Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-01-02 @ 2:03 AM
Study NCT ID:
NCT06944535
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Modified Lip Repositioning Surgery Technique With Tie Levator Labii Superioris and Without Frenectomy and Myotomy for Treatment of Excessive Gingival Display: A Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012189', 'term': 'Retrospective Studies'}], 'ancestors': [{'id': 'D016022', 'term': 'Case-Control Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in gingival display after modified lip repositioning surgery', 'timeFrame': 'Baseline and up to 12 months post-surgery', 'description': 'Measurement of gingival display (in millimeters) on smile, comparing baseline (before surgery) and last available follow-up (after surgery), based on clinical photographs and medical records.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Excessive gingival display', 'gummy smile', 'ip repositioning surgery'], 'conditions': ['Excessive Gingival Display']}, 'referencesModule': {'references': [{'pmid': '29193632', 'type': 'RESULT', 'citation': 'Tawfik OK, El-Nahass HE, Shipman P, Looney SW, Cutler CW, Brunner M. Lip repositioning for the treatment of excess gingival display: A systematic review. J Esthet Restor Dent. 2018 Mar;30(2):101-112. doi: 10.1111/jerd.12352. Epub 2017 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'This retrospective study aims to evaluate the effectiveness and safety of a modified lip repositioning surgery technique, performed without frenectomy and without myotomy, for the correction of excessive gingival display ("gummy smile"). Data were collected from the medical records and clinical photographs of patients who had previously undergone this surgical procedure at the study site.', 'detailedDescription': 'Excessive gingival display, commonly referred to as a "gummy smile," is an esthetic concern that may reduce patient satisfaction with their smile and overall facial appearance. Several treatment modalities have been suggested to address this condition, including orthodontic treatment, botulinum toxin injection, and various surgical techniques. Among surgical approaches, lip repositioning surgery has gained popularity due to its minimally invasive nature and ability to provide predictable esthetic outcomes.\n\nA modified lip repositioning technique, performed without frenectomy and without myotomy, has been introduced to reduce morbidity and simplify the procedure while maintaining effectiveness. However, published evidence has largely come from prospective interventional series.\n\nTo further evaluate the clinical performance of this modified technique, we conducted a retrospective observational cohort study. Data were obtained from the medical records and clinical photographs of patients who had previously undergone the modified lip repositioning surgery at the study site. No new patients were enrolled and no interventions were prospectively carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had previously undergone modified lip repositioning surgery without frenectomy and without myotomy for the correction of excessive gingival display.\n\nData were collected retrospectively from medical records and clinical photographs of eligible patients treated at the study site during the defined study period.\n\nOnly patients with complete documentation before and after surgery were included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with the modified lip repositioning surgery without frenectomy and without myotomy.\n* Complete medical records including pre- and post-operative documentation.\n* Clinical photographs available before and after surgery.\n* Minimum follow-up period documented (≥ 3 months).\n\nExclusion Criteria:\n\n* The patient has trauma and facial deformities\n* Incomplete medical records or missing photographs.\n* Patients lost to follow-up before minimum period.\n* Patients who had undergone other concurrent surgical/orthodontic procedures affecting gingival display.'}, 'identificationModule': {'nctId': 'NCT06944535', 'briefTitle': 'Efficacy of a Modified Lip Repositioning Surgery Technique With Tie Levator Labii Superioris and Without Frenectomy and Myotomy for Treatment of Excessive Gingival Display: A Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Can Tho University of Medicine and Pharmacy'}, 'officialTitle': 'Efficacy of a Modified Lip Repositioning Surgery Technique With Tie Levator Labii Superioris and Without Frenectomy and Myotomy for Treatment of Excessive Gingival Display: A Retrospective Study', 'orgStudyIdInfo': {'id': 'Le Nguyen Lam'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Modified Lip Repositioning Surgery (Retrospective Cohort)', 'description': 'This cohort includes patients who had previously undergone the modified lip repositioning surgery technique without frenectomy and without myotomy. Data were obtained retrospectively from medical records and clinical photographs. No prospective intervention was performed.', 'interventionNames': ['Procedure: Modified Lip Repositioning Surgery (Retrospective)']}], 'interventions': [{'name': 'Modified Lip Repositioning Surgery (Retrospective)', 'type': 'PROCEDURE', 'description': 'Patients previously underwent a modified lip repositioning surgery technique without frenectomy and without myotomy. For this retrospective study, only existing medical records and clinical photographs were reviewed. No new surgical intervention was performed.', 'armGroupLabels': ['Modified Lip Repositioning Surgery (Retrospective Cohort)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '900000', 'city': 'Can Tho', 'country': 'Vietnam', 'facility': 'Can Tho University of Medicine and Pharmacy', 'geoPoint': {'lat': 10.03711, 'lon': 105.78825}}], 'overallOfficials': [{'name': 'Lam N Le, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Can Tho University of Medicine and Pharmacy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Can Tho University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}