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临床试验/NCT03754894
NCT03754894已完成不适用

Effect of Using a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue Randomized Clinical Study

Ain Shams University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
increasing attached gingiva width around implant

研究概览

简要总结

Keratinized gingiva around dental implants are necessary to achieve esthetic appearance in the anterior teeth, also it is more resistant to abrasion, recession, less in plaque accumulation and inflammation, and easy to manipulate during stage two surgery and impression making in prosthetic stage. For the aforementioned reasons over year's authors have developed many techniques to increase the amount of keratinized gingiva around the dental implants such techniques are apically and laterally repositioned flaps , free gingival grafts, acellular dermal matrix allograft , coronally repositioned flap and sub epithelial connective tissue flaps . Huh et al compared the effects of the use of a ready-made plastic stent on the width of peri-implant keratinized mucosa with those of conventional methods. In addition, the effect of a plastic stent on peri-implant soft tissue was examined through histological observations. Reported that the width of the keratinized mucosa was significantly higher and the distance from the top of the implant platform to the mucogingival junction was significantly longer in the ready-made plastic stent group.

Thus this study will be performed to compare between the effect of the use of a ready- made plastic stent on the width of peri-implant keratinized tissue and that of conventional methods during first stage of implant surgery.

详细描述

This prospective clinical study will be conducted on Twenty patients will be selected from the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department, Faculty of Dentistry, Ain Shams University This methodology will be reviewed by Ain shams university, faculty of dentistry research ethics committee

Inclusion criteria:

  1. Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
  2. Both genders.
  3. Age from 20 -50 years old.
  4. Having at least one missing tooth at Posterior area (premolars or molars).
  5. Attached gingiva width below 3 mm.
  6. Patient should agree to sign a written consent after the nature of the study will be explained.

Exclusion criteria:

  1. Smokers ( >10 cigs/day ) .
  2. Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
  3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  4. Prisoners and handicapped patients.
  5. Patients with periodontal or periapical infections.

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)

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
  • 2- Both genders. 3- Age from 20 -50 years old. 4- Having at least one missing tooth at Posterior area (premolars or molars). 5- Attached gingiva width below 3 mm. 6- Patient should agree to sign a written consent after the nature of the study will be explained.

排除标准

  • Smokers ( >10 cigs/day ) .(Ata-Ali et al , 2015)
  • Vulnerable groups (as pregnant females and decisional impaired individuals) will be excluded from the study.
  • Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  • Prisoners and handicapped patients.
  • Patients with periodontal or periapical infections.

结局指标

主要结局

increasing attached gingiva width around implant

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

ahmed hamdy mahmoud

teaching assistant of oral medicine and periodontology

Ain Shams University

研究点 (2)

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