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

Gummy Smile Due to Hypermobile Upper Lip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03186547
• Other study ID #: CEBD-CU-2017-06-02
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: June 11, 2017
• Last updated: June 19, 2017
• Start date: June 2017
• Est. completion date: June 2018

Study information

• Verified date: June 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Gummy Smile Due to Hypermobile Upper Lip

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction and postoperative side effects	it will be assessed using Questionnaire.	at 4 weeks
Secondary	Improvement of gingival display upon smiling	it will be assessed using Digital ruler on DSS software	at 4,8 and 12 weeks
Secondary	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
Secondary	Lower face esthatics: d)nasolabial angle	it will be assessed using Digital angle measurement on DSS software	at 4,8 and 12 weeks
Secondary	stability of gummy smile correction.	it will be assessed using Digital ruler on DSS software	at the end of 24 weeks.