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临床试验/NCT02507661
NCT02507661已完成4 期

Esthetic Outcomes of Implant-supported Crowns After Alveolar Ridge Preservation With Beta Tricalcium Phosphate and Collagen in the Maxillary Esthetic Zone

University of Belgrade1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
implant stability analysis at the time of implant placement

研究概览

简要总结

The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy patients according to Classification of American Society of Anesthesiologists (ASA I)
  • presence of 4 socket walls
  • non-smokers
  • good oral hygiene
  • good occlusion

排除标准

  • patients with alveolar ridge height less than 12 mm
  • presence of acute or chronic oro-facial pain
  • acute periapical infection
  • injured soft tissue
  • patients who had dental interventions in last 7 days
  • patients who had any medications within last 24 hours
  • patients with bruxism and para-functions
  • patients with allergies to any of applied materials

研究组 & 干预措施

alveolar ridge preservation - 2 months

Experimental

preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months

干预措施: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months (Drug)

no-preservation of alveolar ridge - 2 months

Active Comparator

no-preservation of alveolar ridge - 2 months

干预措施: no-preservation of alveolar ridge - 2 months (Drug)

preservation of alveolar ridge - 4 months

Experimental

preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months

干预措施: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months (Drug)

no-preservation of alveolar ridge - 4 months

Active Comparator

no-preservation of alveolar ridge - 4 months

干预措施: no-preservation of alveolar ridge - 4 months (Drug)

preservation of alveolar ridge - 9 months

Experimental

preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months

干预措施: preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months (Procedure)

no-preservation of alveolar ridge - 9 months

Active Comparator

no-preservation of alveolar ridge - 9 months

干预措施: no-preservation of alveolar ridge - 9 months (Drug)

结局指标

主要结局

implant stability analysis at the time of implant placement

时间窗: baseline

Implant stability will be measured by the resonance frequency analysis

implant stability analysis 3 weeks after implant placement

时间窗: baseline, 3 weeks

Implant stability will be measured by the resonance frequency analysis

implant stability analysis 6 weeks after implant placement

时间窗: baseline, 6 weeks

Implant stability will be measured by the resonance frequency analysis

implant stability analysis 8 weeks after implant placement

时间窗: baseline, 8 weeks

Implant stability will be measured by the resonance frequency analysis

change in pink and white esthetic score 2 months of loading

时间窗: 2 months

Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns

change in pink and white esthetic score 6 months of loading

时间窗: 6 months

Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns

change in pink and white esthetic score 12 months of loading

时间窗: 12 months

Pink esthetic scale and white esthetic scale will be used for evaluation of changes in white and pink esthetic parameters for implant-supported crowns

次要结局

  • analysis of new bone formation 2 months after preservation of alveolar ridge(2 months)
  • analysis of new bone formation 4 months after preservation of alveolar ridge(4 months)
  • analysis of new bone formation 9 months after preservation of alveolar ridge(9 months)

研究者

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

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD Professor

University of Belgrade

研究点 (1)

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