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

Study Overview
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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.

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.

Official Title
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Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection Versus Modified Lip Repositioning Surgery : A Randomized Clinical Trial

Conditions
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Gummy Smile Due to Hypermobile Upper Lip

Intervention / Treatment
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* Drug: Botulinum Toxin A Injection
* Procedure: Modified Lip Repositioning Surgery


Participation Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin A Injection<br>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. | Drug: Botulinum Toxin A Injection<br>* 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.<br>* Other names: BOTOX;|
| Experimental: Modified Lip Repositioning Surgery<br>this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks. | Procedure: Modified Lip Repositioning Surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction and postoperative side effects | it will be assessed using Questionnaire. | at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of gingival display upon smiling | it will be assessed using Digital ruler on DSS software | at 4,8 and 12 weeks | 
| Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap | it will be assessed using Digital ruler and angle measurement on DSS software | at 4,8 and 12 weeks | 
| Lower face esthatics: d)nasolabial angle | it will be assessed using Digital angle measurement on DSS software | at 4,8 and 12 weeks | 
| stability of gummy smile correction. | it will be assessed using Digital ruler on DSS software | at the end of 24 weeks. |