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临床试验/NCT07001813
NCT07001813已完成不适用

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年8月1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
16
试验地点
1
主要终点
clinical assessment of primary stability of dental implant

研究概览

简要总结

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study

详细描述

Dental implants have become a common choice among the treatment options for missing teeth rehabilitation and has remarkably high survival and success rates Since the introduction of implants into clinical practice more than several decades ago. The success rate of dental implants, over the last ten years, has been about 90- 95%.

Invasive and non-invasive clinical tests are available like histomorphometric analysis, radiographic analysis, push- and pull-out tests, percussion tests, Periotest and resonance frequency analysis (RFA) are employed to assess the steadiness of dental implants to assess objectively implant stability at different stages of its service life to verify successful implantation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Male patients aged between 21 and 40 years.
  • •General good health.
  • •Absence of any relevant systemic disease.
  • •Presence of a hopeless maxillary posterior tooth that requires extraction.
  • •Extraction site suitable for replacement by a dental implant.
  • •Cases have adequate bone width and length.
  • •Volunteer subjects must sign an informed consent.

排除标准

  • •Poor oral hygiene with no possibility of improvement.
  • •Smokers (more than 10 cigarettes per day).
  • •Chronic treatment with any medication known to affect oral status and bone turnover.
  • •Drug or alcohol abuse.

研究组 & 干预措施

socket preserved

Active Comparator

(8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

干预措施: socket preserved (Device)

non preserved sockets

Placebo Comparator

(8 cases): was not exposed to any type of socket preservation after the extraction procedure.

干预措施: non preserved socket (Device)

结局指标

主要结局

clinical assessment of primary stability of dental implant

时间窗: immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis

implant stability assessment by 1. rachet insertion torque * The implant was installed into the osteotomy site using the motorized method with the engine set at 50 rpm and 35-50 N/cm torque. * A ratchet was used to place the implant to the desired depth when the insertion torque was more than 35N/cm torque. 2. osstell device (ISQ) Make it possible to monitor osseointegration in a precise and objective manner. * Osstell helps to objectively and non-invasively determine implant stability. The prob attached to the instrument via a cable and measurements are displayed on the black lit display. * The device held in a right angle to the center toward the implant to be examined, the maximum deviation angle from the orthoradial direction of percussion is 45 degrees. In addition, the rod and the test surface must maintain 0.6-2.5 mm distance according to the operating instructions. * The implant stability using OSTELL device was taken immediately postoperative and was assessed after 4 months

radiographic assessment of implant stability

时间窗: 1.Pre-operative radiographic evaluation: before implant placement 2.Intra oral paralleling periapical direct digital radiographic procedure: immediately after placement and after four months

1. Pre-operative radiographic evaluation: After a healing period of four months, all the patients evaluated by Scanora 3D Cone Beam Computed Tomography scanner (CBCT) for evaluation bucco-lingual dimention, mesio-distal width, relation to neighbouring vital structures, bone density and assessment good position for implant placement. Post-operative Digital Radiography Assessment: 2. Intra oral paralleling periapical direct digital radiographic procedure: Indirect Standardized digital radiographs were achieved using KaVo Scan eXam™M One and the Rinn extension cone paralleling (XCP) periapical film holder. The KaVo Scan eXam™M One is an Intraoral digital imaging plate system (psp) system using Imaging plate which is a film-like thin, flexible, and wireless phosphorescent plate, which works as a wireless receptor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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