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临床试验/NCT03973190
NCT03973190Unknown不适用

Evaluation of Bone Quality and Primary and Secondary Stability of Implants Installed in Alveolar Regeneration Area by Three Different Techniques

Federal University of Juiz de Fora2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018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
发起方
入组人数
30
试验地点
2
主要终点
ISQ analysis

研究概览

简要总结

The objective of this randomized controlled clinical study was to compare bone quality between three different alveolar ridge preservation methods, also with the evaluation of primary and secondary dental implant stabilities at these sites.

详细描述

In the present study will be collected 24 patients, with indication of extraction of premolars or upper incisors. All participants will sign a Free and Informed Consent Form (TCLE), agreeing to participate voluntarily in this research.

Patients were randomly allocated into three groups according to the following treatments:

Group RET: Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury.

SBC Group: Fill bone alveolus with Bone Ceramic® graft (Straumann AG, Basel, Switzerland) and cover it with palatal flap according to the technique of Khoury.

PRO Group: Alveolus sealing by a temporary ovoid pony of acrylic resin.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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

  • Extraction of premolars
  • Canines or incisors
  • Having two adjacent teet
  • Due to root fracture
  • Extensive cavities that do not allow restorative treatment and / or unfavorable -endodontic prognosis
  • Systemically healthy

排除标准

  • Patients who use any drug that influences bone metabolism
  • Patients with a history of head and neck radiotherapy
  • Patients undergoing chemotherapy for the treatment of malignant tumors at the time of the study
  • Patients with severely resorbed alveoli

研究组 & 干预措施

RET Group

Placebo Comparator

Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000).

干预措施: Immediate alveolar regeneration after exodontia (Procedure)

RET Group

Placebo Comparator

Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000).

干预措施: installation of dental implant and collection of biological material (Procedure)

RET Group

Placebo Comparator

Closure of the alveolus by first intention through palatal flap sliding according to the technique of Khoury et al. (2000).

干预措施: ISQ analysis (Device)

SBC Group

Active Comparator

Fill bone alveolus with Bone Ceramic® graft (Straumann AG, Basel, Switzerland) and cover it with palatal flap according to the technique of Khoury et al. (2000).

干预措施: Immediate alveolar regeneration after exodontia (Procedure)

SBC Group

Active Comparator

Fill bone alveolus with Bone Ceramic® graft (Straumann AG, Basel, Switzerland) and cover it with palatal flap according to the technique of Khoury et al. (2000).

干预措施: installation of dental implant and collection of biological material (Procedure)

SBC Group

Active Comparator

Fill bone alveolus with Bone Ceramic® graft (Straumann AG, Basel, Switzerland) and cover it with palatal flap according to the technique of Khoury et al. (2000).

干预措施: ISQ analysis (Device)

PRO Group

Active Comparator

Alveolus sealing by a temporary ovoid pony of acrylic resin.

干预措施: Immediate alveolar regeneration after exodontia (Procedure)

PRO Group

Active Comparator

Alveolus sealing by a temporary ovoid pony of acrylic resin.

干预措施: installation of dental implant and collection of biological material (Procedure)

PRO Group

Active Comparator

Alveolus sealing by a temporary ovoid pony of acrylic resin.

干预措施: ISQ analysis (Device)

结局指标

主要结局

ISQ analysis

时间窗: up to the conclusion of the study, an average of 2 years

result and closer Immediate / at the time of surgery (values from 0-100) where 0 is closest if zero is worse the to 100 the better.After 7 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better. After 7 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better. After 30 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better. After 60 days (values from 0-100) where 0 is the closest to zero the result is worse and closer to 100 the better.

次要结局

未报告次要终点

研究者

发起方
Federal University of Juiz de Fora
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bruno Salles Sotto-Maior

Principal investigator

Federal University of Juiz de Fora

研究点 (2)

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