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

Cairo University (CU)

Status and phase: Unknown; Early Phase 1

Conditions: Gummy Smile Due to Hypermobile Upper Lip

Treatments: Drug: Botulinum Toxin A Injection; Procedure: Modified Lip Repositioning Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03186547

CEBD-CU-2017-06-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Botulinum Toxin A Injection

Experimental group

Description:

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.

Treatment:

Drug: Botulinum Toxin A Injection

Modified Lip Repositioning Surgery

Experimental group

Description:

this group will receive Modified Lip Repositioning Surgery with follow up at at 2,4,8,12 and 24 weeks.

Treatment:

Procedure: Modified Lip Repositioning Surgery