Clinical and Radiographic Performance of Early Loaded Dental Implants With a Conditioned Hydrophilic Surface: A Prospective Cohort Study With an 8.5- to 9.5-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Clinical performance - implant success
研究概览
简要总结
Objective: To assess the clinical outcomes and patient satisfaction of early loaded implants with a hydrophilic, moderately rough surface for partially edentulous patients after a follow-up of 8.5 to 9.5 years.
Materials and methods: A prospective observational single-centre study involving 15 patients with single, delayed placement and early loaded implants in the posterior area was performed. Clinical and radiographical parameters, including biological and technical complications and patient satisfaction, were assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between the ages of 18 and 75 years (inclusive)
- •Partially edentulous patients with missing teeth in the posterior mandible (positions 34-37 and 44-47) and a healed site at least four weeks after tooth extraction
- •Patients requiring a single dental implant
- •Patients with physical status 1 or 2 according to the American Society of Anesthesiologists Classification System
- •Inadequate native bone quality and quantity to place implants with a diameter of ≥4.0 mm
- •Removable prosthesis or complete dentures in the antagonizing dentition
- •Written informed consent
排除标准
- •Patients with compromised general health contraindicating surgical intervention
- •Presence of conditions requiring chronic routine prophylactic or prolonged use of antibiotics
- •Heavy smokers (exceeding ten cigarettes/day or equivalent) and chewing tobacco users
- •Pregnancy or childbearing potential with a positive urine pregnancy test
- •Insufficient oral hygiene, untreated periodontitis (any residual pockets >4 mm), or persistent intra-oral infection
- •Mucosal diseases such as erosive lichen planus
- •Patients with severe bruxism or clenching habits
- •Unwillingness to participate in the study
结局指标
主要结局
Clinical performance - implant success
时间窗: 10 years
Implant success was classified as the absence of persisting subjective discomfort (patient compliance), lack of recurrent peri-implant infection with suppuration (European Federation of Periodontology 2018), absence of implant mobility on manual palpation, absence of any continuous peri-implant radiolucency at the radiological assessment.
Clinical performance - complications
时间窗: 10 years
A visual exploration of each implant and reconstruction was performed to detect any biological and technical complications.
Clinical performance
时间窗: 10 years
Patient satisfaction with the implant treatment was evaluated using a 10 cm visual analogue scale (VAS). From 0 (The worst) to 10 (The best).
Clinical performance - survival
时间窗: 10 years
Survival was classified as the continued presence of both the implant and reconstruction in the mouth with no need of replacement and/or repair
Clinical performance - peri-implant health
时间窗: 10 years
During the clinical follow-up appointments, peri-implant health was evaluated by using a periodontal probe. Keratinized mucosa (mm) All parameters were evaluated mesially, distally, buccally, and orally in each implant; following the EFP guidelines (European Federation of Periodontology 2018).
Clinical performance - prosthetic success
时间窗: 10 years
Prosthetic success was defined as the absence of technical complications without needing any reconstruction repair.
Clinical performance - PIBL, implant-crown fit
时间窗: 10 years
To assess implant-crown fit (misfit yes/no), a standardized digital periapical radiograph was taken at the scheduled follow-up visits. An independent examiner performed a radiological linear evaluation (mm) using image analysis software (ImageJ)
次要结局
未报告次要终点