Clinical and Radiographic Evaluation of Equicrestal and Subcrestal Positioning of a Tissue Level Implant With Convergent Transmucosal Profile - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Peri-implant mucosa health and condition in terms of Bleeding Index (BI)
研究概览
简要总结
The aim of this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest level).
详细描述
The primary outcomes will be the measurement of the marginal bone level (MBL) at various time intervals and the evaluation of the soft tissues according to a score defined as Pink Esthetic Score (PES). Secondary outcomes will be plaque index (PI); the bleeding index (BI), biological complications (peri-implant mucositis, peri-implantitis, abscesses), implant failure, prosthetic complications (chipping, fractures) and prosthetic failure.
The subjects recruited for the study will be those belonging to the oral surgery department of the San Giovanni di Dio Hospital in Cagliari.
Each patient will receive only one implant or, in any case, only one implant per patient will be included in the analysis. A random sequence will be generated via Randomization.com, useful for assigning patients into the equicrestal and subcrestal implant placement groups.
All patients will undergo the same preoperative, intraoperative and postoperative procedures.
Preoperative procedures An intraoral radiograph of the edentulous site will be performed. Upper and lower alginate impressions will be made on each patient for planning and fabrication of surgical guides, all patients will receive rigorous oral hygiene and instructions will be provided to improve and maintain home oral hygiene.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Absence of periodontal disease
- •Full mouth plaque score and full mouth bleeding score less than or equal to 25%
- •Sufficient bone height and width to place an implant in a prosthetically guided position without performing bone grafting procedures
- •Stable occlusion
排除标准
- •Smokers (more than 10 cigarettes a day)
- •Medical conditions that contraindicate implant surgery
- •Pregnant and breastfeeding patients
- •Patients with a history of therapy with bisphosphonates or biologics
- •Patients undergoing chemotherapy or radiation therapy of the head and neck
- •Decompensated diabetes
- •Severe bruxism
- •Poor oral hygiene or uncooperative patients (incomplete data collection or failure to attend scheduled check-up appointments)
研究组 & 干预措施
Sub-crestal
Implants will be placed 1mm under the bone crest level
干预措施: Sub-crestal Implant placement (Procedure)
Equi-crestal
Implants will be placed at the bone crest level
干预措施: Equi-crestal Implant placement (Procedure)
结局指标
主要结局
Peri-implant mucosa health and condition in terms of Bleeding Index (BI)
时间窗: 6-12 months
The Bleeding Index will be calculated on the sites where the periodontal probing will be carried out, a procedure for measuring the depth of the gingival sulcus on 6 sites per tooth (mesial, central, distal, both vestibular and lingual) with a periodontal probe. A value of 0 will be given if there is no bleeding and 1 if the site bleeds within 30 seconds
Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES).
时间窗: 6-12 months
The PES (Pink Esthetic Score) is a score that evaluates the appearance of the peri-implant soft tissues which examines various parameters giving a value from 0 (worst) to 2 (best) each. (1. the presence/absence of the interproximal papilla both mesial and distal (0=absent, 2=complete); 2. the festooning of the gingival margin in correspondence with the implant (0=unnatural, 2=natural); 3. the position of the gingival margin (0=major discrepancy from reference tooth, 2=no discrepancy); 4. the color of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 5. the appearance (texture) of the soft tissues (0=obvious difference from reference tooth, 2=no difference); 6. defects of the alveolar process (0=obvious deficiency, 2=no deficiency)).
Peri-implant mucosa health and condition in terms of Plaque Index (PI).
时间窗: 6-12 months
The Plaque Index (PI) will be calculated. A value of 0 will be assigned if supragingival plaque is not visible, a value of 1 if visible.
Peri-implant bone health and condition in terms of change in marginal bone level (MBL)
时间窗: 6-12 months
The bone around the implant will be radiographically evaluated in terms of possible resorption measured, using ImageJ software (NIH freeware), on the distal and mesial aspect of each implant at each time point where it is foreseen.
次要结局
未报告次要终点
研究者
Nicola Alberto Valente, DDS, MS, PhD
Assistant Professor
University of Cagliari