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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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03186547
Enrollment
22
Registered
2017-06-14
Start date
2017-06-30
Completion date
2018-06-30
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gummy Smile Due to Hypermobile Upper Lip

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.

Interventions

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.

PROCEDUREModified 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

single blind

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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 .

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction and postoperative side effectsat 4 weeksit will be assessed using Questionnaire.

Secondary

MeasureTime frameDescription
Improvement of gingival display upon smilingat 4,8 and 12 weeksit will be assessed using Digital ruler on DSS software
Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gapat 4,8 and 12 weeksit will be assessed using Digital ruler and angle measurement on DSS software
Lower face esthatics: d)nasolabial angleat 4,8 and 12 weeksit will be assessed using Digital 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026