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临床试验/NCT06123221
NCT06123221招募中不适用

COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.

Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
38
试验地点
2
主要终点
Pain level

研究概览

简要总结

This study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultaneously using the lateral window technique (lSFE) with sinus lift. A blind, randomized, controlled clinical trial will be carried out with individuals over 18 years old, and with single tooth loss in the posterior maxilla, where the residual bone height (RBH) is 3 to 5 mm. The tSFE will be performed with osseodensification burs (Densa Bur, Versah, USA) using a counterclockwise motion, associated to synthetic biomaterial (hydroxyapatite and beta-tricalcium phosphate). The lSFE technique will require the sinus to be filled with the same biomaterial as the group using the other technique, and the antrostomy to be covered with a polydioxanone-based membrane. The patient's post-operatory perceptions will be evaluated by self-administered questionnaires quantifying social and professional isolation, physical appearance, duration and changes in quality of life, eating and speech, diet variations, and sleep deficiency for 2 weeks after the procedure. Pain will be assessed with the visual analogue scale (VAS). Immediately after prosthetic rehabilitation, cone beam tomography will be performed. Controls at 6 and 12 months will be performed. In these images, the marginal bone level in relation to a fixed reference point on the implants (upper part of the platform) will be measured mesially and distally in each implant, using a specific program (ImageJ - version 1.49v / NIH software - Bethesda, MD, USA). Generalized estimating equations will be used to compare the two treatments overtime. The significance level used will be 0.05.

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 (Investigator)

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

  • Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm;
  • Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm;
  • Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated;
  • Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable plastic expansion;
  • Patients with adequate interarch space for placement of the prosthetic crown;
  • Good physical health status (ASA1 and ASA2, according to the Physical Status Classification System - American Society of Anesthesiologists);
  • At least 6 months since the last tooth loss in the region to be operated;

排除标准

  • - Those with sinus pathology;
  • Heavy smokers (more than 10 cigarettes a day);
  • Those with a history of head and neck radiotherapy;
  • Those who have already undergone bone augmentation in any of the targeted surgical areas;
  • Immunodeficiency of any nature;
  • Emotional instability and psychiatric problems;
  • Pregnancy;
  • Current use of oral bisphosphonates or history of using injectable bisphosphonate;
  • Patients with active periodontitis defined by the presence of subgingival bleeding greater than 10%;
  • Documented allergy to drugs or dental materials involved in the experimental protocol.

结局指标

主要结局

Pain level

时间窗: day 14

visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

次要结局

  • Medication Diary (number of doses of Ibuprofen 600mg)(day 14)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Nogueira Haas

Professor

Federal University of Rio Grande do Sul

研究点 (2)

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