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临床试验/CTRI/2025/05/087474
CTRI/2025/05/087474尚未招募Unknown

Comparative evaluation of crestal bone loss around dental implant with and without coating of Recombinant Human Bone Morphogenic Protein-2 (rhBMP-2): A Clinico Radiographic CBCT study

Dr Anuradha Mehra1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Crestal Bone Loss Around Dental Implants

研究概览

简要总结

In this study we will be randomly selecting 20 patients according to the inclusion and exclusion criteria. 10 patients will be in the test group, where implants will be coated with rhBMP-2 prior to their placement into the osteotomy site. The other 10 patients will be the control group, where the implants will be without the coating of rhBMP-2. At baseline RVG and CBCT will be recorded. The patients will then be re-called after 4 months, and again after 9 months, when the RVG and CBCT will be repeated and the data will be collected. The data of both groups will be statistical analysed for obtaining the final results and drawing conclusions.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients having single missing tooth with an adequate width and height of edentulous space available for placement of implant.
  • Edentulous sites in mandibular and maxillary arches.
  • Adjacent teeth intact; restored with functionally & esthetically good restorations; restored with prosthesis precluding the addition of the missing tooth.
  • Patients with good periodontal and general health.

排除标准

  • Patients who are unable to perform routine oral hygiene procedures.
  • Patients with history of smoking.
  • Patients with TMJ disorders.
  • Patients with dental history of bruxism and parafunctional habits or deep bite cases.
  • History of substance abuse.
  • Insufficient vertical inter arch space to accommodate the prosthodontic components available, together with a proposed pontic and occasional gingival analogue designs.
  • Patients with uncontrolled diabetes.
  • Absence of opposing occlusion.

结局指标

主要结局

Crestal Bone Loss Around Dental Implants

时间窗: At Baseline 4 Months 9 Months

次要结局

  • Soft Tissue Changes Around The Dental Implant(At Baseline 4 Months 9 Months)

研究者

发起方
Dr Anuradha Mehra
申办方类型
Other [self]

研究点 (1)

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