Comparison of Five Osteotomy Protocols on Implant Stability and Patient Anxiety: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Insertion Torque at Implant Placement
研究概览
简要总结
This clinical trial is studying different methods of preparing bone for dental implants. When a tooth is missing, a small titanium screw called a dental implant can be placed in the jaw to replace it. The stability of the implant during the first weeks after surgery is very important for long-term success.
In this study, 100 patients each received a single dental implant. They were randomly assigned to one of five surgical methods: drilling at 50, 300, or 800 revolutions per minute (rpm), bone densification using special burs, or bone condensation using condenser drills. The goal was to compare how these techniques affect implant stability, measured by insertion torque and resonance frequency analysis, as well as the patient's anxiety before and after surgery.
This research aims to find which technique provides the best balance between bone healing and patient comfort. All participants were healthy adults, and the study was approved by the institutional ethics committee.
详细描述
This prospective randomized controlled clinical trial was conducted at Istanbul Aydın University, Department of Oral and Maxillofacial Surgery, between 2019 and 2023. A total of 100 systemically healthy adults requiring a single dental implant in a healed edentulous ridge were enrolled. Patients were randomly assigned (n = 20 per group) to one of five osteotomy protocols:
Sequential drilling at 50 rpm without irrigation
Sequential drilling at 300 rpm with irrigation
Sequential drilling at 800 rpm with irrigation
Osseodensification with densifying burs at 1200 rpm (counterclockwise, irrigated)
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 (Investigator, Outcomes Assessor)
盲法说明
The surgeon could not be blinded due to the nature of the interventions. However, implant stability was measured by an independent assessor, and statistical analyses were performed by a blinded biostatistician.
入排标准
- 年龄范围
- 20 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 20-78 years
- •Single-tooth healed edentulous ridge
- •First-time implant candidates
- •Preoperative cone-beam computed tomography (CBCT) available
- •American Society of Anesthesiologists (ASA) Physical Status I
- •Non-smokers or light smokers (<10 cigarettes/day)
- •Provided written informed consent
排除标准
- •Previous grafting or sinus augmentation at the implant site, including socket grafting after extraction
- •Systemic contraindications to implant surgery
- •Intraoperative complications or postoperative infections
- •Missing insertion torque (IT) or ISQ data
- •Requirement for a submerged (two-stage) protocol
- •Deviations from the standardized surgical protocol or implant system
研究组 & 干预措施
50 rpm - Ultra-low-speed drilling
Sequential osteotomy drilling at 50 rpm without irrigation, followed by implant placement.
干预措施: Osteotomy technique - 50 Rpm (Procedure)
300 rpm - Moderate-speed drilling
Sequential osteotomy drilling at 300 rpm with external irrigation, followed by implant placement.
干预措施: Osteotomy technique - 300 Rpm (Procedure)
800 Rpm - High-speed drilling
Sequential osteotomy drilling at 800 rpm with external irrigation, followed by implant placement.
干预措施: Osteotomy technique - 800 Rpm (Procedure)
DNS - Osseodensification
Osteotomy prepared with Densah® burs (Versah, USA) at 1200 rpm counterclockwise with irrigation, following pilot drilling.
干预措施: Osteotomy technique - DNS (Osseodensification) (Procedure)
CDS - Bone condensation
Osteotomy prepared with condenser drills (Surgident, South Korea) at 50 rpm clockwise without irrigation, following pilot drilling at 800 rpm.
干预措施: Osteotomy technique - CDS (Bone Condensation) (Procedure)
结局指标
主要结局
Insertion Torque at Implant Placement
时间窗: At the time of implant placement.
Maximum insertion torque (Ncm) recorded at implant placement using a calibrated surgical motor and confirmed with a manual torque wrench when needed.
Implant Stability Quotient (ISQ)
时间窗: At baseline, 1 week, 1 month, 2 months, and 3 months after implant placement.
Implant stability measured by resonance frequency analysis (RFA) using the Osstell Mentor™ device. Mean of buccolingual and mesiodistal measurements recorded.
次要结局
- Change in Patient-Reported Anxiety (VAS)(Preoperative (within 30 minutes before surgery) and immediate postoperative (within 30 minutes after surgery).)
- Procedure-Related Adverse Events(From surgery to 3 months.)
研究者
Sercan Küçükkurt
Associate Professor
Istanbul Aydın University