Excessive Gingival DisplayNCT06944535
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
An observational study of Excessive Gingival Display, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Excessive Gingival Display
- What is being tested?
- Modified Lip Repositioning Surgery (Retrospective)
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteVietnam
- Study dates
- 12 Sep 2023to 20 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Excessive Gingival Display
- Being tested
- Modified Lip Repositioning Surgery (Retrospective)
- Keywords
- Excessive gingival display, gummy smile, ip repositioning surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Lip Repositioning Surgery (Retrospective)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Modified Lip Repositioning Surgery (Retrospective) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start12 Sep 2023
- Primary completion12 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive Gingival DisplayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lam N Le, PhD, Principal investigator, Can Tho University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944535
- Sponsor's protocol ID
- Le Nguyen Lam
- Status last verified
- Sep 2023
- First submitted
- 7 Apr 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29193632
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06944535
- Acronym / sponsor ID
- Le Nguyen Lam
- Conditions
- Excessive Gingival Display
- Keywords
- Excessive gingival display, gummy smile, ip repositioning surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Lip Repositioning Surgery (Retrospective Cohort) | – | Procedure: Modified Lip Repositioning Surgery (Retrospective)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Lip Repositioning Surgery (Retrospective)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. | Procedure or surgery | Modified Lip Repositioning Surgery (Retrospective Cohort) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 29193632Tawfik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lam N Le, PhD principal investigator
Can Tho University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Gingival Display, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in gingival display after modified lip repositioning surgery (time frame: Baseline and up to 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.