Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-08 @ 10:34 PM
Study NCT ID:
NCT06075134
Status:
UNKNOWN
Last Update Posted:
2023-10-10
First Post:
2023-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D004576', 'term': 'Electromyography'}], 'ancestors': [{'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009213', 'term': 'Myography'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in amount of gingival display', 'timeFrame': 'Baseline, One-week, One-month, three-months, and six-months follow-up', 'description': 'Will be measured using ruler in mm.'}], 'secondaryOutcomes': [{'measure': 'Quantitative EMG', 'timeFrame': 'Baseline, One-week and six-months follow-up', 'description': 'Will be measured using EMG in mv.'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Baseline, One-week, One-month, three-months, and six-months follow-up', 'description': 'Will be assessed using questionnaire, on a scale from 1 to 5, where 1 is completely not satisfied and 5 is completely satisfied.'}, {'measure': 'Post-operative pain', 'timeFrame': 'Baseline, One-week, and One-month follow-up', 'description': 'Will be measured using visual analogue scale (VAS) from 1 to 10.'}, {'measure': 'Smile type', 'timeFrame': 'Baseline, One-week, One-month, three-months, and six-months follow-up', 'description': 'Qualitative, by Rubin (1974). Smile is classified into 1. Corner of the mouth (Mona Lisa) smile, 2. Canine Smile, and 3. Full denture smile'}, {'measure': 'Change in lip length', 'timeFrame': 'Baseline, One-week, One-month, three-months, and six-months follow-up', 'description': 'Will be measured using UNC (University of North Carolina) -15 periodontal probe in mm.'}, {'measure': 'Esthetics (Symmetry) for operators', 'timeFrame': 'Baseline, One-week, One-month, three-months, and six-months follow-up', 'description': 'Will be measured using 5-point Likert scale, where 1 is significantly asymmetrical and 5 is completely symmetrical.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Excessive Gingival Display']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effect of EMG-guided Botox injection with conventional Botox injection in Yonsei point, in patients with excessive gingival display.\n\nThe main question it aims to answer is:\n\n• Does the use of electromyography (EMG) as a guide during Botox injection for patients with gummy smile has better effect than conventional injection in Yonsei point?\n\nParticipants will be randomized in equal proportions between intervention and control groups.\n\n* Preoperative assessment of amount of gingival display, lip length (philtrum and vermilion length), and smile type.\n* For the intervention group, EMG readings will be done in Clinical Neurophysiology Department, Kasr Al-Ainy Hospital EMG-guided Botox injection (Intervention group). Conventional Botox injection in Yonsei point (Control group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with excessive gingival display.\n* Patients with esthetic concerns.\n* Patients with mild to moderate VME (vertical maxillary excess).\n* Normal clinical crown dimensions.\n* Patients aged 18 to 50.\n* Systemically healthy patients.\n* Non-smokers.\n\nExclusion Criteria:\n\n* Patients with severe VME (vertical maxillary excess).\n* Pregnant and breastfeeding women.\n* Patients with gingival inflammation and/or enlargement.\n* Inflammation or infection at the site of injection.\n* Patients with known allergy to any of the components of Botox (i.e., saline, human albumin, lactose and sodium succinate).\n* Patients using anticholinesterase or other agents affecting neuromuscular transmission.\n* Psychologically unstable patients or those who have unrealistic expectations and questionable motives.\n* Patients with neuromuscular disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome).'}, 'identificationModule': {'nctId': 'NCT06075134', 'briefTitle': 'EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'EMG-guided Botox Injection Versus Conventional Injection in Yonsei Point in Gummy Smile Patients: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SFAkhnokh'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EMG-guided Botox injection', 'description': 'Botox injection in patients with gummy smile will be done under electromyography guidance to target the most hyperactive and effective muscle that is the chief factor causing the condition.', 'interventionNames': ['Procedure: Botox injection', 'Device: EMG', 'Drug: Zinc Supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Botox injection in Yonsei point', 'description': 'Conventional injection of Botox is located in Yonsei point, which is the center of a triangle formed by the convergence of Levator labii superioris alaeque nasi (LLSAN), levator labii superioris (LLS), zygomaticus minor (ZMn), muscles, and is located 1 cm lateral to the ala of the nose horizontally and 3 cm above the lip line vertically.', 'interventionNames': ['Procedure: Botox injection', 'Drug: Zinc Supplement']}], 'interventions': [{'name': 'Botox injection', 'type': 'PROCEDURE', 'otherNames': ['Botulinum toxin injection'], 'description': 'Botox injection', 'armGroupLabels': ['Conventional Botox injection in Yonsei point', 'EMG-guided Botox injection']}, {'name': 'EMG', 'type': 'DEVICE', 'otherNames': ['Electromyography'], 'description': 'Quantitative Electromyography', 'armGroupLabels': ['EMG-guided Botox injection']}, {'name': 'Zinc Supplement', 'type': 'DRUG', 'otherNames': ['Zinc supplement in the form of tablets'], 'description': 'To increase efficacy of Botox', 'armGroupLabels': ['Conventional Botox injection in Yonsei point', 'EMG-guided Botox injection']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sherry Fayez Akhnokh, BSc', 'role': 'CONTACT', 'email': 'sherry.akhnokh@dentistry.cu.edu.eg', 'phone': '+0201284857175'}, {'name': 'Nesma Shemais, PhD', 'role': 'CONTACT', 'email': 'nesma.shemais@dentistry.cu.edu.eg'}], 'overallOfficials': [{'name': 'Sherry Fayez Akhnokh, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}, {'name': 'Noha Ghallab, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Nesma Shemais, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Periodontology Resident', 'investigatorFullName': 'Sherry Fayez Akhnokh', 'investigatorAffiliation': 'Cairo University'}}}}