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临床试验/CTRI/2024/09/073784
CTRI/2024/09/073784尚未招募不适用

A COMPARATIVE EVALUATION OF THE EFFECTS OF OZONATED WATER AND NORMAL SALINE IRRIGATION ON DENTAL IMPLANTS PLACED USING OSSIODENSIFICATION AND CONVENTIONAL DRILLING PROTOCOL- AN IN-VIVO STUDY

Krishna Vishwa Vidhyapeet1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年10月5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
84
试验地点
1
主要终点
To determine the primary implant stability quotient (ISQ) values of dental implants placed with Osseodensification and conventional protocol using normal saline and ozonated water as an irrigant

研究概览

简要总结

Dental implants, in today’s world are considered one of the best alternatives for replacement of missing teeth, showing better results in esthetics and function. The success rate of dental implants depends largely on the quality of bone present and the ridge, the sterilization protocol, which may come as a challenge to the implantologist. Implants placed in poor quality bone are often related to compromised stability and poor Osseointegration.

 Osseodensification technique, could increase primary stability of dental implantsin poor quality bone. This procedure is characterized by low plastic deformation ofbone that is created by rolling and sliding contact using a densifying bur (Densahâ„¢ burs) that is fluted such that OD does not excavate bone but simultaneously compactsand autografts the particulate bone in an outward direction to create theosteotomy, thereby preserving vital bone tissue and densifying the bone at the site.

 Ozone is known to react as an antioxidant, able to promote homeostasis, enhance local oxygen supply and elicit bactericidal effect particularly on staphylococcal and streptococcal infections. Previous literature has showed that ozone readily penetrates through the tissue, eliminates any bacterial, fungal and viral contamination.The application of ozone in oral surgery has an attempt to disinfect the oral cavity prior to surgery. Creating a sterile surgical environment in the oral cavity would be a desirable prerequisite for implant surgery. To get some way towards this goal, a sterile implant site is achieved by irrigating ozone water(25 μg/ml) during surgery. This would also promote healing and stimulate the immune system.

 Resonance frequency analysis (RFA) is a non-invasive technique that gives a clinical measure of stability and presumed osseointegration of the placed implant.Assessment of inflammation through inflammatory biomarker C-Reactive Protien(CRP) with Interpretation of CRP levels will be done one day before (preoperative) the implant placement and after 48 h (postoperative) of implant placement in both the groups

The experimental design consists of

Group A – Implants placed using conventional implant technique

·          Sub group 1- irrigation done using normal saline

·         Sub group 2- irrigation done using ozonated water(25 μg/ml)

 Group B – Implants placed using osseodensification technique

·         Sub group 3- irrigation done using normal saline

·         Sub group 4- irrigation done using ozonated water(25 μg/ml)

All the groups will be subjected to Resonance Frequency Analysis(RFA) to determine the implant stability quotient (ISQ) during Implant placement.

 The crestal bone loss of the groups will be radiographically determined at

1.      Implant placement

2.      After 6 months

3.      After 12 months

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Two or more missing teeth in posterior maxilla Adequate bone height, width and optimal bone density Patient’s physical status, ASA Classes I and II.

排除标准

  • Undermined systemic disorders and immunosuppressed patients and patients with uncontrolled hypertension or diabetes.
  • Patients smoking more than 5 cigarettes/day and who have a history of alcoholism/drug abuse during last 5 years.
  • Patient with history of chemotherapy or radiation for the last 12 months.
  • Poor oral hygiene and severe or uncontrolled periodontitis.

结局指标

主要结局

To determine the primary implant stability quotient (ISQ) values of dental implants placed with Osseodensification and conventional protocol using normal saline and ozonated water as an irrigant

时间窗: 2 days, 15 days and 2 months

次要结局

  • To compare the primary implant stability (ISQ) values derived from Osseodensification protocol & conventional protocol using ozonated water & normal saline as irrigant(2 days ,15 days & 2 months)

研究者

发起方
Krishna Vishwa Vidhyapeet
申办方类型
Other [Deemed University]
责任方
Principal Investigator
主要研究者

Dr Shubha Joshi

Krishna Vishwa Vidhyapeet Deemed to be University

研究点 (1)

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