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

Early Phase 1

• Conditions: Gummy Smile Due to Hypermobile Upper Lip
• Interventions: Drug: Botulinum Toxin A Injection; Procedure: Modified Lip Repositioning Surgery

• Registration Number: NCT03186547
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2017-06
• Study Start: 2017-06
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Read More

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 .

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin A Injection	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.
Modified Lip Repositioning Surgery	Modified Lip Repositioning Surgery	this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction and postoperative side effects	at 4 weeks	it will be assessed using Questionnaire.

Secondary Outcome Measures

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