- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06944535
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
A 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.
To 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Can Tho, Vietnam, 900000
- Can Tho University of Medicine and Pharmacy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients who had previously undergone modified lip repositioning surgery without frenectomy and without myotomy for the correction of excessive gingival display.
Data were collected retrospectively from medical records and clinical photographs of eligible patients treated at the study site during the defined study period.
Only patients with complete documentation before and after surgery were included.
Description
Inclusion Criteria:
- Patients treated with the modified lip repositioning surgery without frenectomy and without myotomy.
- Complete medical records including pre- and post-operative documentation.
- Clinical photographs available before and after surgery.
- Minimum follow-up period documented (≥ 3 months).
Exclusion Criteria:
- The patient has trauma and facial deformities
- Incomplete medical records or missing photographs.
- Patients lost to follow-up before minimum period.
- Patients who had undergone other concurrent surgical/orthodontic procedures affecting gingival display.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Modified Lip Repositioning Surgery (Retrospective Cohort)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in gingival display after modified lip repositioning surgery
Time Frame: Baseline and up to 12 months post-surgery
|
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.
|
Baseline and up to 12 months post-surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Lam N Le, PhD, Can Tho University of Medicine and Pharmacy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Epidemiologic Studies
- Epidemiologic Study Characteristics
- Cohort Studies
- Case-Control Studies
- Retrospective Studies
Other Study ID Numbers
- Le Nguyen Lam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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