Clinical and Radiographic Evaluation of All-on-three Immediately Loaded Mandibular Fixed Detachable Restorations (a Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Radiographic evaluation
研究概览
简要总结
Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.
The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.
详细描述
The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
- •Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
- •Male or female patients aged between 40 and 60 years.
- •Maxillary and mandibular ridges with no history of recent extraction.
- •Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).
排除标准
- •History of radiotherapy in the head and neck region.
- •History of hard tissue augmentation.
- •Presence of any intra-oral pathological condition.
- •Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
- •Smoker and bruxer patients.
研究组 & 干预措施
completely edentulous patients
fixed detachable restorations on three dental implants in the mandible
干预措施: three dental implants (Procedure)
结局指标
主要结局
Radiographic evaluation
时间窗: 12 months
The level of alveolar bone around each implant was evaluated using CBCT. Radiographic assessment of the vertical bone change around each implant was measured and the mean value was calculated. Bone measurements was evaluated at the insertion time then it was evaluated regularly 6 months and 12 months.
Peri-Implant Probing Depth (PIPD)
时间窗: 12 months
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant sulcus depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus with slight pressure. Measurements was made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm was recorded as "2mm" and so forth. The mean records for each implant was then calculated.
Clinical Attachment level (CAL)
时间窗: 12 months
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Implant stability
时间窗: 12 months
Mobility (implant stability) was measured by using RFA (Osstell device instrument). The Osstell unit record numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The larger the ISQ value recorded indicates the more stable the implant-bone interface. Initial stability was checked at the insertion time then it was evaluated regularly, 6 months and 12 months.
次要结局
未报告次要终点
研究者
Naema Ammar
Assistant Lecturer at Removable Prosthodontics Department, Faculty of Dentistry, Pharos University, Alexandria, Egypt
Alexandria University