Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection

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

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2018-06-30

Brief Summary

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The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.

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Detailed Description

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In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.

Conditions

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Gummy Smile Due to Hypermobile Upper Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

single blind

Study Groups

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Botulinum Toxin A Injection

this group will receive Botulinum Toxin A Injection at doses of 2.5 or 5 IU (depending on the degree of gum exposure) on each side of the nasolabial fold with follow up at at 2,4,8,12 and 24 weeks.

Group Type EXPERIMENTAL

Botulinum Toxin A Injection

Intervention Type DRUG

adult patients with gummy smile due to hypermobile upper lip will receive Botulinum Toxin A Injection with a single injection1 cm lateral to the ala horizontally and 3 cm above the lip line vertically.

Modified Lip Repositioning Surgery

this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks.

Group Type EXPERIMENTAL

Modified Lip Repositioning Surgery

Intervention Type PROCEDURE

the surgical procedure will be done by removal of strip of epithelium by careful dissection and stabilizing the new mucosal margin to the gingiva to improve the gingival display in adult patients with gummy smile.

Interventions

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Botulinum Toxin A Injection

adult patients with gummy smile due to hypermobile upper lip will receive Botulinum Toxin A Injection with a single injection1 cm lateral to the ala horizontally and 3 cm above the lip line vertically.

Intervention Type DRUG

Modified Lip Repositioning Surgery

the surgical procedure will be done by removal of strip of epithelium by careful dissection and stabilizing the new mucosal margin to the gingiva to improve the gingival display in adult patients with gummy smile.

Intervention Type PROCEDURE

Other Intervention Names

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BOTOX

Eligibility Criteria

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Inclusion Criteria

* Adults with age range from 18 - 30 years.
* Excessive gingival display more than 3 mm during smiling.
* Patients having hypermobile upper lip with or without (mild / moderate) vertical maxillary excess.
* Patients with normal morphology of clinical crowns.
* Normal lip separation (ILG) at rest
* Medically free subjects.

Exclusion Criteria

* Patients with systemic diseases or neuromuscular disorders.
* Gummy smile with gingival display more than 8 mm during smiling.
* Severly long face (VME) patients.
* Patients with periodontal disease or gingival hyperplasia .
* Medically compromised patients contraindicated for surgery .
* Pregnant or lactating female patients.
* Patients with inadequate attached gingiva .

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes