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临床试验/CTRI/2017/11/010393
CTRI/2017/11/010393进行中(未招募)2 期

Comparative Evaluation of Mandibular Posterior Residual Ridge Resorption in Patients Rehabilitated with Conventional Dentures And two anterior Implant - Supported Mandibular Overdentures -An Invivo Study

Dr Ch Praveena1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年7月19日最近更新:

试验速览

阶段
2 期
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Bone loss

研究概览

简要总结

A total of 20 completely edentulouspatients (male & female) of age group 40-65 years will be selected based onthe clinical & radiographic examination. All the patients will be grouped into 2groups.

Group 1: 10 completely edentulous patients to be rehabilitatedwith conventional dentures.

Group 2: 10 completely edentulous patients to berehabilitated with two implant-supported overdentures placed in theinterforaminal region.

New complete dentures will befabricated for both group A & group B patients .Later, in group B patients, two single stage endosseous implants will be placed bilaterally in theinterforaminal region of the mandibular arch. The implants will be loaded with mandibular denture two weeks after theimplant placement. Panoramic radiographs for both group A &group B patients will be taken and compared to ascertain the possible bone loss at baseline,3 & 6 months.The method consisted of proportional area measurements of theposterior mandible. The change in Posterior Area Index (PAI) is calculated forboth the groups.

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 and Investigator Blinded

入排标准

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

入选标准

  • Edentulous period of 3-6 months .
  • Absence of any systemic diseases.
  • Moderate resorption of the mandible (mandible height in the symphysis region between 12 and 18 mm).
  • Adequate inter-arch space of 16-22 mm.
  • Bone density of type 1, 2 &3.

排除标准

  • A medical & personal history that would complicate the outcome of the study.
  • Patients with type 4 bone density.
  • Heavy smokers.
  • Poorly controlled Diabetes Mellitus.
  • Patients with a history of radiotherapy in the head and neck region.
  • Patients with a history of pre-prosthetic surgery.

结局指标

主要结局

Bone loss

时间窗: 3, 6 months

次要结局

未报告次要终点

研究者

发起方
Dr Ch Praveena
申办方类型
Other [self]

研究点 (1)

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