NCT06944535

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

April 7, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

Excessive gingival displaygummy smileip repositioning surgery

Outcome Measures

Primary Outcomes (1)

  • Reduction in gingival display after modified lip repositioning 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

Study Arms (1)

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.

Procedure: Modified Lip Repositioning Surgery (Retrospective)

Interventions

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.

Modified Lip Repositioning Surgery (Retrospective Cohort)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Can Tho University of Medicine and Pharmacy

Can Tho, 900000, Vietnam

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Retrospective Studies

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lam N Le, PhD

    Can Tho University of Medicine and Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 25, 2025

Study Start

September 12, 2023

Primary Completion

September 12, 2024

Study Completion

September 20, 2024

Last Updated

September 19, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations