Application of Botulinum Toxin at the Yonsei Point for the Treatment of Gummy Smile

NCT04527744 | Completed

• 1 other identifier: pkussyonseipoint
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present study will be to evaluate the efficacy of a single dose of botulinum toxin (BTX) at the Yonsei point for the treatment of gummy smile (GS). In this double-blind single-site randomized clinical trial, A total number of 36 patients with gummy smile will be enrolled in the study at Peking University School and Hospital of Stomatology over a period of 12 months. Patients will be included and randomized 1:1 to two groups for BTX-A treatment at different injection point. For experimental group, Three units of onabotulinumtoxinA (BTX-A) per site (90 hemifaces) will be initially injected at the Yonsei point. For control group，the same dose of BTX will be injected into the levator labii superioris alaeque nasi muscle, and the injection point is located 3 to 5 mm lateral to each nostril, which was a classical injection point of this treatment. The patients will be then assessed at 2, 4, 12, 36 and 72 weeks postinjection. All subjects underwent standardized measurements by a single examiner, including dynamic and static measurements and a lateral cephalometric radiograph. In addition, facial photos and videos and a questionnaire of self-assessment will be obtained. The primary outcome measurement is the anterior gingival exposure measurements when the subject get an achieve full, unrestricted, spontaneous smiles 2 weeks postinjection.

Conditions

Smiling; Botulinum Toxins, Type A

Keywords

gummy smile; botulinum toxin; Yonsei point

Outcome Measures

Primary Outcomes (1)

• the dynamic measurements anterior gingival exposure (mm)

  anterior gingival exposure, defined as the distance between the superior margin point of the right incisor and the lower margin of the upper lip, measured when the subject get an achieve full, unrestricted, spontaneous smiles using the vernier caliper

  2 weeks postinjection

Secondary Outcomes (1)

• the dynamic measurements bilateral posterior gingival exposure (mm)

  2 weeks postinjection

Other Outcomes (10)

• the dynamic measurements bilateral horizontal position of commissures (mm)

  2 weeks postinjection

• the dynamic measurements bilateral vertical position of commissures (mm)

  2 weeks postinjection

• the static measurements of the exposed medial incisor (mm)

  2 weeks postinjection

Study Arms (2)

the Yonsei point group

EXPERIMENTAL

Three units of onabotulinumtoxinA (BTX-A) per site (90 hemifaces) will be initially injected at the Yonsei point.

Procedure: the injection of onabotulinumtoxinA at different point

the levator labii superioris alaeque nasi muscle group

ACTIVE COMPARATOR

For control group，the same dose of BTX will be injected into the levator labii superioris alaeque nasi muscle, and the injection point is located 3 to 5 mm lateral to each nostril, which was a classical injection point of this treatment.

Procedure: the injection of onabotulinumtoxinA at different point

Interventions

the injection of onabotulinumtoxinA at different point PROCEDURE

For experimental group, Three units of onabotulinumtoxinA (BTX-A) per site (90 hemifaces) will be initially injected at the Yonsei point. For control group，the same dose of BTX will be injected into the levator labii superioris alaeque nasi muscle, and the injection point is located 3 to 5 mm lateral to each nostril, which was a classical injection point of this treatment.

the Yonsei point group; the levator labii superioris alaeque nasi muscle group

Eligibility Criteria

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

You may qualify if:

• Gingival exposure ≥3.0mm upon unrestricted "full-blown" smiling
• Age: 18-60 years

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
• 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 Officials

• Zhihui Tang, MD

  Peking University School of Stomatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: 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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: In this double-blind single-site randomized clinical trial, A total number of 36 patients with gummy smile will be enrolled in the study at Peking University School and Hospital of Stomatology over a period of 12 months. Patients will be included and randomized 1:1 to two groups for BTX-A treatment at different injection point.

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 26, 2020
• Study Start: October 17, 2020
• Primary Completion: November 17, 2020
• Study Completion: October 17, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)