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临床试验/NCT07068750
NCT07068750已完成不适用

Evaluation of Implant Site Preparation With Three Different Drilling Systems in Posterior Maxilla (Randomized Controlled Clinical Trial)

ALZAHRANI,MOHAMMED AHMED Y1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月16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
发起方
入组人数
30
试验地点
1
主要终点
primary and secondary implant stability

研究概览

简要总结

The rationale for conducting this study is to compare between three implant drilling systems (conventional sequential system, single drilling system and osseodensification surgical drills) for implant site preparation in the posterior maxillay region through measuring implant stability and bone density around dental implants. Therefore, the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ), whereas the secondary objective is to assess marginal bone loss, the operation time for the osteotomy preparation, and finally bone density through measuring grey values on CBCT around implants for all drilling methods at different evaluation intervals of the study.

详细描述

Primary stability is a critical factor that determines the long-term success of dental implants. It is responsible for preventing the micro- motion of the implant in the bone site, promoting natural healing and effective bone formation until adequate biological stability has been established. Primary stability of dental implants is highly dependent on implant design, surgical technique and the bone density and quality. Conventional implant shaping drills are widely used because they are easy to handle, time-efficient, and not expensive. Nevertheless, the heat that they generate might cause tissue damage, necrosis to the surrounding structures, difficulty in providing a proper three-dimensional positioning and the risk of invading and injuring important anatomical structures such as the inferior alveolar nerve and the Schneiderian membrane. Hence, several studies introduce different techniques and methods to resolve these problems. Recently, new hollow drill in a single drilling system was developed. It was hypothesized that hollow drill design with single drilling system results in decreasing the time for surgery (faster implant placement) and minimum bone removal for implant site preparation. Moreover, it was found that it reduces bone trauma, micro-fractures and allow fasters healing time. Moreover, the hollow design of the single drilling system allows harvesting of the bone core, that bone which result during the osteotomy site preparation can be used in bone grafting as autogenous bone grafting material. Osseodensification (OD) is also a new method of biomechanical bone preparation performed for dental implant placement. The procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur that is fluted such that it densifies the bone with minimal heat elevation. OD, a bone nonextraction technique, was developed by Huwais 2013 and done using specially designed burs (Densah™ burs) that help densify bone as they prepare an osteotomy these burs provide advantages of both osteotomes combining the speed along with improved tactile control of the drills during osteotomy.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Patient between 20-50 years old.
  • •remaining bone height of more than 8 mm, remaining bone width of 6 mm
  • •Adequate keratinized soft tissue.
  • •Favorable pattern of occlusion.
  • •Good oral hygiene.
  • •Patient ability to comply with the required recall visits

排除标准

  • •Insufficient bone width (less than 6 mm) mesiodistal or buccolingually.
  • •Patients having any uncontrolled systemic disease which could affect bone healing.
  • •Patients treated with radiotherapy to the head and neck area within the past 12 months.
  • •Heavy Smokers (more than 20 cigarette per day) according to WHO.
  • •Inability or unwillingness to return for follow-up visits.

研究组 & 干预措施

Group II: 10 patients received dental implants using Densah burs in posterior maxilla

Active Comparator

干预措施: patients received dental implants using Densah burs in posterior maxilla (Procedure)

Group III: 10 patients received dental implants using conventional drills in posterior maxilla

Active Comparator

干预措施: patients received dental implants using conventional drills in posterior maxilla (Procedure)

Group I: 10 patients received dental implants using single drilling system in posterior maxilla

Active Comparator

干预措施: patients received dental implants using single drilling system in posterior maxilla (Procedure)

结局指标

主要结局

primary and secondary implant stability

时间窗: the primary stability will be taken immediately after implant placement. while secondary implant stability will be taken after 6-months

the primary objective of this study is to evaluate the primary and secondary implant stability performed by the three types through measuring implant stability quotient (ISQ)

次要结局

  • assessment of marginal bone loss(marginal bone loss will be measured after 6 months from implant placement)
  • operation time(operation time will be measured immediately during implant placement in minutes.)

研究者

发起方
ALZAHRANI,MOHAMMED AHMED Y
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ALZAHRANI,MOHAMMED AHMED Y

B.D.S (2017) Faculty of Dentistry, Mansoura University

Mansoura University

研究点 (1)

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