A Comparative Study to Evaluate Implant Stability and Peri-Implant Marginal Bone Loss Around Two Different Thread and Body Designs of Implants at Specified Time Intervals - An In Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Implant Stability Quotient (ISQ)
研究概览
简要总结
This clinical study was conducted to evaluate the effect of different dental implant designs on implant stability and peri-implant bone levels during the early healing phase. Dental implants are widely used for the replacement of missing teeth, and their long-term success depends on achieving adequate primary stability and maintaining the surrounding bone. Variations in implant design, including thread configuration and body geometry, may influence the mechanical and biological behavior of implants, thereby affecting treatment outcomes.
The purpose of this study was to compare two different implant designs: double-threaded straight-body implants and triple-threaded conical-body implants. A total of 30 patients requiring implant-supported restorations in the posterior mandibular region were included in the study. Participants were randomly allocated into two groups, with each group receiving one type of implant design.
Implant stability was assessed using resonance frequency analysis (RFA), which provides implant stability quotient (ISQ) values as an objective measure of stability. In addition, peri-implant marginal bone levels were evaluated using standardized intraoral radiographs. These measurements were recorded at three time points: at the time of implant placement (baseline), at 3 months, and at 6 months after placement.
The primary objective of the study was to determine whether implant design influences implant stability over time. The secondary objective was to evaluate and compare marginal bone loss around the implants between the two groups during the early healing period.
The main research question addressed in this study was: Does the difference in implant thread design and body geometry significantly affect implant stability and peri-implant marginal bone loss during the early healing phase?
It was hypothesized that implants with a conical body design and multiple thread configuration may provide higher stability due to improved bone engagement and load distribution, while maintaining comparable bone levels around the implant.
The findings of this study are expected to provide clinically relevant evidence regarding the influence of implant macro-design on treatment outcomes. This may assist dental practitioners in selecting appropriate implant systems to enhance primary stability, promote successful osseointegration, and improve long-term prognosis in implant therapy.
详细描述
Dental implants have become a widely accepted and predictable treatment modality for the rehabilitation of partially and completely edentulous patients. The long-term success of dental implants is primarily dependent on achieving and maintaining adequate implant stability and preserving peri-implant bone levels. Implant stability is influenced by several factors, including bone quality, surgical technique, and implant design. Among these, implant macro-design-particularly thread configuration and body geometry-plays a critical role in determining primary stability and stress distribution at the bone-implant interface.
Implant designs vary in terms of thread pitch, depth, and number of threads, as well as body shape (straight/cylindrical versus tapered/conical). Conical implants are believed to enhance primary stability by generating compressive forces within the surrounding bone, especially in areas of low bone density. Similarly, multiple-thread configurations may increase bone-to-implant contact and improve insertion efficiency and mechanical engagement. However, the combined influence of thread design and implant body geometry on implant stability and peri-implant bone behavior remains an area requiring further clinical investigation.
The present study was designed as a randomized, prospective interventional clinical trial with a parallel-group design to evaluate and compare implant stability and peri-implant marginal bone loss between two implant systems with different macro-design characteristics. A total of 30 patients requiring implant-supported restoration in the posterior mandibular region were included. Participants were randomly assigned into two groups using a computer-generated randomization method to ensure unbiased allocation.
Group A received double-threaded straight-body implants, while group B received triple-threaded conical-body implants. All implant placements were performed under standardized clinical conditions using a two-stage surgical protocol. Preoperative clinical and radiographic assessments were carried out to determine bone quality, quantity, and suitability for implant placement. Implant dimensions (diameter and length) were selected based on available bone at the implant site.
Primary implant stability was measured immediately after implant placement using resonance frequency analysis, which provides implant stability quotient values as an objective and non-invasive measure of stability. The same measurements were repeated at 3 months and 6 months postoperatively to evaluate changes in stability over time, reflecting the transition from primary mechanical stability to secondary biological stability during osseointegration.
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
- Single (Outcomes Assessor)
盲法说明
In this study, the examiner responsible for radiographic measurements and statistical analysis was blinded to the group allocation to minimize measurement and assessment bias. Due to the nature of the surgical procedure and differences in implant design, blinding of participants and care providers was not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and above
- •Patients with missing mandibular premolars or molars requiring implant-supported restoration
- •Presence of adequate bone volume and density at the implant site for proper implant placement
- •Patients with good general health and no systemic conditions affecting healing
- •Patients maintaining satisfactory oral hygiene
- •Patients who are cooperative and able to understand the treatment procedure
- •Patients willing to undergo implant surgery and attend follow-up visits
- •Patients who provide written informed consent
排除标准
- •Patients with active infection or pathology at the implant site
- •Patients with insufficient bone quality or volume for implant placement
- •Patients with systemic diseases or conditions that may impair healing
- •Patients with a history of bleeding disorders or on anticoagulant therapy
- •Immunocompromised or medically compromised patients
- •Patients with poor oral hygiene or non-compliance
- •Pregnant or lactating women
- •Patients unwilling to participate or unable to provide informed consent
研究组 & 干预措施
Double-threaded straight-body implant group
Participants in this arm received double-threaded, straight-body dental implants placed using a standardized two-stage surgical protocol. Implant stability (ISQ) and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months to evaluate clinical performance during the early healing phase.
干预措施: Double-threaded straight-body dental implant (Device)
Triple-threaded conical-body implant group
Participants in this arm received triple-threaded, conical-body dental implants. Implant placement was carried out following the same standardized two-stage surgical protocol. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months.
干预措施: Triple-threaded conical-body dental implant (Device)
结局指标
主要结局
Implant Stability Quotient (ISQ)
时间窗: Baseline (immediately after implant placement), 3 months, and 6 months
Implant stability measured using Resonance Frequency Analysis (RFA) and expressed as Implant Stability Quotient (ISQ) values to evaluate primary and secondary stability of dental implants.
Implant Stability Quotient
时间窗: Baseline (immediately after implant placement), 3 months, and 6 months
Implant stability was measured using resonance frequency analysis and expressed as implant stability quotient values to evaluate the primary and secondary stability of dental implants.
次要结局
- Peri-implant marginal bone height(Baseline, 3 months, and 6 months)
- Marginal bone loss(3 months and 6 months)
研究者
Shyamolima Hazarika
DOCTOR
Career Postgraduate Institute of Dental Science and Hospital Lucknow