Comparison Between Lip Repositioning and Muscle Traction Technique in Treatment of Gummy Smile

NCT07285343 | Completed DMC

• 1 other identifier: 240/2019 suez canal university
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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 and wing of nose (EMULWN)) has the most durable and least relapse in the treatment of gummy smile?" Researchers will compare:

1. 1.The primary outcome was the decrease in excessive gingival display by measuring smile line (gingival display) and smile index before and after treatment modalities.
2. 2.The The secondary outcome was to measure the durability and possibility of relapse over 6 months after treatment with high patient satisfaction.

Conditions

Gummy Smile Due to Hypermobile Upper Lip; Excessive Gingival Display

Keywords

Gummy Smile; Patient Discomfort; Patient Satisfaction; Gingival Display; Smile Line; Smile index; lip repositioning; muscle traction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at baseline, after one month, after 3 months and after 6 months

Secondary Outcomes (2)

• Patient Satisfaction with Their Smile

  at baseline, one month, 3 months and 6 months

• Patient discomfort

  immediately after treatment

Study Arms (2)

lip repositioning

ACTIVE COMPARATOR

lip repositioning to treat excessive gingival display

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

Procedure: Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique

Interventions

lip repositioning PROCEDURE

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.

lip repositioning

Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique PROCEDURE

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.

Containment of the elevator muscle of the upper lip and wing of nose (EMULWN)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (2)

Periodontology Clinic in Suez Canal University

Cairo, Egypt, 1234, Egypt

Location

Periodontology Clinic in Suez Canal University

Ismailia, Ismailia Governorate, 1234, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Methods

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Hany Kamel Shalaby, professor

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded technique
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 16, 2025
• Study Start: March 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)