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临床试验/CTRI/2025/06/088963
CTRI/2025/06/088963尚未招募不适用

Comparative Evaluation of Implant Stability and Bone Quality in Patients with Implants Placed in Sockets with Bone Graft against Implants Placed in naturally healed sockets-A In Vivo study

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
Comparative analysis will highlight the advantages or limitations of bone grafting in immediate implant placement.

研究概览

简要总结

INTRODUCTION Dental implants are the preferred solution for missing teeth, with implant stability and bone quality being key factors for long-term success. Bone quality, which refers to the density and structure of the surrounding bone, is essential for osseointegration, the fusion of the implant with bone. Poor bone quality can lead to implant failure or delayed healing. When bone volume is insufficient, bone grafting is often used to enhance implant stability by increasing bone volume and quality. Common graft materials include autografts, allografts, xenografts, and synthetics, each with their pros and cons. However, the need for grafting remains debated, as some studies suggest implants can achieve adequate stability without additional grafting.

This study aims to compare implant stability and bone quality in patients receiving implants in grafted sockets versus naturally healed sockets.

AIM: To assess the differences in implant stability and bone quality between implants placed in sockets with bone grafts and those in naturally healed sockets.

OBJECTIVES:

  1. Evaluate implant stability in grafted sockets with xenografts.
  2. Evaluate implant stability in naturally healed sockets.
  3. Compare bone quality between grafted and naturally healed sockets.

RATIONALE:

  1. Identify a more compatible and cost-effective graft material (osseograft).
  2. Assess whether implants have better stability in xenograft versus allograft.
  3. Examine bone quality changes after osseograft placement.

INCLUSION CRITERIA:

  1. Patients requiring single tooth implants.
  2. Sockets with sufficient bone volume for implant placement.
  3. Non-smokers and systemically healthy individuals.

EXCLUSION CRITERIA:

  1. Systemic conditions affecting bone metabolism.
  2. Sockets with active infection or significant defects.

MATERIAL AND METHODOLOGY:

  • Group A: 22 patients with naturally healed sockets. Implants placed, and peri-implant stability tested.
  • Group B: 22 patients with xenograft augmentation in single extraction sockets. Implants placed after 6 months of grafting, followed by peri-implant testing.
  • Perio test values will be compared between both groups.

Study Design: Randomized controlled trial Study Period: 1 year Sample Size: 44 patients, divided into two groups of 22 each.

EXPECTED OUTCOMES: Better implant stability and bone quality are expected in grafted sockets due to enhanced bone volume preservation. The comparative analysis will highlight the effectiveness of grafting in immediate implant placement.

SIGNIFICANCE OF THE STUDY: This research will provide insights into the role of bone grafting in implant success and help refine clinical guidelines for implant placement, improving patient outcomes.

CONCLUSION: Optimizing implant protocols and understanding the influence of bone grafting (osseograft) are crucial for implant success. Socket grafting with materials like xenograft could improve bone quality and support predictable implant placement in sites with poor bone quality, possibly allowing for the modification of healed sites for better implant outcomes.

研究设计

研究类型
Interventional

入排标准

年龄范围
15.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients Requiring Single Tooth Implants and Sockets With Adequate Bone Volume for Implants and Nonsmokers Systemically Healthy Individuals.

排除标准

  • •Patients With Systemic Conditions Affecting Bone Metabolism and Sockets with Active Infection or Significant Bone Defects.

结局指标

主要结局

Comparative analysis will highlight the advantages or limitations of bone grafting in immediate implant placement.

时间窗: 12 weeks

Improved implant stability and enhanced bone quality are anticipated in graft (osseograft) sockets due to better preservation of bone volume and integration.

时间窗: 12 weeks

次要结局

  • To compare the bone quality at implant sites in grafted against a naturally healed socket(after 3 months of bone graft placement implant will be placed)

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college

研究点 (1)

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