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临床试验/CTRI/2025/12/098443
CTRI/2025/12/098443尚未招募不适用

Effect of two different Antioxidant therapies on the implant stability and crestal bone loss in smokers and non-smokers: A Randomized Controlled Trial

Dr Rajlakshmi Banerjee1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月15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
60
试验地点
1
主要终点
To comparatively evaluate the effect of two different antioxidants on the stability of implants and crestal bone loss in smokers and nonsmokers

研究概览

简要总结

The use of osseointegrated implants as a foundation for the prosthetic replacement of missing teeth has become widespread in the last decade.1 Owing to the remarkable success of dental implants, there has been growing interest in identifying factors associated with implant failure. Given the well-documented deleterious effect of smoking on wound healing after tooth extraction and its association with poor quality bone and periodontal disease, a negative effect of tobacco use on implant success is to be expected. Oxidative stress occurs as a result of an overproduction of ROS (reactive oxygen species) not balanced by an adequate level of antioxidants. ROS are highly reactive molecules which consist of a number of diverse chemical species, including radical and non-radical oxygen species. Many diseases have been linked to oxidative stress including bone diseases among which one of the most important is the osteoporosis. Changes in ROS and/or antioxidant systems seem to be involved in the pathogenesis of bone loss. ROS induce the apoptosis of osteoblasts and osteocytes, and this favours osteoclastogenesis and inhibits the mineralization and osteo-genesis. Antioxidants either directly or by counteracting the action of oxidants contribute to activate the differentiation of osteoblasts, mineralization process and the reduction of osteoclast activity. In fact, a marked decrease in plasma antioxidants was found in aged or osteoporotic women. Therefore, this study was planned to address the gap in knowledge as to whether antioxidant therapy can improve implant stability and reduce crestal bone loss in smokers and non-smokers receiving implant treatment

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
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients in the age group of 20-40 years with history of smoking less than 10 cigarettes per day Patients in the age group of 20-40 years with no history of smoking Patients with no other history of systemic complications other than the history of smoking Patients willing to replace missing teeth with implants Patients indicated for implant placement with healing abutment in single stage.
  • Patients willing to take part in the study.

排除标准

  • Patients with other systemic complications like diabetes and other medical conditions other than history of smoking Patients with the history of smoking not willing to follow protocol for implant placement Patients indicated for two stage implant surgery will be excluded.
  • Patients requiring soft or hard tissue augmentation will be excluded from the study.
  • Patients not willing to take part in the study.

结局指标

主要结局

To comparatively evaluate the effect of two different antioxidants on the stability of implants and crestal bone loss in smokers and nonsmokers

时间窗: 0 months, 3 months and 6 months

次要结局

未报告次要终点

研究者

发起方
Dr Rajlakshmi Banerjee
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rajlakshmi Sujoy Banerjee

RDDC and Research centre (VSPM DCRC)

研究点 (1)

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