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临床试验/NCT06473805
NCT06473805尚未招募3 期

3D Printed Polymethylmethacrylate Versus Polyether Ether Ketone Implant for Management of Gummy Smile Through VISTA Technique: A Randomized Clinical Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
To measure amount of gingival display in different follow-up intervals

研究概览

简要总结

the most important esthetic concern for dental patients is excessive display of gingiva during smiling due to multiple causes e.g. hyperplasia of gingival, skeletal overgrowth of the anterior maxilla, altered passive eruption, maxillary alveolar tooth extrusion, short lip and lip hypermobility therefore accurate diagnosis of these factors is essential before treatment to ensure the most suitable approach is chosen. Maxillary overgrowth may cause sub nasal skeletal depression that lead to retraction of upper lip during smiling, causing gingiva display. The aim of this study is to describe an alternative technique to treat gingival smile with minimally invasive vestibular incision subperiosteal tunnel access (VISTA) to place 3D printed polymethylmethacrylate (PMMA)-based bone cement versus polyether ether ketone (PEEK) for lip repositioning.

详细描述

A smile plays an important role in determining a person's initial impression and its assessment has become integral to clinical evaluation owing to how appealing a smile could be among people. A gingival smile, gummy smile or high smile line is an aesthetic concern with 10-12% prevalence among dental patients mainly in women and is diagnosed when a patient shows ≥3 mm of free gingiva.

A gummy smile may result from a single cause but is more commonly found to be the result of an interplay of multiple factors and identifying the causative factor is the basis for its treatment. It may be broadly caused by dentoalveolar discrepancies or non-dentoalveolar discrepancies. Dentoalveolar discrepancies include short clinical crowns, altered passive eruption and gingival hypertrophy/hyperplasia. These discrepancies can be improved by restorative and periodontal approaches. Non-dentoalveolar discrepancies include hyperactive upper lip, short, or incompetent upper lip and vertical maxillary excess. Orthognathic surgery, lip repositioning (LRT), orthodontic treatment, and Botox injections are the main treatment modalities typically employed for treating thesis conditions.

LRT, first described by Kostianovsky and Rubinstein in 1976, has shown excellent efficacy in treating gummy smile, showing an average reduction of 2.71 to 3.4 mm at 6 months of follow-up in previous systematic reviews. However, the traditional technique has reported different partial or complete degrees of relapse. Therefore, different modifications have been developed to improve the predictability and stability of the technique and reduce morbidity and complications.

Most modifications reported in the last 5 years aim to provide improved stability of outcome by introducing techniques that eliminate or restrict the function of the muscles responsible for raising the upper lip during smile or that alter/restrict the hypermobility of lip movement. Some of these techniques include the use of adjuvants such as botulinum toxin (BOTOX).

Injecting overactive muscles with measured amount of botulinum toxin results in a reduction of muscle activity, relaxation of the lip muscles and decreasing upward pull on the lip. The improvement achieved is almost immediate but remains only for a period of 3-6 months, before slowly fading. This relatively short duration is the major disadvantage of the technique, that require constant reapplication and the effects of long-term use of Botox have not been adequately researched

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Patients will be randomly allocated according to predetermined computer-generated randomization using www.Randomizer.org

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having excessive gingival display ≥ 4 mm.
  • Clinically diagnosed and radiographically confirmed maxillary subnasal depression.
  • Good compliance with the plaque control instructions following therapy.
  • Availability for follow-up and maintenance program.

排除标准

  • Pregnant and lactating females.
  • Patients with insufficient keratinized gingiva.
  • Patients who had done any surgical procedure in the same region.
  • Patients who had done fixed or removable prostheses in any anterior maxillary teeth.
  • patients currently using medications linked to gingival hyperplasia.
  • Systemic diseases that could affect the outcome of the therapy (according to the modified Burkett's health history questionnaire).
  • Vulnerable groups of patients' e.g. (handicapped patients).

结局指标

主要结局

To measure amount of gingival display in different follow-up intervals

时间窗: at 1, 3, 6 and 12 months postoperatively

To measure amount of gingival display in millimeters in different follow-up intervals.

次要结局

  • To evaluate patient satisfaction(at 1, 3, 6 and 12 months postoperatively)
  • to evaluate postoperative pain(at 1, 3, 6 and 12 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Zidan

Associate Lecturer in oral medicine and periodontology department

Ain Shams University

研究点 (1)

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