A Comparative Study of Osseodensification Burs Versus Osteotome Preparation on the Stability of Implants Placed in Low Bone Density Areas: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Secondary Implant Stability using radio frequency analysis (RFA)
研究概览
简要总结
The objective of this study is to compare the primary stability of implant sites prepared using conventional drilling, osseodensification (Densah bur), and osteotome preparation techniques, and to evaluate the influence of these methods on implant success rates in areas of low bone density.
详细描述
in different conditions implants that lack primary stability is subjected to excessive micromotion that can lead to implant failure. This usually happens when dental implants pass the critical limit of micro-motion. Passing this critical limit can interfere with Osseo-integration and cause fibrous encapsulation of dental implant .
Implant Failure usually occurs in completely edentulous maxillae especially in the posterior area where bone quality is compromised.
Clinicians usually refer implants success rates to the difference in bone quality between mandible and maxilla. Higher failure rates seem to be associated with poor bone quality.
Primary stability is affected by several factors including Bone Quantity and quality, the Implant macro- and micro- design, and the used osteotomy technique.
Osteotomies are usually created using conventional drills, although the implant diameter must be slightly larger than the final drill to ensure primary stability However, this conventional drilling technique might be insufficient to provide the primary stability required for Osseo-integration in areas of low bone quality. Several site preparation techniques have been introduced to enhance primary stability in soft bone. Some clinicians used under-sized drilling however the efficiency of this technique is conditioned by decreasing osteotomy diameter by 10% of implant diameter.
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
Blinding was maintained throughout the clinical trial for all data collection and outcome assessments. Insertion torque and Implant Stability Quotient (ISQ) values were recorded immediately, 3 months post-surgery, and 6 months post-loading by two independent examiners who were not involved in the surgical procedures and were blinded to patient allocation. Additionally, radiographic outcomes-specifically marginal bone loss evaluated on CBCT images-were assessed by an independent professional who was strictly
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low bone density (D3), (D4) Missing maxillary posterior teeth
- •edentulous ridge should be 8 mm or more of bone height and bone width ≥ 7mm with adequate inter-occlusal space of at least 8mm,
- •Patients with good oral hygiene or willing to improve their oral hygiene.
排除标准
- •Patients with uncontrolled medical conditions that affect Osseo-integration.
- •Patients receiving medications that contraindicate osteotomy.
- •Heavy smokers.
- •History of receiving irradiation in the head and neck region.
研究组 & 干预措施
Conventional Drilling
Implant sites in this arm will undergo osteotomy preparation using standard conventional drilling sequences according to the implant manufacturer's recommendations prior to implant placement
干预措施: Conventional Osteotomy (Procedure)
Densah Bur (Osseodensification)
Implant sites in this arm will undergo osteotomy preparation using the osseodensification technique with Densah burs (Versah) running in a counter-clockwise direction (densifying mode) prior to implant placement.
干预措施: Densah Bur drilling (Procedure)
osteotome
Implant sites in this arm will undergo osteotomy preparation using summers osteotome technique for lateral bone condensation and expansion prior to implant placement
干预措施: osteotome bone condensation (Procedure)
结局指标
主要结局
Secondary Implant Stability using radio frequency analysis (RFA)
时间窗: readings were taken 3 months post operative and 6 months after loading.
Implant stability measured using Resonance Frequency Analysis (RFA) via Osstell. Values recorded as ISQ (1-100) to evaluate osseointegration. where higher scores indicates higher stability
primary stability using Insertion Torque Value.
时间窗: day of surgery
Evaluation of implant stability was done by measuring Insertion torque. Using the surgical contra-angled hand piece the initial torque value was set to10Ncm then increased sequentially by 5Ncm according to the torque required to place the implant at the desired depth. The final torque value used to drive the implant to its position was recorded as the peak insertion torque
Primary Implant Stability measured through Resonance Frequency Analysis (RFA)
时间窗: the day of surgery
Implant stability will be measured using Resonance Frequency Analysis (RFA) via an Osstell device. The values are recorded as Implant Stability Quotient (ISQ) on a scale from 1 to 100, where higher scores indicate greater stability
次要结局
- Secondary Implant Stability using radio frequency analysis (RFA)(readings were taken 3 months post operative and 6 months after loading.)
- Marginal Bone Loss (MBL)(cbct was done at implant placement and 3 months post operative and 6 months after loading.)
研究者
Mohamed Mahmoud
Principal Investigator
Future University in Egypt