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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gummy Smile Due to Hypermobile Upper Lip
• Intervention / Treatment: Drug: Botulinum Toxin A Injection; Procedure: Modified Lip Repositioning Surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: 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.; Other Names: BOTOX
EXPERIMENTAL: Modified Lip Repositioning Surgery; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): June 1, 2018

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: CEBD-CU-2017-06-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes