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临床试验/CTRI/2024/04/065850
CTRI/2024/04/065850招募中不适用

Effect of photo-biomodulation on Implant stability, Bone density and Bio-chemical markers in dental implants- A randomized controlled clinical trial.

Dr L Kavya Sri1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
22
试验地点
1
主要终点
Implant stability

研究概览

简要总结

The aim of this current study is to evaluate the effect of photobiomodulation using 980nm diode laser on implant stability, bone density and bio-chemical markers levels(OPG and RANKL)around dental implants.The total sample size is 22 patients.These patients will be divided in to two groups randomly. Group-A (control) includes 22 patients in which implants will be placed in a conventional approach.Group-B(test)includes  22 patients in which implants will be placed in a conventional approach and laser irradiation using 980nm diode laser  with 6J energy/session, time of 60sec, power of 0.1W in a continuous, non-contact mode in a sweeping motion will be done immediately after osteotomy site preparation on bone, after suturing on soft tissue and after suture removal on the 7th day.The parameters being measured in both the groups are implant stability at baseline and 3 months using resonance frequency analyzer, bone density and crestal bone levels at baseline and 6 months using CBCT, bio-marker levels in PICF at 3.5 months and 6 months using ELISA kits and healing of soft tissues 1 week post-surgically using Hamzani and chaushu’s healing index.

研究设计

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

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Mandibular posterior edentulous areas 2 Age group of 20-60 years.
  • 3 Adequate depth and width of bone should be present.

排除标准

  • 1 Patients with uncontrolled systemic diseases. 2 Pregnancy or lactating women. 3 Patients under anticoagulant therapy. 4 Chronic smokers. 5 Patients with infectious diseases ( HIV, Hepatitis.
  • B,C etc ) 6 Patients under antibiotic therapy. 7 Patients undergoing radiation therapy. 8 Patients undergoing bis-phosphonate therapy.

结局指标

主要结局

Implant stability

时间窗: Implant stability at baseline and 3 months

次要结局

  • 1 Bone density(2 Bio-marker levels( OPG and RANKL))

研究者

发起方
Dr L Kavya Sri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Lakamsani Kavya Sri

Vishnu dental college

研究点 (1)

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