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临床试验/NCT05735613
NCT05735613已完成不适用

The Efficacy of Different Techniques of Crestal Sinus Lifting to Place Dental Implant Into Prosterior Maxilla of Deficient Height: Randomised Clinical Trial

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
maxillary sinus augmentation

研究概览

简要总结

Twenty one patients with deficient posterior maxilla and alveolar bone height ≤ 5mm were included.Those patients randomly divided into 3 equal groups:

  1. Group 1: 7 patients treated by osteotome closed sinus lift with bone grafting (xenograft) and implant placement.
  2. Group 2: 7 patients treated by densah burs(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement.
  3. Group 3: 7 patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.

详细描述

Patients have been asked asked to use 0.12% chlorhexidine digluconate rinse, and Povidone iodine solution will be used to perform extraoral antisepsis. After administration of local anesthesia at the implant site, a full thickness flap was elevated to expose the crest of alveolar ridge. A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.

In group 1; (closed sinus lifting with Osteotome): The drills can be sequentially used to widen the osteotomy site to the same level (1 mm short of the sinus floor), an osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level, the osteotome will be tapped gently to fracture up the sinus floor.

In group 2; (closed sinus lifting with densah drills): Change the drill motor to reverse-densifying Mode (counterclockwise drill speed 800-1500 rpm with copious irrigation), Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor, use the next wider Densah Bur (3.0mm) in the same mode and advance it into the previously created osteotomy with modulating pressure and a pumping motion. When feeling the haptic feedback of the drill reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments, the next wider densah drills advance in the osteotomy.

In group 3: The initial osteotomy will be performed with a 2-mm twist drill to remove the cortical bone, then the intralift tips (Intralift; TKW1, TKW2, TKW3, TKW4, TKW5; Satelec). TKW1 to TKW4 tips have diameters of 1.35 mm, 2.1 mm, 2.35 mm, and 2.8 mm and will be used to gradually widen the access canal to the Schneider membrane, gentle pressure will be applied on the tips to deepen the pathway, and a sterile spray (80 mL/min) cooling the tips to avoid heat injury. The TKW5 tip will be then inserted into the access canal, and the ultrasonic activation for 5 seconds with internal irrigation of 40 mL/min and repeated at 50 mL/min and then 60 mL/min. The sinus membrane will be pushed upward by the hydraulic pressure, the floating of the sinus membrane will be evaluated, and then the TKW4 (Ø 2.8 mm) will be used again to widen the access canal to the sinus membrane before plugging the bone graft.

For all groups: Clinical check for membrane still intact, blocking the patient's nostrils and asking the patient to blow through his or her nose. Xenograft was added as the grafting material and pushed to the sinus through the osteotomy site until the desired height of sinus elevation will be gained, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Cover screw will be placed on implant and flab will be sutured. Sutures were removed after 10 days.

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
None

入排标准

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

入选标准

  • Young and adult patients of both sexes.
  • Patients exhibit class C residual bone height according to ABC sinus augmentation classification.(18)
  • The edentulous ridges are covered with mucoperiosteum free from signs of inflammation, ulceration or scar tissue.
  • Remaining natural teeth have good periodontal tissue support.
  • Occlusion showing sufficient inter-arch and intra-arch spaces for future prosthesis.

排除标准

  • Patients with systemic conditions that could influence the outcome of the therapy as: Pregnancy and Heavy smokers
  • Patients with systemic disease that may affect bone quality.
  • Uncooperative patients
  • Patients with active periodontal disease.
  • Patients with neglected oral hygiene.
  • Patients with limited mouth opening and unfavorable intermaxillary arch space.
  • Patients with maxillary sinus disease or previous sinus surgery.

结局指标

主要结局

maxillary sinus augmentation

时间窗: 6 months

evaluation of vertical bone gain using CBCT before and after six months of implant placement

dental implant stability

时间窗: 6 months

evaluation of implant primary and secondary stability clinically using ostell device through measuring ISQ value

次要结局

  • bone density(6 months)
  • crestal bone loss(6 months)

研究者

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

Ahmed Halim Hashem

assistant lecturer of periodontology and oral medicine

Al-Azhar University

研究点 (2)

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