Early Stability of Short Dental Implants With Shallow Threads in the Posterior Mandible: A Controlled Clinical Pilot Study .
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Implant Stability Quotient (ISQ) at Baseline (T0)
研究概览
简要总结
Early Stability of Short vs. Standard Dental Implants in the Posterior Mandible
This study compares how well short dental implants (7mm) work compared to standard-length implants (11mm) when placed in the back part of the lower jaw. Both types of implants have special shallow threads designed to reduce stress on the bone. The main goal is to see how stable they are during the first 4 weeks after placement-a critical time for healing.
- Short implants may be a good option for patients with limited jawbone height, avoiding the need for bone grafting.
- Understanding their early stability helps dentists decide when it's safe to place teeth on them.
- This study uses advanced tools like 3D scans (CBCT) and implant stability measurements (ISQ) to track healing.
What will happen in the study?
- Screening: A dental exam and 3D scan to check bone quality.
- Implant Placement:
- Short (7mm) or standard (11mm) implant, depending on your bone height.
- Minimally invasive surgery with local anesthesia.
- Follow-ups: Painless stability checks at end of 1, 2, 3, and 4 weeks using a small device (RFA).
Who can participate?
Adults (18-60 years) missing posterior teeth in the lower jaw, with:
- Enough bone width (≥6.5mm).
- No uncontrolled health conditions (e.g., severe diabetes).
- Non-smokers or light smokers (<10 cigarettes/day).
- Benefits: Free implant placement and monitoring; contributes to better dental care.
- Risks: Typical surgery risks (swelling, infection); rare nerve injury (<5% chance).
How long is the study?
- Active participation: 4 weeks (with optional long-term follow-up).
- Total study duration: ~12 months (including data analysis). Mohammad Abdulwahab Al-Jonaid University of Science and Technology, Sana'a.
- Supervisor: Dr. Ali Al-Hudaied, Oral and Maxillofacial Surgery Specialist.
详细描述
A prospective, controlled, parallel-group pilot clinical trial comparing 7mm short implants (SHI) versus 11mm standard implants (SDI) with identical shallow-thread macrodesign (depth <0.5mm) and 4.2mm diameter. Implant allocation is anatomically driven based on CBCT-measured vertical bone height (7mm group: 8.5-9mm residual bone; 11mm group: ≥12.5mm).
Technical Innovations
- Thread Geometry: Dual shallow-thread reverse-buttress design (0.2-0.5mm depth) with progressive pitch to optimize cortical engagement while minimizing shear stress (Ao et al. 2010).
- Surgical Protocol: Standardized osteotomy using under-drilling for D2 bone (final drill diameter reduced by 0.2mm) and non-condensing drilling for D3 bone to prevent over-compression.
- Stability Metrics:
- Primary Stability: ITV (last quarter-turn torque) + ISQ (Penguin RFA, mean of 4-directional measurements).
- Dynamic Stability: ISQ tracked at T0 (baseline), T1 (7d), T2 (14d), T3 (21d), T4 (28d) to capture dip magnitude (ΔISQ) and recovery onset (start of biological stability).
Bone Density Integration
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
This clinical trial employs partial masking (blinding) to minimize bias in outcome assessments:
- Blinded Parties
- Outcome Assessors:
- The researcher performing resonance frequency analysis (RFA) measurements (ISQ values at T0-T4) is masked to:
- Implant length (7mm vs. 11mm)
- Insertion torque value (ITV) Rationale: Prevents measurement bias in stability tracking.
- Data Analysts:
- Statisticians processing ISQ trends are blinded to group allocation until analysis completion.
- Non-Blinded Parties
- Surgeon: Cannot be masked due to visual/tactile differences during osteotomy preparation.
- Patients: Aware of implant type due to post-operative healing abutment visibility.
- Blinding Methods
- RFA Protocol:
- SmartPeg placement/readings performed by a separate researcher not involved in surgery.
- ISQ values recorded using coded forms without implant length details.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Adults ≥18 years with partial posterior mandibular edentulism.
- •Bone height ≥7 mm and width >6 mm (CBCT-confirmed).
- •D2/D3 bone density (HU: 350-1250).
- •Healed posterior mandibular sites (3-6 months post-extraction).
- •Good oral hygiene (plaque index ≤1).
- •Willingness to adhere to study protocols.
排除标准
- •1. Uncontrolled systemic diseases (e.g., diabetes with HbA1c >7%, liver disease) or medications affecting bone healing (e.g., corticosteroids, bisphosphonates).
- •2. History of head/neck radiotherapy (with in past year).
- •Heavy smoking (>10 cigarettes/day).
- •Absolute contraindications for oral surgery (e.g., recent MI/CVA < 6months, bleeding disorders).
- •5. Active periodontal disease, parafunctional habits as bruxism, or prior bone grafting at the site.
结局指标
主要结局
Implant Stability Quotient (ISQ) at Baseline (T0)
时间窗: Measurement at implant placement(Day 0)
Mean Resonance frequency Analysis(RFA) measurement taken immediately post-implantation(T0), to assess primary mechanical stability. ISQ range 1-100, low stability \<60, medium stability 60 to 69, high more than or equal 70. Reported as mean ISQ value per group.
Insertion Torque value- ITV.
时间窗: Measurement at during implant placement (intraoperative)
The rotational torque in Ncm,applied during the final quarter-turn of implant insertion. This is direct measure of primary mechanical stability. Reported as mean ITV per group.
Magnitude of Stability Dip
时间窗: from implant placement (Day 0) through week4
The mean lowest point of stability curve , calculated as the greatest negative change in ISQ value from the baseline T0, measurement for each implant during the 4 -week monitoring period.
Time of Onset of Secondary Stability
时间窗: from Day0 , through week 4.
The mean time in days post implantation at which the ISQ value begins to consistently increase, indicating the start biological secondary stability. Defined as the time point after the nadir -T2or T3.where the ISQ value shows a positive increase confirmed at the subsequent measurement.
次要结局
未报告次要终点
研究者
Mohammad A Al-Jonaid M.Sc.
M.Sc Candidate in Oral Surgery and implantology
University of Science and Technology, Yemen