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临床试验/NCT07687680
NCT07687680进行中(未招募)不适用

Comparison of Ozone and Conventional Socket Disinfection in Dental Implant Placement in Terms of Primary Stability

Zeliha Başak Çakır Erdil1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2025年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
51
试验地点
1
主要终点
Primary Implant Stability (Insertion Torque)

研究概览

简要总结

This randomized split-mouth controlled clinical trial aims to compare the effects of ozone and conventional implant site disinfection on primary and early secondary implant stability. Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will receive ozone disinfection at one implant site and conventional disinfection at the paired site according to a randomized allocation. Implant stability will be assessed immediately after implant placement using insertion torque and resonance frequency analysis (Implant Stability Quotient, ISQ), and secondary stability will be evaluated by ISQ measurements at the 3-month follow-up during healing abutment placement. The study will determine whether ozone disinfection improves implant stability during the early osseointegration period.

详细描述

Primary implant stability is a key determinant of successful osseointegration and long-term implant survival. Various implant site disinfection methods have been proposed to reduce the microbial load before implant placement. Ozone possesses antimicrobial and biostimulatory properties and may improve the biological environment for implant healing compared with conventional implant site disinfection.

The purpose of this randomized split-mouth controlled clinical trial is to compare ozone implant site disinfection with conventional implant site disinfection in terms of primary and early secondary implant stability.

Systemically healthy adults requiring at least two dental implants in symmetrical or contralateral edentulous sites will be enrolled. According to a randomized split-mouth design, one implant site will receive ozone disinfection before implant placement, whereas the paired implant site will receive conventional disinfection. This design allows each participant to serve as their own control, thereby minimizing inter-individual variability.

Primary implant stability will be assessed immediately after implant placement using insertion torque measurements and resonance frequency analysis (Implant Stability Quotient, ISQ). Secondary implant stability will be evaluated by resonance frequency analysis at the 3-month follow-up during healing abutment placement. All clinical procedures will be standardized and performed by experienced clinicians. The study aims to determine whether ozone implant site disinfection provides superior implant stability during the early osseointegration period compared with conventional implant site disinfection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years or older.
  • Systemically healthy individuals requiring at least two dental implants.
  • Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
  • Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

排除标准

  • Adults aged 18 years or older.
  • Systemically healthy individuals requiring at least two dental implants.
  • Presence of symmetrical or contralateral edentulous sites suitable for dental implant placement.
  • Adequate bone volume for implant placement without the need for simultaneous bone augmentation.
  • Ability and willingness to provide written informed consent and comply with the study protocol.

研究组 & 干预措施

Ozone Disinfection

Experimental

Implant sites assigned to the experimental intervention receive ozone disinfection before dental implant placement.

干预措施: Ozone Implant Site Disinfection (Procedure)

Conventional Disinfection

Experimental

Implant sites assigned to the control intervention receive conventional implant site disinfection before dental implant placement.

干预措施: Conventional Socket Disinfection (Procedure)

结局指标

主要结局

Primary Implant Stability (Insertion Torque)

时间窗: Immediately after implant placement

Primary implant stability will be assessed immediately after implant placement by measuring insertion torque (Ncm).

次要结局

未报告次要终点

研究者

发起方
Zeliha Başak Çakır Erdil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zeliha Başak Çakır Erdil

Research Assistant in Periodontology

Adiyaman University

研究点 (1)

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