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临床试验/NCT05513170
NCT05513170Unknown不适用

Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Measurement of Bone Change in Cone Beam CT

研究概览

简要总结

Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.

详细描述

The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.

Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.

The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.

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)

盲法说明

This trial is considered a randomized double blind clinical trial due to the following:

  1. The participant will be blinded to the technique that will be used during the surgical operation.
  2. The outcome assessor will be blinded
  3. The operator (DR.B.S.) will not be blinded for both techniques during the surgical operation, as the two techniques are different. (Dr. M.O.).

The purpose of double blinding procedure is to reduce assessment bias and to increase accuracy and objectivity of clinical outcomes

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No inflamed sinus
  • Minimum alveolar ridge height 5-6 mm
  • Medical free
  • Both genders males and females.

排除标准

  • Remaining alveolar ridge height is less than 5mm
  • Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Patients having history of allergy to any drugs.
  • Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.

结局指标

主要结局

Measurement of Bone Change in Cone Beam CT

时间窗: three and six months

The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.

次要结局

  • Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)(At the day of implant placement and after six months)

研究者

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

Basma Mohamed Abdelfatah Mohamed Shaheen

Doctor of Dental Surgery

Cairo University

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