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临床试验/CTRI/2024/06/069247
CTRI/2024/06/069247尚未招募不适用

Comparative Evaluation Of Implant Stability, Gingival Soft Tissue And Marginal Bone Level In Emdogain Treated And Conventional Implants :Randomized Controlled Clinical Study

Dr Mitali Niras1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年8月1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
15
试验地点
1
主要终点
Implant stability and Gingival soft tissue and Marginal bone level

研究概览

简要总结

This is a randomized, double blind, controlled clinical study comparing and evaluating the implant stability  with the help of Resonance frequency analysis  and gingival soft tissue (plaque index, bleeding index, probing depth, pink esthetic score) with the help of plastic periodontal probe and marginal bone level with the help of IOPA in emdogain treated implants versus conventional implants. Emdogain is used to improve the soft and hard tissue healing. in this study emdogain is going to be coated on implant before placement of implant on one side of the arch and on the other side of the same arch conventional implant will be placed. participant consent form will be provided to the patients in the simplified language. The study would be conducted for 1 year in 15 patients in India. The primary outcome of this study such as Implant stability will be measured at baseline, 3 months, 6months and 12months and gingival soft tissue, marginal bone level will be measured at 3 months, 6months and 12months. results will be compared statistically.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1 age above 18 years 2 Able to provide consent 3 Patient needs implants in 2 areas in the same arch.

排除标准

  • 1 Patients with medical history in which any dental intervention would be contraindicated 2 Patients with any local or systemic disease condition or medication that might compromise health of the periodontium 3 Pregnant and lactating women 4 Current chemotherapy radiotherapy or drugs that interfere with study 5 Patients who are not willing to sign the consent form.

结局指标

主要结局

Implant stability and Gingival soft tissue and Marginal bone level

时间窗: Implant stability at baseline 3 months, 6 months and 12 months gingival soft tissue and marginal bone level at 3 months, 6 months and 12 months

次要结局

未报告次要终点

研究者

发起方
Dr Mitali Niras
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mitali Niras

K M Shah dental college and hospital

研究点 (1)

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