Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile

NCT05127018 | Completed Phase 1 Results FDA Drug

• 1 other identifier: pkusshighdose
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Botulinum type A (BTX-A) is an easy and efficacious treatment for gingival smile (GS). However, the necessary for higher-doses among patients are controversial. The objective was to compare the reduction of gingival exposure using two methods in patients with different dosage. 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 with 2-5 U BTX-A (total, 4-10 U) injections into 1-2 points according to the severity presented pretreatment in the Average-dose Method. And after 8 months, the Higher-doses Method was administered the same point injection of 3-10 U BTX-A (total, 6-20 U). Data were collected at baseline and 4, 12, 32 and 60 weeks of follow-up.

Conditions

Smiling; Botulinum Toxins, Type A

Keywords

gummy smile; botulinum toxin; dose

Outcome Measures

Primary Outcomes (1)

• Anterior Gingival Exposure (GE) 4 Weeks Post-injection

  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 (3)

• Anterior Gingival Exposure (GE) 12 Weeks Post-injection

  12 weeks postinjection

• Anterior Gingival Exposure (GE) 24 Weeks Post-injection

  24 weeks postinjection

• Anterior Gingival Exposure (GE) 48 Weeks Post-injection

  48 weeks postinjection

Study Arms (2)

the average-dose method

ACTIVE COMPARATOR

With the average-dose method, the dose was individualized according to the severity of anterior gingival exposure pretreatment. For mild gingival smile (3-5 mm), a single-site injection of 2 U botulinum toxin type A \[total, 4 U\] at both the right and left levator labii superioris alaeque nasi muscles) was administered. For moderate (5-7 mm) and severe (≥7 mm) gingival smile, 3 U and 5 U of botulinum toxin type A, respectively, were injected per side (total, 6 U and 10U, respectively). The injection points were located at bilateral levator labii superioris alaeque nasi muscles and at the Yonsei point26, with half doses administered at each point.

Drug: injection of Botulinum type A

the higher-dose method

EXPERIMENTAL

With this method, patients were administered botulinum toxin type A after 8 months when the effect of the previous injection had vanished. The injection dose (U) per side was set as the absolute value of the preoperative anterior gingival exposure (mm). For example, if the preoperative anterior gingival exposure was 5mm, then the patient would be injected with 5 U of botulinum toxin per side (total, 10U). The injection points were located at bilateral levator labii superioris alaeque nasi muscles and at the Yonsei point26, with half doses administered 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)

the average-dose method; the higher-dose 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

Results Point of Contact

• Title: Xi Gong
• Organization: Peking University School of Stomatology

gongx31480528@163.com

15201304426

Study Officials

• Xi Gong

  Peking University School of Stomatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: November 20, 2019
• Primary Completion: August 20, 2020
• Study Completion: October 20, 2021
• Last Updated: April 26, 2023
• Results First Posted: April 26, 2023

Record last verified: 2023-04

Locations

CN (1)