跳至主要内容
临床试验/CTRI/2025/07/091461
CTRI/2025/07/091461尚未招募不适用

Evaluation of efficacy of placing delayed dental implant following “Ice-cream Cone Technique” of socket preservation using Autologous Heat Compressed Platelet-rich-fibrin (PRF) membrane with Bone Allograft compared to Collagen Membrane with Bone Allograft: A Randomized Controlled Study.

Government Dental College And Research institute Bangalore1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年7月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
1 Dimensional changes (soft tissue and hard tissue) from baseline to 4 months post-operatively between 3 groups as assessed by intra-oral scanner and CBCT

研究概览

简要总结

Participants who satisfy the eligibility criteria will be alloted after randomisation into three groups. the first group will undergo ice cream cone technique of socket preservation with autologous heat compressed prf membrane and DFDBA bone graft. the second group will be treated with ice cream cone technique of socket preservation with resorbable collagen membrane  and dfdba bone graft. third group will be followed up to observe the natural healing of the extraction socket , the primary outcome would be to asses the change in the bucco-lingual dimension of the extraction socket following interventions in all three groups along with the assesment of feasibility of placing dental implant post socket preservation without the need for ridge augmentation procedure. clinical measurment of ridge dimensions will be made with intraoral scanner , radiographic measurement will be made with cbct. histological anlyasis of preserved socket bone and patient centered outcome in all thee groups will be assesed as secondary outcome. comparision of results will be made between all three groups.

autologous heat compressed prf membrane has been used as barrier membrane because of its increased time of biodegradation and if the results of this study prove that autologous heat compressed membrane is as efficacious as resorbable  collagen membrane in socket preservation then it will be cost effective for patient undergoing socket preservation following extraction as the prf membrane derived from patient own blood.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1 ASA Physical status I & II 2 Type 2 extraction socket of non-molar tooth with at least 50 percent intact buccal bone plate and the remaining three walls are intact with adjacent teeth in good periodontal health.

排除标准

  • 1 Participants taking medication influences the bone metabolism and bone healing.
  • 2 Participants with the habit of smoking.
  • 3 Participants in which tooth is extracted due to periodontal breakdown.
  • 4 Participants with acute infection (or presence of pus) in or close to the site intended for extraction.
  • 5 Participants with occlusal disharmony.
  • 6 Pregnant and Lactating mothers.
  • 7 Participants with poor oral hygiene.

结局指标

主要结局

1 Dimensional changes (soft tissue and hard tissue) from baseline to 4 months post-operatively between 3 groups as assessed by intra-oral scanner and CBCT

时间窗: 1 at Baseline | 2 4 months after performing the procedure

2 Feasibility of placing an implant in a prosthetically driven position along with achieving the primary stability. Feasibility of implant placement is defined as “achieving primary stability following implant placement in a prosthetically guided position with 1mm of residual bone circumferentially surrounding the implant”.

时间窗: 1 at Baseline | 2 4 months after performing the procedure

次要结局

  • • Dimensional changes (soft tissue and hard tissue) from baseline to 4 months post-operatively between 3 groups as assessed by intra-oral scanner and CBCT(• Feasibility of placing an implant in a prosthetically driven position along with achieving the primary stability. Feasibility of implant placement is defined as “achieving primary stability following implant placement in a prosthetically guided position with 1mm of residual bone circumferentially surrounding the implant”.)

研究者

发起方
Government Dental College And Research institute Bangalore
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Smitha K

Government dental college and research institute

研究点 (1)

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