Gummy Smile Due to Hypermobile Upper LipNCT07285343
Comparison Between Lip Repositioning and Muscle Traction Technique in Treatment of Gummy Smile
A study testing lip repositioning and Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique in people with Gummy Smile Due to Hypermobile Upper Lip and Excessive Gingival Display, run by Suez Canal University at 2 sites in Egypt.
Trial summary
The goal of this clinical trial is to compare and evaluate the effectiveness of conventional and modified lip repositioning for the treatment of gummy smile. The main question it aims to answer: Which of these treatment modalities (conventional lip repositioning and containment of the elevator muscle of the upper lip… Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Gummy Smile Due to Hypermobile Upper Lip, Excessive Gingival Display
- What is being tested?
- lip repositioning and Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Interventional
- 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 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged between 18 and 38 years.
- Gummy smile ranging between 4 and 6 mm, due to short upper lip and hyperactive lip elevator muscles (lip mobility >8 mm).
- Good periodontal health based on the examination of the gingival inflammation index, bleeding index, and probing the depth of gingival pockets.
- Healthy patients or people with well-controlled systemic disease.
Who cannot join
- Smokers.
- Pregnant or lactating women.
- Less than 3 mm of attached gingiva that might create difficulties in flap design, stabilization, and suturing.
- Vertical maxillary excess of more than 6 mm.
- Poorly controlled systemic diseases that preclude local anesthesia.
- Altered passive eruption, which needs gingivectomy or an apically positioned flap.
- Skeletal causes of gummy smile as protruded maxilla.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Periodontology Clinic in Suez Canal University
Cairo, Egypt, 1234
Periodontology Clinic in Suez Canal University
Ismailia, Ismailia Governorate, 1234
About this study
Official title: Controlled Randomized Clinical Trial of Containment of the Elevator Muscle of Upper Lip and Wing of Nose Technique Versus Conventional Lip Repositioning for Treatment of Gummy Smile
The goal of this clinical trial is to compare and evaluate the effectiveness of conventional and modified lip repositioning for the treatment of gummy smile.
The main question it aims to answer:
Read more
Which of these treatment modalities (conventional lip repositioning and containment of the elevator muscle of the upper lip and wing of nose (EMULWN)) has the most durable and least relapse in the treatment of gummy smile?"
Researchers will compare:
- The primary outcome was the decrease in excessive gingival display by measuring smile line (gingival display) and smile index before and after treatment modalities.
- The The secondary outcome was to measure the durability and possibility of relapse over 6 months after treatment with high patient satisfaction.
Read the detailed description
For patients seeking long-term correction of excessive gingival displays, there are different treatment modalities. Both lip repositioning and muscle traction techniques showed improvement in the decrease in the amount of gingival display, while the containment surgery of the muscle of the upper lip and wing of the nose showed durable and satisfactory esthetics with less patient discomfort and less pain immediately after the procedure and needs more time to study or may need some modification. Also, lip repositioning showed satisfactory results to the patients but with more pain immediately after the procedure.
- Being tested
- lip repositioning, Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique
- Keywords
- Gummy Smile, Patient Discomfort, Patient Satisfaction, Gingival Display, Smile Line, Smile index, lip repositioning, muscle traction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lip repositioningProcedure or surgery
Local anesthesia was administered in the vestibular mucosa. A partial-thickness incision was made at the mucogingival junction from the mesial line angle of the right first molar to the mesial line angle of the left first molar. A second partial- thickness incision, parallel to the first, was made in the labial mucosa, 10 to 12 mm apical to the mucogingival junction. The incisions were connected at each first molar, creating an elliptical outline. The epithelium was removed within the outline of the incisions, leaving the underlying connective tissue exposed. Care was taken to avoid damage to any minor salivary glands in the submucosa. The parallel incision lines were approximated with interrupted stabilization sutures at the midline and other locations along the borders of the incision to ensure proper alignment of the lip midline with the midline of the teeth. Then, a continuous interlocking suture was used to approximate both flap ends.
Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) techniqueProcedure or surgery
Local anesthesia was administered in the vestibular mucosa and lip then a vertical incision was made on the labial frenum, and two more horizontal incisions were made on the mucogingival line, starting from the frenum incision up to the height of the canines. The flap was carefully divulsed with Goldman Fox scissors and also a curved hemostat, separating the external epithelium from the muscle bundle mucosa on both sides at the height of the lateral incisors and canines. With an absorbable suture thread, the elevator muscle of the upper lip and wing of the nose was pulled downwards, repositioning its bundle nearer the highest portion of the keratinized gingiva. Simple sutures were made, as many as necessary, in order to contain the pulled muscle in this position. The procedure ended up with a continuous suture in the labial frenum and in the horizontal incisions with the use of a 4-0 silk suture thread. The external stitches should be removed in 10-15 days" time.
| Study group | Role | What they receive |
|---|---|---|
| lip repositioning | Active comparator | lip repositioning to treat excessive gingival display Receives: Procedure: lip repositioning |
| Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) | Active comparator | Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique in treatment of excessive gingival display Receives: Procedure: Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring smile line (the amount of gingival display in millimeters)
The first primary outcome of the study was to measure the change in excessive gingival display by measuring smile line (the amount of gingival display in millimeters) before and after treatment.
1/Smile line (gingival display) Type 1: Very high smile line: 2 mm or more of marginal and attached gingiva visible or more than 2 mm of root or gingiva apical to the cemento-enamel junction visible for the healthy but reduced periodontium. This smile is classified as a "gummy smile." Type 2: High smile line: Between 0 and 2 mm of marginal and attached gingiva visible or between 0 and 2 mm visibility of root and gingiva apical to the cemento-enamel junction visible for the reduced and healthy periodontium.
Type 3: Average smile line: Gingival embrasures only visible. Type 4: Low smile line: Gingival embrasure and cemento-enamel junction not visible.
Measured: at baseline, after one month, after 3 months and after 6 months
Measuring smile index ratio before and after treatment.
The second primary outcome of the study was to measure the change in excessive gingival display by measuring smile index ratio which is (intercommissural width/interlabial gap) to visualize and quantify the frontal smile. The ratio is used for comparing smiles among patients. The lower the smile index, the less youthful the smile appears.
Measured: at baseline, after one month, after 3 months and after 6 months
Secondary outcomes (2)
Patient Satisfaction with Their Smile
Patient satisfaction with their smile was recorded on the following scale: 0 (very satisfied); 1 (satisfied); 2 (moderately satisfied); 3 (unsatisfied).
Measured: at baseline, one month, 3 months and 6 months
Patient discomfort
Patient discomfort was recorded on a visual analog scale, with scores from 0 to 10, where 0 corresponds to no discomfort and 10 corresponds to maximum discomfort.
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Mar 2023
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy Smile Due to Hypermobile Upper LipStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hany Kamel Shalaby, professor, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285343
- Sponsor's protocol ID
- 240/2019 suez canal university
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Randomized Clinical Trial of Containment of the Elevator Muscle of Upper Lip and Wing of Nose Technique Versus Conventional Lip Repositioning for Treatment of Gummy Smile
- ClinicalTrials.gov ID
- NCT07285343
- Acronym / sponsor ID
- 240/2019 suez canal university
- Keywords
- Gummy Smile, Patient Discomfort, Patient Satisfaction, Gingival Display, Smile Line, Smile index, lip repositioning, muscle traction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Dec 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.
The goal of this clinical trial is to compare and evaluate the effectiveness of conventional and modified lip repositioning for the treatment of gummy smile.
The main question it aims to answer:
Which of these treatment modalities (conventional lip repositioning and containment of the elevator muscle of the upper lip and wing of nose (EMULWN)) has the most durable and least relapse in the treatment of gummy smile?"
Researchers will compare:
- The primary outcome was the decrease in excessive gingival display by measuring smile line (gingival display) and smile index before and after treatment modalities.
- The The secondary outcome was to measure the durability and possibility of relapse over 6 months after treatment with high patient satisfaction.
Detailed description
For patients seeking long-term correction of excessive gingival displays, there are different treatment modalities. Both lip repositioning and muscle traction techniques showed improvement in the decrease in the amount of gingival display, while the containment surgery of the muscle of the upper lip and wing of the nose showed durable and satisfactory esthetics with less patient discomfort and less pain immediately after the procedure and needs more time to study or may need some modification. Also, lip repositioning showed satisfactory results to the patients but with more pain immediately after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lip repositioning | Active comparator | Procedure: lip repositioninglip repositioning to treat excessive gingival display |
| Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) | Active comparator | Procedure: Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) techniqueContainment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique in treatment of excessive gingival display |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients aged between 18 and 38 years.
- Gummy smile ranging between 4 and 6 mm, due to short upper lip and hyperactive lip elevator muscles (lip mobility >8 mm).
- Good periodontal health based on the examination of the gingival inflammation index, bleeding index, and probing the depth of gingival pockets.
- Healthy patients or people with well-controlled systemic disease.
Key exclusion criteria (7 listed)
- Smokers.
- Pregnant or lactating women.
- Less than 3 mm of attached gingiva that might create difficulties in flap design, stabilization, and suturing.
- Vertical maxillary excess of more than 6 mm.
- Poorly controlled systemic diseases that preclude local anesthesia.
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 |
|---|---|---|
| lip repositioningLocal anesthesia was administered in the vestibular mucosa. A partial-thickness incision was made at the mucogingival junction from the mesial line angle of the right first molar to the mesial line angle of the left first molar. A second partial- thickness incision, parallel to the first, was made in the labial mucosa, 10 to 12 mm apical to the mucogingival junction. The incisions were connected at each first molar, creating an elliptical outline. The epithelium was removed within the outline of the incisions, leaving the underlying connective tissue exposed. Care was taken to avoid damage to any minor salivary glands in the submucosa. The parallel incision lines were approximated with interrupted stabilization sutures at the midline and other locations along the borders of the incision to ensure proper alignment of the lip midline with the midline of the teeth. Then, a continuous interlocking suture was used to approximate both flap ends. | Procedure or surgery | lip repositioning |
| Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) techniqueLocal anesthesia was administered in the vestibular mucosa and lip then a vertical incision was made on the labial frenum, and two more horizontal incisions were made on the mucogingival line, starting from the frenum incision up to the height of the canines. The flap was carefully divulsed with Goldman Fox scissors and also a curved hemostat, separating the external epithelium from the muscle bundle mucosa on both sides at the height of the lateral incisors and canines. With an absorbable suture thread, the elevator muscle of the upper lip and wing of the nose was pulled downwards, repositioning its bundle nearer the highest portion of the keratinized gingiva. Simple sutures were made, as many as necessary, in order to contain the pulled muscle in this position. The procedure ended up with a continuous suture in the labial frenum and in the horizontal incisions with the use of a 4-0 silk suture thread. The external stitches should be removed in 10-15 days" time. | Procedure or surgery | Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) |
Primary outcome
Measuring smile line (the amount of gingival display in millimeters)
Time frame: at baseline, after one month, after 3 months and after 6 months
The first primary outcome of the study was to measure the change in excessive gingival display by measuring smile line (the amount of gingival display in millimeters) before and after treatment. 1/Smile line (gingival display) Type 1: Very high smile line: 2 mm or more of marginal and attached gingiva visible or more than 2 mm of root or gingiva apical to the cemento-enamel junction visible for the healthy but reduced periodontium. This smile is classified as a "gummy smile." Type 2: High smile line: Between 0 and 2 mm of marginal and attached gingiva visible or between 0 and 2 mm visibility of root and gingiva apical to the cemento-enamel junction visible for the reduced and healthy periodontium. Type 3: Average smile line: Gingival embrasures only visible. Type 4: Low smile line: Gingival embrasure and cemento-enamel junction not visible.
Measuring smile index ratio before and after treatment.
Time frame: at baseline, after one month, after 3 months and after 6 months
The second primary outcome of the study was to measure the change in excessive gingival display by measuring smile index ratio which is (intercommissural width/interlabial gap) to visualize and quantify the frontal smile. The ratio is used for comparing smiles among patients. The lower the smile index, the less youthful the smile appears.
2 secondary outcomes
Patient Satisfaction with Their Smile
Time frame: at baseline, one month, 3 months and 6 months
Patient discomfort
Time frame: immediately after treatment
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 16 Dec 2025.
- 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.
Hany Kamel Shalaby, professor principal investigator
Suez Canal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lip repositioning and Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique in people with Gummy Smile Due to Hypermobile Upper Lip and Excessive Gingival Display, run by Suez Canal University at 2 sites in Egypt.
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 7 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Measuring smile line (the amount of gingival display in millimeters) (time frame: at baseline, after one month, after 3 months and after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2025.