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

NCT ID: NCT07285343

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-03-01

Brief Summary

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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. 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. The The secondary outcome was to measure the durability and possibility of relapse over 6 months after treatment with high patient satisfaction.

Detailed Description

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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.

Conditions

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Gummy Smile Due to Hypermobile Upper Lip Excessive Gingival Display

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Single-blinded technique

Study Groups

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lip repositioning

lip repositioning to treat excessive gingival display

Group Type ACTIVE_COMPARATOR

lip repositioning

Intervention Type 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.

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

Containment of the elevator muscle of the upper lip and wing of nose (EMULWN) technique in treatment of excessive gingival display

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Interventions

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lip repositioning

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.

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients aged between 18 and 38 years.
2. Gummy smile ranging between 4 and 6 mm, due to short upper lip and hyperactive lip elevator muscles (lip mobility \>8 mm).
3. Good periodontal health based on the examination of the gingival inflammation index, bleeding index, and probing the depth of gingival pockets.
4. Healthy patients or people with well-controlled systemic disease.

Exclusion Criteria

1. Smokers.
2. Pregnant or lactating women.
3. Less than 3 mm of attached gingiva that might create difficulties in flap design, stabilization, and suturing.
4. Vertical maxillary excess of more than 6 mm.
5. Poorly controlled systemic diseases that preclude local anesthesia.
6. Altered passive eruption, which needs gingivectomy or an apically positioned flap.
7. Skeletal causes of gummy smile as protruded maxilla.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hany Kamel Shalaby, professor

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

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Periodontology Clinic in Suez Canal University

Cairo, Egypt, Egypt

Site Status

Periodontology Clinic in Suez Canal University

Ismailia, Ismailia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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240/2019 suez canal university

Identifier Type: -

Identifier Source: org_study_id