Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A

NCT04820543 | Completed Phase 4

• 1 other identifier: pkussGS2
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, its dosage and injection sites effect among patients are controversial.The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage and injection sites. In this prospective self-controlled study, healthy GS participates who had an anterior gingival exposure (GE) of more than 3 mm were enrolled and administered single-point injection of 2 U BTX-A per side in the Simplified Method. And after 8 months, the Individualized Method was administered with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment. Data were collected at baseline and 4, 12, and 32 weeks of follow-up.

Conditions

Smiling; Botulinum Toxins, Type A

Keywords

gummy smile; botulinum toxin; dose and injection site

Outcome Measures

Primary Outcomes (1)

• anterior gingival exposure (GE)

  The distance from the superior margin point of the right incisor to the lower margin of the upper lip upon maximum smile.

  4 weeks postinjection

Secondary Outcomes (1)

• bilateral posterior GE

  4 weeks postinjection

Study Arms (2)

Simplified Method

EXPERIMENTAL

In this method, a uniform BTX-A injection technique with single-site injection of 2 U BTX-A (total, 4 U) at both right and left levator labii superioris alaeque nasi muscles (LLSAN) was administered. The injection points located at the muscle bulge at the uppermost part of the nasolabial fold.

Drug: injection of Botulinum type A

Individualized Method

EXPERIMENTAL

In this method, the patients were administered BTX-A after 8 months when the effect of the previous injection vanished. And A dosage and injection sites were individualized according to the degree of severity of anterior GE presented pretreatment. For mild GS (3 to\< 5mm), 2 U BTX-A was injected at bilateral LLSAN. For moderate (5 to \< 7mm) and severe GS (≥ 7mm), 3 U and 5 U of BTX-A were injected per side (total, 6 U and 10U). And The injection points located at both LLSAN and the Yonsei point, with half doses at each point.

Drug: injection of Botulinum type A

Interventions

injection of Botulinum type A DRUG

The participates were allocated to two different application methods: Simplified Method for the first injection and Individualized Method 8 months later. All the patients underwent twice injection with each methods with no change of the BTX-A(Botox, Allergan, Irvine, CA) and other injection details: Lyophilized 100 U of Botox was reconstituted in 2.5 mL of 0.9% sodium chloride solution. The injections were made with a 27-gauge insulin syringe. The treatment was an outpatient procedure and all injections were performed by one of the authors (X.G.). No anesthesia was given during the procedure.

Also known as: injection of Botulinum type A(Botox, Allergan, Irvine, CA)

Individualized Method; Simplified Method

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 3.0-mm anterior gingival exposure upon unrestricted, "full-blown" smiling
• healthy adults

You may not qualify if:

• contraindication of BTX-A
• previous diseases or treatments affecting the position of the gingiva or upper lips
• history of BTX-A injections to the head or neck region
• facial paralysis
• having received and/or receiving active orthodontic treatment that includes vertical dimension treatment, such as extrusion and intrusion, and presence of periodontal disease
• subject's refusal to participate

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, 100010, China

Location

MeSH Terms

Conditions

Smiling

Condition Hierarchy (Ancestors)

Facial Expression; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and the outcomes assessor will be prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 29, 2021
• Study Start: February 20, 2019
• Primary Completion: November 20, 2019
• Study Completion: June 20, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)