instability, foul taste, and fistula. If trismus results from a muscle injury following an IAN Block injection, it should go away as the tissue heals.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Temporomandibular disorders', 'timeFrame': '1, 7, 14 and 30 days after surgery', 'description': "Temporomandibular disorders is a collective term for a set of disorders characterized by pain and dysfunction in the muscles and jaw joint. A specialist dentist will measure a patient's temporomandibular disorder (TMD) clinically by looking for signs of trismus, abnormal movement of the lower jaw during opening and closing or chewing, jaw dysfunction, reduced range of motion, ear pain, temporal pain, headache, bruxism, sensitivity of the muscles in the neck and shoulders, and malocclusion (such as acquired edentulism, facial asymmetry, etc.). The diagnosis of TMD is finalized if the symptoms are positive."}, {'measure': 'Occurrence of Dry socket', 'timeFrame': '1, 7, 14 and 30 days after surgery', 'description': "This is a non-scientific phrase for a cavity where all or part of the bone is exposed since there isn't any bone in the days following extraction. This can happen inside the cavity or outside the occlusal environment of the cavity. Severe recurrent pain results from the patient's inability to stop the mechanical stimulation of food particles or tongue on the exposed bone, which is extremely painful to touch. A specialized physician measures it by doing a clinical examination as well as by observing the whiteness of the bone-which is empty and uncomfortable to the touch-in the extracted tooth's socket."}, {'measure': 'Answers to The Short Form Health Survey-36', 'timeFrame': '1, 7, 14 and 30 days after surgery', 'description': "This tool has shown to be useful in a variety of contexts, including clinical practice, the assessment of health policies, and general security investigations. The 36-item form was created in the United States in 1992 by Ware and associates, and studies on a range of patient populations have assessed its validity and reliability. This questionnaire's topics are not restricted to any one age range, illness, or condition. By adding the results of the eight health-forming categories, the questionnaire's design aims to assess the state of health from both a physical and mental standpoint. This survey, which consists of 63 items, rates eight distinct health domains using a scoring system derived from the table found in the reference. To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better health status."}, {'measure': 'Answers to The General Health Questionnaire-12', 'timeFrame': '1, 7, 14 and 30 days after surgery', 'description': 'Developed in the 1970s, the General Health Questionnaire (GHQ) is regarded as a valid and dependable instrument for evaluating mental health. The most popular of the various iterations of this survey is the GHQ-12 version. It is a 12-item mental health assessment that is assessed using the table given in the reference.The scores typically used are the binary scale (0-0-1-1) and the 4-point Likert-type scale (0-1-2-3). Responses to all items are summed up to a total score ranging from 0 to 12 (binary scale) or 0 to 36 (Likert scale), with higher scores indicating more severe impairment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coenzyme Q10', 'Dry Socket', 'Temporomandibular Joint Disorders', 'Molar, Third', 'SF-36 health survey', 'Tissue healing', 'Tooth Extraction', 'GHQ-12'], 'conditions': ['Molar, Third', 'Temporomandibular Joint Disorders', 'Dry Socket', 'Coenzyme Q10']}, 'referencesModule': {'references': [{'pmid': '26070801', 'type': 'RESULT', 'citation': 'Rafetto LK. Managing Impacted Third Molars. Oral Maxillofac Surg Clin North Am. 2015 Aug;27(3):363-71. doi: 10.1016/j.coms.2015.04.004. Epub 2015 Jun 9.'}, {'pmid': '26614696', 'type': 'RESULT', 'citation': 'Glickman A, Karlis V. Pediatric Benign Soft Tissue Oral and Maxillofacial Pathology. Oral Maxillofac Surg Clin North Am. 2016 Feb;28(1):1-10. doi: 10.1016/j.coms.2015.07.005.'}, {'pmid': '31735229', 'type': 'RESULT', 'citation': 'Kaner KH. Referral and Management Considerations for a Biopsy: Why Choose the Oral and Maxillofacial Surgeon. Dent Clin North Am. 2020 Jan;64(1):241-247. doi: 10.1016/j.cden.2019.08.013. Epub 2019 Oct 21.'}, {'pmid': '33789003', 'type': 'RESULT', 'citation': 'Kiencalo A, Jamka-Kasprzyk M, Panas M, Wyszynska-Pawelec G. Analysis of complications after the removal of 339 third molars. Dent Med Probl. 2021 Jan-Mar;58(1):75-80. doi: 10.17219/dmp/127028.'}, {'pmid': '36147052', 'type': 'RESULT', 'citation': 'Hallab L, Azzouzi A, Chami B. Quality of life after extraction of mandibular wisdom teeth: A systematic review. Ann Med Surg (Lond). 2022 Aug 21;81:104387. doi: 10.1016/j.amsu.2022.104387. eCollection 2022 Sep.'}, {'pmid': '36353739', 'type': 'RESULT', 'citation': 'Hao M, Duan M, Yang Z, Zhou H, Li S, Xiang J, Wu H, Liu H, Chang L, Wang D, Liu W. Engineered stem cell exosomes for oral and maxillofacial wound healing. Front Bioeng Biotechnol. 2022 Oct 24;10:1038261. doi: 10.3389/fbioe.2022.1038261. eCollection 2022.'}, {'pmid': '17935805', 'type': 'RESULT', 'citation': 'Cluis CP, Burja AM, Martin VJ. Current prospects for the production of coenzyme Q10 in microbes. Trends Biotechnol. 2007 Nov;25(11):514-21. doi: 10.1016/j.tibtech.2007.08.008.'}, {'pmid': '22252298', 'type': 'RESULT', 'citation': 'Moon HJ, Ko WK, Han SW, Kim DS, Hwang YS, Park HK, Kwon IK. Antioxidants, like coenzyme Q10, selenite, and curcumin, inhibited osteoclast differentiation by suppressing reactive oxygen species generation. Biochem Biophys Res Commun. 2012 Feb 10;418(2):247-53. doi: 10.1016/j.bbrc.2012.01.005. 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Br J Math Stat Psychol. 2001 May;54(Pt 1):1-20. doi: 10.1348/000711001159357.'}, {'pmid': '40616597', 'type': 'DERIVED', 'citation': 'Nejati Z, Ghadirzadeh B, Mohammadi H, Afraie M, Moradi Y. Effect of coenzyme Q10 on post-extraction tissue healing in wisdom tooth Surgery: double-blind randomized clinical trial. Pain Manag. 2025 Sep;15(9):555-569. doi: 10.1080/17581869.2025.2528590. Epub 2025 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to asses the effect of Coenzyme Q10 administration in patients from any gender group who are older than 18 years old undergoing wisdom tooth extraction. The main questions it aims to answer are:\n\ndoes Coenzyme Q10 help with better tissue healing? does Coenzyme Q10 administration lower the prevalence of Dry socket after surgery? does Coenzyme Q10 prevent TMD (Temporomandibular disorders) while recovering from surgery? how does Coenzyme Q10 administration effect the answers to SF-36 health survey in patients? Researchers will compare Coenzyme Q10 to a placebo (a look-alike substance that contains no drug) to see if it has any effect on mentioned parameters.\n\nParticipants will:\n\n* take coenzyme Q10 (100mg) daily for 30 days after surgery.\n* will be examined and evaluated 1, 7, 14 and 30 days after completion of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients older than 18 years old that require mandibular or maxillary molar, third tooth extraction as Oral and Maxillofacial surgeon's clinical diagnosis.\n\nExclusion Criteria:\n\n* The patient's departure from Sanandaj\n* The patient's disagreement with the study protocol\n* The Patient's demise\n* The patient's hospitalization for unrelated illnesses\n* The patient's discontent with the care they received\n* The patient's failure to show up for follow-up appointments\n* The patient's sensitivity to Coenzyme Q10"}, 'identificationModule': {'nctId': 'NCT06452134', 'briefTitle': 'Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction', 'organization': {'class': 'OTHER', 'fullName': 'Kurdistan University of Medical Sciences'}, 'officialTitle': 'Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction in the City of Sanandaj-Iran in 1402: a Double-blinded Clinical Trial Study', 'orgStudyIdInfo': {'id': 'IR.MUK.REC.1403.030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'This arm of the study includes 35 of participants who will be given Coenzyme Q10 100 MG Oral Tablet for 30 days.', 'interventionNames': ['Drug: Coenzyme Q10 100 MG Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'This arm of the study includes 35 of participants who will be given Placebo ( a look-alike substance ) with same tablet form given daily for a period of 30 days after surgery.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Coenzyme Q10 100 MG Oral Tablet', 'type': 'DRUG', 'otherNames': ['Coenzyme Q', 'CoQ', 'CoQ10', 'Ubiquinone', 'Ubiquinone-Q10', 'Ubidecarenone', 'Vitamin Q10'], 'description': 'Coenzyme Q10 oral Tablet with dosage of 100mg daily given for a period of 30 days after surgery.', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Exactly same looking agent in the form of a tablet with same size and color to CoezymeQ10 with no active property given for a period of 30 days after surgery.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zahra Nejati', 'role': 'CONTACT', 'email': 'Znregina@gmail.com', 'phone': '+989220243892'}, {'name': 'Babak Ghadirzadeh', 'role': 'CONTACT', 'email': 'Ghadirzadeh.babak@gmail.com', 'phone': '+989355795670'}], 'overallOfficials': [{'name': 'Zahra Nejati', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zahra Nejati, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zahra Nejati', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kurdistan University of Medical Sciences', 'class': 'OTHER'}, {'name': 'Hady Mohammadi, Director of oral and maxillofacial surgery department, school of dentistry, Kurdistan university of medical sciences', 'class': 'UNKNOWN'}, {'name': 'Yousef Moradi, Assistant professor, Department of epidemiology and biostatistics, Kurdistan university of medical sciences', 'class': 'UNKNOWN'}, {'name': 'Babak Ghadirzadeh, medical student, Kurdistan university of medical sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Zahra Nejati, Dental student, Department of oral and maxillofacial medicine, School of Dentistry, Kurdistan University of Medical Sciences, Sanandaj, Iran.', 'investigatorFullName': 'Zahra Nejati', 'investigatorAffiliation': 'Kurdistan University of Medical Sciences'}}}}