跳至主要内容
临床试验/CTRI/2025/02/080479
CTRI/2025/02/080479尚未招募不适用

Comparative evaluation of immediate versus delayed loading on peri-implant bone levels and tgf-alpha levels in peri-implant crevicular fluid - A clinico-biochemical study

SHREYA MISHRA1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年2月24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
16
试验地点
1
主要终点
To evaluate and compare levels of TGF –alpha in PICF around immediate and delayed loaded implants at 15 days, 1 month and at 3 months and to evaluate and compare the marginal bone loss at baseline to 3 months

研究概览

简要总结

Introduction - According to Albrektsson (1993), a successful implant should sustain less than 1.5 mm of bone loss during the first year and less than 0.2mm annually thereafter. The assessment of marginal bone loss around implants is carried out by means of periapical radiographs and more recent advances like cbct. Another important aspect is primary and secondary implant stability. Primary implant stability directly dependents on bone quality. A promising tool for assessing peri-implant bone formation is the detection of specific biomarkers in peri-implant crevicular fluid. Tgf-alpha is an important biomarker during the first stages of osseointegration, a fibrin-rich vascularized matrix populated by fibroblast-like cells is created providing a template for future bone.

Aim - the aim of this present study is to evaluate and compare the peri-implant bone loss between immediate and delayed loaded implants.

Materials & methods - For group a, 8 sites indicated for replacement of missing tooth with more than 6mm width and 10mm height of bone will be taken for implant placement with immediate loading followed by placement of healing abutment. Acrylic crown will be placed within 72hrs. For group b, 8 sites indicated for replacement of missing tooth with sufficient height of bone will be taken for implant placement with delayed loading followed by placement of healing abutment. Picf samples will be collected at 15 days, 30 days and 90 days. Isq and crestal bone levels will be measured at baseline and 3 months.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Subjects aged above 18 years requiring Implant placement.
  • Patients with adequate oral hygiene status
  • No active periodontal disease
  • Sufficient bone quality (D1, D2 and D3) and quantity
  • Proper inter-occlusal space in missing tooth region
  • Patients who are willing to comply with the treatment protocol
  • Extraction must be done at least 3 months prior to treatment.

排除标准

  • Patients with uncontrolled diabetes.
  • Patients with autoimmune diseases, psychiatric disorders, osteoporosis
  • Patients undergoing or who underwent radiation therapy and chemotherapy to the head and neck region during the last 12 months
  • Patients with poor oral hygiene
  • Alcoholic, drug abusers and heavy smokers
  • Pregnant and lactating women
  • Sites with acute infection.

结局指标

主要结局

To evaluate and compare levels of TGF –alpha in PICF around immediate and delayed loaded implants at 15 days, 1 month and at 3 months and to evaluate and compare the marginal bone loss at baseline to 3 months

时间窗: Baseline- 3 months

次要结局

  • Comparision of bleeding on probing and ISQ measurements between immediate and delayed loaded implants at baseline and 3 months.(Baseline- 3 months)

研究者

发起方
SHREYA MISHRA
申办方类型
Other [PRIVATE DENTAL COLLEGE]
责任方
Principal Investigator
主要研究者

SHREYA MISHRA

ITS DENTAL COLLEGE

研究点 (1)

Loading locations...

相似试验