Osseodensification Versus Conventional Drilling for Implant Site Preparation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Changes in Implant stability quotient (ISQ values) using resonance frequency analysis
研究概览
简要总结
A total of 34 participants, who require replacement of an anterior or posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the control group, the osteotomy site preparation will be prepared by using conventional surgical drills, while the test group site preparation will involve the use of Densah™ Burs (Versah Co., LLC., USA) as per the osseodensification protocol. In addition to evaluating implant stability, the trial will also report on implant and patient outcomes at various time points.
详细描述
Osseodensification technique has demonstrated increased primary stability and increased bone mineral density around the osteotomy site. The implants placed into osseous densification osteotomies have shown significant increase in insertion and removal torque values. This technique also burnishes bone along the inner layer of the osteotomy site and create a condensed layer of autografted bone along the periphery and apex of the implant. This would, in turn, increase the bone-implant contact enhancing the insertion torque values, and thus, primary implant stability. This new technique has not only shown increased primary implant stability when compared with conventional drilling, but also, shown to have similar clinical safety to conventional methods of osteotomy site preparation. Although osseodensification has been reported to enhance the clinical outcomes of implants by increasing primary stability, its long-term effects on implant stability measurements and implant survival rates are still not clear. The purpose of the present randomized controlled trial is to evaluate the stability of implants placed in sites prepared with either conventional drilling or osseodensification and report on implant and patient outcomes at various time points.
Objectives:
The aims of the randomized controlled trial are:
- To evaluate implant stability as measured by implant stability quotient (ISQ).
- To evaluate the clinical, radiographic outcomes and implant survival rates.
- To evaluate the need for additional bone augmentation at the time of implant placement.
- To evaluate changes in peri-implant marginal bone level.
- To evaluate bone quality as estimated by clinicians during osteotomy preparation.
- To evaluate biological and technical complications during the follow-up period.
- To evaluate patient reported outcomes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
- Double-blinded as both the participants and outcome accessors of radiographic outcomes will be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or over.
- •Require replacement of an anterior or posterior single tooth with dental implant.
- •Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
- •Good compliance and commitment to attend follow-up review appointments.
- •Willing to provide informed consent.
排除标准
- •Localized / generalized periodontitis.
- •Bone metabolic disease and/or taking medications that affect bone metabolism.
- •Long term use of non-steroidal anti-inflammatory medications.
- •History of malignancy, radiotherapy or chemotherapy.
- •Pregnant or lactating women.
- •Severe bruxism or parafunctional habits.
- •Participants, who have controlled medical condition or smokers, will not be excluded in this study
结局指标
主要结局
Changes in Implant stability quotient (ISQ values) using resonance frequency analysis
时间窗: Upto 36 months
Resonance frequency analysis (RFA) will be used to determine stability (the level of osseointegration) in dental implants. The stability will be presented as an implant stability quotient (ISQ) value. The measurements will be recorded at time of implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using resonance frequency analysis.
Implant failure rate
时间窗: Upto 36 months
Implant failure rate will be assessed clinically after one year of implant restoration and annually up to three years.
次要结局
- Descriptive evaluation of biological and technical complications associated with dental implant restorations(Upto 36 months)
- Changes in peri-implant marginal bone level (in mm)(Upto 36 months)
- Patient postoperative experience ( visual analogue scale )(Upto 10 days)
研究者
Maanas Shah
Lecturer
Mohammed Bin Rashid University of Medicine and Health Sciences