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临床试验/CTRI/2025/04/084932
CTRI/2025/04/084932尚未招募不适用

Evaluation of the Effect of Ozonated olive oil on Soft tissue and Hard tissue changes around Non submerged Dental Implant

Sandra Haritha1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年1月6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
22
试验地点
1
主要终点
To evaluate the wound healing around implants coated with ozonated olive oil.

研究概览

简要总结

This study is an randomiz ed clinical trial comparing the effects of Ozonated olive oil on hard tissue and soft tissue changes around non submerged dental implants After patient selection based on eligibility criteria ,Phase1 therphy oral prophylaxis and surgical stunt fabrication will be done and patient will be recalled after 1week.The procedure will be performed under local anesthesia using 2%lignocaine containing adrenaline in 1:80,000 ratio .A mid crestal incision will be given and osteotomy site will be prepared.   In Group1 implants without Ozonated olive oil will be placed .In Group 2 Implants coated with Ozonated olive oil will be placed.After placement stability will be checked with resonance frequency analysis at baseline .Healing abutment will be placed and flaps will be approximated and sutured. Patient will be recalled after 1st week,2nd week for evaluating wound healing 3months and 6months for crestal bone level and 3months for implant stability.

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.Individuals with an age group of 20-60 years of either gender 2.Presence of adequate horizontal(4-5mm) and vertical (12mm) dimensions of the alveolar bone based on CBCT.
  • 3.Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
  • 4.Apparently healthy individuals.
  • 5.Individuals with bone density classified as D2 and D3 type of bone.

排除标准

  • 1.Any forms of tobacco users.
  • 2.Pregnant and lactating women.
  • 3.Subjects taking any medication which effect healing and bone metabolism.
  • 4.Individuals with parafunctional habits.
  • 5.History of radiotherapy to head and neck.

结局指标

主要结局

To evaluate the wound healing around implants coated with ozonated olive oil.

时间窗: 1st week &2nd week after surgery

次要结局

  • To evaluate the crestal bone level around implants coated with ozonated olive oil.(Baseline ,3 months and 6 months)
  • To evaluate Implant stability around implants coated with Ozonated olive oil(Baseline and 3months.)

研究者

发起方
Sandra Haritha
申办方类型
Other [self]

研究点 (1)

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