Clinical and Radiographic Evaluation of Immediate Versus Delayed Loading of Dental Implants at the Anterior Maxilla
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Implant Stability (ISQ)
研究概览
简要总结
This interventional comparative clinical study was conducted to evaluate and compare the clinical stability and radiographic outcomes of immediate versus delayed loading of dental implants placed in the anterior region of the maxilla. Immediate loading protocols have been shown to improve oral health-related quality of life and patient satisfaction; however, their influence on implant stability and osseointegration remains an area of ongoing investigation.
A total of sixteen dental implants were placed and the participants were randomly allocated into two equal groups using a computer-generated randomization method (www.Randomizer.org). In Group I (control group), eight implants were placed and restored following a delayed loading protocol, with prosthetic loading performed six months after implant placement. In Group II (study group), eight implants were placed and immediately loaded with provisional polymethyl methacrylate (PMMA) restorations. After six months, the provisional restorations were replaced with definitive fixed prostheses.
Preoperative planning of implant placement was performed using cone beam computed tomography (CBCT). Clinical evaluation of implant stability was carried out using the Osstell device, while radiographic assessment of peri-implant bone density and marginal bone changes was performed using standardized indirect digital radiographs. Radiographic evaluations were obtained immediately after implant placement and at six months postoperatively. The clinical and radiographic outcomes of both loading protocols were compared to assess implant stability and 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
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 20-55 years
- •Both genders
- •Healthy individuals (ASA I) without systemic diseases
- •Patients with one or more missing teeth in the anterior maxilla
排除标准
- •Pregnant or lactating women, or females with osteoporosis
- •Patients with harmful oral habits such as bruxism or smoking
- •Poor oral hygiene
- •Gingival or periodontal diseases with severe vertical or horizontal bone loss
- •Teeth with periapical or lateral infections or lesions
研究组 & 干预措施
Delayed Loading Group
Participants in this group received a single dental implant placed in the anterior maxilla. A total of eight implants were placed and restored using a delayed loading protocol, with prosthetic loading performed six months after implant placement.
干预措施: Dental Implant (Device)
Immediate Loading Group
Participants in this group received a single dental implant placed in the anterior maxilla. A total of eight implants were placed and immediately loaded with provisional restorations. After six months, the provisional restorations were replaced with definitive fixed restorations.
干预措施: Dental Implant (Device)
结局指标
主要结局
Implant Stability (ISQ)
时间窗: Baseline (immediately after implant placement) and 6 months postoperatively
Clinical stability of dental implants was assessed using the Osstell device. The implant stability quotient (ISQ) was measured immediately after implant placement and at 6 months postoperatively. ISQ scores range from 1-100, with scores ≥70 indicating high stability, 60-69 medium stability, and \<60 low stability.
Peri-implant Bone Density
时间窗: Baseline, 3 months, 6 months
Bone density around the implants was measured using standardized direct paralleling digital periapical radiographs and analyzed with IDRISI Kilimanjaro software. Two zones were evaluated: the osseointegration zone near the implant border and the surrounding bone interface. Measurements were recorded immediately postoperatively and at 3 and 6 months.
次要结局
- Postoperative Pain (Visual Analog Scale, VAS)(1, 3, and 7 days postoperatively)
- Visual Scale of Edema(1, 3, and 7 days postoperatively)