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临床试验/NCT07159529
NCT07159529已完成不适用

Flapless Versus Flap Technique for Evaluation of Crestal Bone Loss and Osseointegration of Dental Implants

Tanta University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
crestal bone loss and osseointegration

研究概览

简要总结

this study aimed to evaluate both clinically and radiographically the effect of flapless versus flap techniques on initial crestal bone loss and osseointegration of dental implants in lower posterior area. the study is to designed to observe the clinical outcomes such as primary stability and pain within initial hours and days and secondary stability over a 6 month period .

详细描述

this clinical trial was designed to observe the clinical outcomes of techniques of implant installation including flapless and flap techniques about their effect on; osseointegration that measured by checking dental implants stability with resonance frequency analysis device after 6 months of their installation, initial crestal bone loss around the dental implants after 6 months of their installation that that evaluated radiographically and also recording pain perception by the patients within the initial hours and days after implant insertion by both techniques.The patients collected and operated from department of Oral and Maxillofacial surgery, Faculty of Dentistry, Tanta University, Egypt.

Approval of this research was obtained from Faculty of Dentistry, Tanta University Research Ethics Committee (REC). The purpose of the present study was explained to the patients and informed consents were obtained according to the guidelines on human research published by the REC at Faculty of Dentistry, Tanta University.

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 (Participant)

入排标准

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

入选标准

  • •Patients that fulfill one or more of the following criteria were included:
  • •Residual bone height of alveolar ridge more than 8 mm.
  • •Residual bone width of alveolar ridge more than 4 mm.
  • •Healthy and sufficient covering soft tissue (keratinized mucosa).
  • •Distance between inferior border of mandible and the crest of alveolar ridge more than 2cm.
  • •Motivated, cooperative patients with good oral hygiene.

排除标准

  • •Patients with relevant systemic disorder that may compromise bone healing (e.g.: Uncontrolled diabetic).
  • •Extraction socket less than 4 months of healing time.
  • •Patient with Autoimmune disease, or neurologic disorder.
  • •Heavy smokers (more than 15 cigarettes/day).93
  • •Bad oral hygiene.
  • •Patients with history of radiotherapy or chemotherapy.
  • •Patients who are fully edentulous.
  • •Exclusion Criteria:

研究组 & 干预措施

flapless group

Experimental

10 patients received dental implants just by taking a punch of tissue

干预措施: flapless technique (Procedure)

flapless group

Experimental

10 patients received dental implants just by taking a punch of tissue

干预措施: tissue punching (Procedure)

flap group

Experimental

conventional flap elevation to place dental imp;lant

干预措施: flap technique (Procedure)

结局指标

主要结局

crestal bone loss and osseointegration

时间窗: 6 months postoperatively

initial crestal bone loss around the dental implants measured radiographically and secondary stability checked after six months to check osseointegration of the dental implants by resonance frequency analysis device.

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

Abdalla Mohammed Faqe Wais

principal investigator

Tanta University

研究点 (1)

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