Radiographic Evaluation of Crestal Bone Changes Following Equi-crestal Versus Subcrestal Implant Placement in Mandibular Posterior Augmented Ridge. A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Crestal bone changes
研究概览
简要总结
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement
详细描述
Statement of problem: The stability of peri-implant bone is a crucial factor for the long-term success of dental implants, where crestal bone plays a significant role in both the primary as well as the long- term implant stability. A bone loss of 1.5 mm during the first year of loading has been acceptable according to the early standards. However, more bone stability can be expected with the development in implant designs and surfaces over the past decades.
Aim of the study: the aim of this study is to radiographically assess the crestal bone changes following delayed implant placement in mandibular previously augmented posterior sites, comparing cases with equicrestal implant placement with subcrestal implant placement.
Materials and methods
This prospective, parallel, randomized controlled clinical trial will have 36 participants who need implant placement at the posterior mandibular area where they previously received horizontal bone augmentation. They will be randomly allocated into 2 groups, where group A (test) will receive dental implant placed subcrestally and group B (control) will receive implant placed equicrestally. Crestal bone loss will be assessed by periapical radiographs at implant placement (T0), 3 months (T3), 6 months (T6), 12 months (T12) and 18 months (T18) following implant placement. Keratinized tissue width, and soft tissue thickness will be measured clinically by periodontal probe at the same time points. Buccal bone changes will be evaluated at 18 months compared with the preoperative cone beam computed tomography by fusion module. Patient satisfaction will be recorded at the end of the trial.
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
Participants will not know whether the implant is placed crestal or subcrestal Outcome assessor (primary and secondary outcomes) & biostatistician will be blinded.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 21 years.
- •Patients having augmented (by 50/50 particulate xenograft and autogenous bone) edentulous posterior site with vertical bone height of > 10 mm in the mandible with a width of ridge ≥ 7 mm
- •Adequate Inter-arch space for implant placement
- •Favorable occlusion (no traumatic occlusion).
- •Good oral hygiene.•Accepts 18 months follow-up period (cooperative patient)
- •The patient provides informed consent.
排除标准
- •Patients with inadequate bone volume and/ or quality
- •Patients with remaining roots or with signs of acute infection related to the area of interest.
- •Patients having systemic conditions that interfere with normal wound healing
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits .
- •Smoker patients.
- •Pregnant women.
研究组 & 干预措施
Subcrestal implant placement
Delayed implant placement 2 mm subcrestally in missing mandibular posterior site.
干预措施: Subcrestal implant placement (Procedure)
Crestal implant placement
Delayed implant placement equicrestally in missing mandibular posterior site.
干预措施: Crestal implant placement (Procedure)
结局指标
主要结局
Crestal bone changes
时间窗: at baseline,3, 6 ,12 and 18 months
Periapical digital radiographs to determine the amount of crestal bone lose in mm
次要结局
- Keratinized tissue width(at baseline, 3,6,12 and 18 months)
- Patient satisfaction(at baseline, 6 ,12 and 18 months)