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临床试验/CTRI/2019/03/018286
CTRI/2019/03/018286尚未招募不适用

Comparative evaluation of hardtissue and soft tissue responsearound Zirconium and Titaniumimplants using CBCT andultrasound Doppler flowmetry.

korada sai sirisha1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月4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
20
试验地点
1
主要终点
immeditely after implant placement

研究概览

简要总结

Titaniumhas become a gold standard as a base for implant placement. Thenewly emerging Zirconia implants are bio compatible and mechanically stable. Conebeam Computed tomography (CBCT) can be used for the objective quantification ofdirect density measurements of bone, expressed in Hounsfield units (HU) andbonequality changes by fractal dimension analysis.

Doppler ultrasonographyis a non-invasive, accurate and simple technique to measure continuousmicrocirculatory blood flow in  peri- implant soft tissues .Theobjectives of this study:To compare andevaluate   bonemineral density in Hounsfield units (HU) in Zirconium and Titanium implants .  Tocompare and evaluate trabecular bone microstructure by Fractal Dimension(FD) in Zirconium and Titaniumimplants.  To compare evaluate crestal bone loss in Zirconium and Titanium dentalimplants. To compare peri-implant vascularity of Zirconium and Titanium dental implants. Patients attending outpatient department of  Periodontics St Joseph Dental College (SJDC). Patientsin mean age group between 25 to 55 years and partially edentulous areas will berandomly selected for double blind clinical trial. 20 implants will be placed usingroll of dice method . All the patients will be assessed for Bone MineralDensity (BMD) in Hounsfield units (HU) and Trabecular bonemicrostructure by Fractal Dimension (FD) analysis using CBCT and crestal bone loss using RVG aroundZirconium and Titanium implants at baseline and one year after placement ofimplants.

Vascularflow in peri-implant mucosa will also be assessed by ultrasound Dopplerflowmetry at baseline (before placement of the Implant) and on the 10th daypost operatively.

Inclusioncriteria:

•       Patients of mean agegroup between 25 to 55 years.

•       Patients with one or moreedentulous site in either maxilla or mandible.

•       Good systemic health.

          Exclusioncriteria:

•      Any systemic disease thataffects the periodontium are contraindicated for implant placement.

•      Patients with psychiatricdisorders.

•      Inability orunwillingness to complete the trial

•      Poor oral hygiene

•      Pregnant,lactating mothers.

•      Historyof smoking and alcohol

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • adult males or females with one or more edentulous site in either maxilla or mandible and patients with good systemic health.

排除标准

  • any systemic illness that effects periodontium are contraindicated for implant placement.patients with psychiatric disorders.inability or unwillingness to complete the trial.poor oral hygiene.
  • pregnant, lactating mothers.
  • history of smoking and alcohol.

结局指标

主要结局

immeditely after implant placement

时间窗: base line and after 10 days

次要结局

  • after osseointegration of implants(after 12 months)

研究者

发起方
korada sai sirisha
申办方类型
Other [other]

研究点 (1)

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