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

NCT03186547 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: CEBD-CU-2017-06-02
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gummy Smile Due to Hypermobile Upper Lip

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction and postoperative side effects

  it will be assessed using Questionnaire.

  at 4 weeks

Secondary Outcomes (4)

• Improvement of gingival display upon smiling

  at 4,8 and 12 weeks

• Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap

  at 4,8 and 12 weeks

• Lower face esthatics: d)nasolabial angle

  at 4,8 and 12 weeks

• stability of gummy smile correction.

  at the end of 24 weeks.

Study Arms (2)

Botulinum Toxin A Injection

EXPERIMENTAL

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

Modified Lip Repositioning Surgery

EXPERIMENTAL

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

Interventions

Botulinum Toxin A Injection 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.

Also known as: BOTOX

Botulinum Toxin A Injection

Modified Lip Repositioning Surgery 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.

Modified Lip Repositioning Surgery

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 14, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share