Effects of Dose and Injection Site for Gummy Smile Treatment With Botulinum Type A: A Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- anterior gingival exposure (GE)
研究概览
简要总结
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.
详细描述
The smile is one of universal facial expressions of the humans. Gingival smile (GS) or gummy smile defined as any exposure of the gingiva >2 or 3 mm upon smiling, and can substantially vary from patient to patient, with patients presenting gummy exposures of up to more than 10 mm. The prevalence of GS is 10.57%, and it is more frequently seen in women. Although only an anatomical variation, it can be considered unattractive and cause significant distress and impact on one's quality of life. Moreover, most orthodontists and dentists regard GS as an important risk factors for dental treatment.
GS involves a complex interaction of facial muscles, bones and skin, specifically, it is related to the hypermobile upper lip (HUL) by the involved muscles and alterations in anatomical features such as short clinical dental crown, anterior dentoalveolar extrusion, maxillary excess and short upper lip. Therapies for GS range from botulinum toxin injections to surgical interventions according to its etiology. Whereas the outcomes of surgical procedures are long-lasting, botulinum toxin type A (BTX-A) treatment is an easy and fast outpatient procedure, requiring no downtime and with high efficacy rates. Nevertheless, there are controversies on the dosage and injection sites of BTX-A, and the efficiency of BTX-A for GS treatment shows great variation in different studies, with the improvement rate of gingival exposure (GE) ranging from 62.06% to 98%, Sucupira and Abramovitz advocate the use of an average amount of BTX-A of 2 U at bilateral levator labii superioris alaeque nasi muscles(LLSAN) for the treatment of GS, and an average satisfaction level of 9.75 on a 10-point scale was noted in their study. In their article, use of larger dosages and additional injection sites is discouraged: "Other target muscles described in the literature do not give any additional benefit to this application and could easily lead to lip ptosis, inferior lip protrusion, asymmetry, or excessive lengthening of the upper lip." Polo disagreed their argument. They believe that dosage and injection sites of BTX-A need to be individualized according to the degree of severity presented. However, no clinical study compared and verified their divergence, and the highly personal experience and uncertainty still limit the use of BTX-A for GS treatment. Some authors are of the opinion that injection with BTX-A is a safe and cosmetically effective treatment for GS only when performed by experienced practitioners. Other studies preferred to initiate the treatment with average-dose BTX-A injection to single sites initially, with retouching at a later stage, as and when required. Based on the lack of studies at the stage of creating the hypothesis for this study, the investigators compared the efficiency using the simplified method use of 2U BTX-A of at bilateral LLSAN and the individualized injection of dosage and injection sites according to the severity of anterior GS presented in patients, and also to assess safety and patients' satisfaction with the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant and the outcomes assessor will be prevented from having knowledge of the interventions assigned to individual participants.
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 3.0-mm anterior gingival exposure upon unrestricted, "full-blown" smiling
- •healthy adults
排除标准
- •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
研究组 & 干预措施
Simplified Method
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.
干预措施: injection of Botulinum type A (Drug)
Individualized Method
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.
干预措施: injection of Botulinum type A (Drug)
结局指标
主要结局
anterior gingival exposure (GE)
时间窗: 4 weeks postinjection
The distance from the superior margin point of the right incisor to the lower margin of the upper lip upon maximum smile.
次要结局
- bilateral posterior GE(4 weeks postinjection)
研究者
Gong Xi
principal investigator
Peking University
