Clinical, Radiographic, and Implant Stability Outcomes Following Immediate Implant Placement Using Osseodensification Versus Conventional Drilling in Mandibular Molar Extraction Sockets: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary Implant Stability
研究概览
简要总结
The goal of this randomized clinical trial is to compare osseodensification and conventional drilling for immediate dental implant placement in mandibular molar extraction sockets in adults requiring extraction and implant replacement.
The main questions it aims to answer are:
Does osseodensification improve primary and secondary implant stability compared with conventional drilling? Does osseodensification result in better clinical and radiographic peri-implant outcomes, including marginal bone loss, peri-implant bone density, probing depth, plaque and bleeding indices, during the healing period?
Researchers will compare immediate implant placement performed using osseodensification drilling with immediate implant placement performed using conventional drilling to determine whether osseodensification provides superior implant stability and peri-implant tissue outcomes.
Participants will:
Undergo atraumatic extraction of a mandibular molar followed by immediate implant placement.
Be randomly assigned to receive implant site preparation using either osseodensification or conventional drilling.
Receive the same implant system and standardized surgical and prosthetic protocols.
Attend scheduled follow-up visits for clinical examinations, implant stability measurements using resonance frequency analysis (ISQ), and radiographic evaluation of marginal bone loss and peri-implant bone density during healing and after prosthetic restoration.
详细描述
Immediate implant placement into fresh extraction sockets has become a well-established treatment approach because it reduces treatment time, decreases the number of surgical procedures, and helps preserve hard and soft tissue architecture. Nevertheless, obtaining adequate primary implant stability in fresh mandibular molar extraction sockets remains a major clinical challenge because of socket morphology, limited interradicular bone, and variations in bone density.
Osseodensification is a non-subtractive osteotomy preparation technique that uses specially designed burs rotating in a densifying mode to preserve and compact bone around the implant osteotomy. Unlike conventional drilling, which removes bone during osteotomy preparation, osseodensification compacts autogenous bone along the osteotomy walls, potentially increasing bone density, bone-to-implant contact, and primary implant stability while promoting favorable healing.
Although promising results have been reported for osseodensification, clinical evidence directly comparing this technique with conventional drilling during immediate implant placement in mandibular molar extraction sockets remains limited. This randomized clinical trial was designed to evaluate whether osseodensification provides superior clinical, radiographic, and implant stability outcomes compared with conventional drilling.
Eligible participants requiring extraction of a mandibular molar followed by immediate implant placement were randomly allocated to one of two treatment groups:
Osseodensification group: implant osteotomy prepared using the osseodensification drilling protocol.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 20 years - 50 years. Patients requiring extraction of a mandibular first or second molar with immediate implant placement.
- •Presence of sufficient interradicular and apical bone to achieve primary implant stability following immediate implant placement.
- •Adequate bone dimensions to accommodate the planned dental implant without the need for extensive bone augmentation.
- •Good oral hygiene and willingness to comply with the study protocol and follow-up visits.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Uncontrolled systemic diseases or medical conditions contraindicating oral surgery or implant placement.
- •Pregnancy or lactation. Current smokers or tobacco users. Untreated active periodontal disease or poor oral hygiene. Acute infection or extensive pathology at the implant site that would preclude immediate implant placement.
- •History of radiotherapy to the head and neck region or treatment with intravenous bisphosphonates or other medications known to adversely affect bone healing.
- •Bruxism or parafunctional habits likely to compromise implant success. Inability or unwillingness to attend scheduled follow-up visits or comply with study requirements.
结局指标
主要结局
Primary Implant Stability
时间窗: Day 0, and 3 months
Implant stability, measured by the Implant Stability Quotient (ISQ) using resonance frequency analysis (RFA), assessed immediately after implant placement (primary stability) and during the follow-up period (at 3 months) to evaluate secondary stability. Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell® device. Stability will be expressed as the Implant Stability Quotient (ISQ), a unitless index ranging from 1 to 100, where higher ISQ values indicate greater implant stability. Measurements will be obtained by attaching a SmartPeg to the implant and recording ISQ values in two perpendicular directions (buccolingual and mesiodistal). The mean of the two measurements will be used for statistical analysis. Implant stability will be evaluated immediately after implant placement (baseline/primary stability), and at 3 months and 6 months postoperatively (secondary stability). The primary outcome will be the difference in mean ISQ values between the
次要结局
- Modified Bleeding Index (mBI)(Baseline, 3 months, and 6 months after implant placement)
- Secondary Implant Stability(3 months after implant placement)
- Marginal Bone Loss (MBL)(Baseline, 3 months, and 6 months after implant placement)
- Peri-implant Bone Density(Baseline, 3 months, and 6 months after implant placement)
- Peri-implant Probing Depth (PPD)(3 months and 6 months after implant placement)
- Modified Plaque Index (mPI)(Baseline, 3 months, and 6 months after implant placement)
研究者
Sally Abd-ElMeniem ElHaddad
Assist. Prof. Periodontology and Oral Medicine, College of Dentistry
Dar Al Uloom University