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临床试验/NCT05057286
NCT05057286已完成4 期

The Effect of a Combination Between Clinical Crown Lengthening Surgery and Botulinum Toxin A Injection in Gummy Smile Treatment

University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Clinical crown length

研究概览

简要总结

Background: The demand for beauty is increasing in society as everyone is looking for cosmetic improvement, including gummy smile correction.

Object: This study aims to evaluate the efficacy of a combination of a clinical tooth crowns lengthening surgery following by a BTX-A injection in gummy smile treatment upon based on clinical assessment and photography

Method: An uncontrolled longitudinal study was implemented at the Faculty of Odonto-Stomatology (FOS) of the University of Medicine and Pharmacy at Ho Chi Minh City (UMPH), Viet Nam, from August 2020 to May 2021. Twenty patients (19 females and one male) at a mean age of 24 years old who came for gummy smile chief complaint were included in the study. Subjects were operated to lengthen the clinical crown following an additional botulinum toxin A injection two months post-surgery. All the participants answered the smile esthetic satisfactory questions and were photographed at the time before treatment (T0), two months after clinical crown lengthening surgery (T1), two weeks (T2), and two months (T3) follow-up visits after BTX-A injection. The gingival exposure (GE) and clinical crown length (CCL) were measured at each time point for analysis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gummy smile because of 2 combined etiologies:
  • Short clinical crown of teeth due to the altered passive tooth eruption
  • Hyperactivity of upper lip muscles (lip mobility level > 8mm)

排除标准

  • Pregnant or breastfeeding patients
  • Gummy smiles due to:
  • Maxillary bone overgrowth (maxillary hypertrophy)
  • Vertical maxillary excess
  • Neuromuscular disorder
  • Gingival hyperplasia due to medicine, supplements, or neuromuscular transmission inhibiting agents
  • Systematic diseases that can affect the result of surgical treatment (such as diabetes, heart disease taking blood anticoagulant medicament, blood diseases, immunodeficiency disease etc.)
  • Allergy to BTX-A or albumin
  • History of taking BTX-A injection in the head-neck area formerly
  • Patient with any contraindication of surgery

结局指标

主要结局

Clinical crown length

时间窗: Two months after Botulinum toxin A injection (T2)

The clinical crown length is measured in millimeters using digital caliper and periodontal probe

Gingival exposure

时间窗: Two months after Botulinum toxin A injection (T2)

The outcome is measured in millimeters based on photos of subjects included

次要结局

未报告次要终点

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nguyen Thu Thuy

Deputy Head of Department of Periodontology

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

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