Higher Doses of Botulinum Toxin in the Treatment of Gummy Smile

NCT ID: NCT05127018

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-20
• Study Completion Date: 2021-10-20

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.

Detailed Description

The smile is one of the universal facial expressions of humans. Gingival smile is characterized by gingival exposure of >3 mm upon smiling. The degree of gingival exposure can vary substantially between patients, with patients presenting gingival exposure of up to more than 10 mm. The prevalence of gingival smile is 10.57%, and it is more frequently observed in females. Although gingival smile is merely an anatomical variation, it can be considered unattractive, causing significant distress and impacting one's quality of life. Moreover, most orthodontists and dentists regard gingival smile as an important risk factor for dental treatment.

Gingival smile involves a complex interaction between the facial muscles, bone, and skin; specifically, it is related to hypermobility of the upper lip with muscle involvement and alterations in anatomical features, such as a short clinical dental crown, anterior dentoalveolar extrusion, maxillary excess, and a short upper lip. Therapies for gingival smile range from botulinum toxin injections to surgical interventions according to its etiology. Although the outcomes of surgical procedures are long-lasting, botulinum toxin type A treatment is an easy and fast outpatient procedure that requires no downtime and has high efficacy rates. Nevertheless, there are controversies around the optimal dose and injection site of botulinum toxin type A. Moreover, the efficiency of botulinum toxin type A for gingival smile varies markedly between studies, with the improvement rate of gingival exposure ranging from 62.06% to 98%. Sucupira and Abramovitz advocate the use of a low amount of botulinum toxin type A of 1.95 U per side for the treatment of gingival smile. They noted an average satisfaction level of 9.75 on a 10-point scale with this approach. They claimed that higher doses does not provide further benefit, and, in fact, could lead to lip ptosis, asymmetry, and excessive upper lip length. However, Polo disagreed with their argument, claiming 2-5 U injection of botulinum toxin type A according to the severity of gingival smile. In this regard, Garcia and Fulton showed that low-dose injection of botulinum toxin per muscle (2-5 IU) was as effective as higher doses. Though prior studies have demonstrated a correlation between higher doses of botulinum toxin and intensity and duration of muscle paralyses, no conclusion can be drawn regarding duration and intensity of doses used in the recent studies. A safe approach advocated by some authors consists of starting with low toxin doses initially, with retouching at a later stage if required. In this study, the investigators compared botulinum toxin type A efficiency using the average-dose method (2-5 U botulinum toxin type A per side determined according to the severity of anterior gingival smile) and , the higher-dose method (3-10 U botulinum toxin type A per side determined according to the severity of anterior gingival smile). The investigators aimed to assess the efficiency and duration of these approaches, as well as side effects and patients' satisfaction with treatment.

Conditions

Smiling; Botulinum Toxins, Type A

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the average-dose method

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.

Group Type: ACTIVE_COMPARATOR

injection of Botulinum type A

Intervention Type: 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.

the higher-dose method

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.

Group Type: EXPERIMENTAL

injection of Botulinum type A

Intervention Type: 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.

Interventions

injection of Botulinum type A

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.

Intervention Type: DRUG

Other Intervention Names

injection of Botulinum type A(Botox, Allergan, Irvine, CA)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Gong Xi, DDS

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xi Gong

Role: PRINCIPAL_INVESTIGATOR

Peking University School of Stomatology

Locations

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

pkusshighdose

Identifier Type: -

Identifier Source: org_study_id