Sopravvivenza e Healing Rate di Due Tecniche di Otturazione Canalare: Studio Clinico Randomizzato
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Marginal bone level (MBL) around implants
研究概览
简要总结
The purpose of this study is to assess changes in peri-implant tissues and the effectiveness of a tissue-level surgical technique. This technique will be compared with a bone-level surgical technique.
This is a post-marketing clinical investigation conducted in the Endodontics Department of the Dental Clinic at the University of Bologna. Patient recruitment and study conduction will follow the principles of the Declaration of Helsinki and adhere to major international guidelines (CONSORT).
Implants will be placed using either a bone-level or tissue-level surgical technique, corresponding to implants positioned at the level of the gingival mucosa or submerged implants, respectively. Randomization (1:1 ratio) will be conducted before surgery to create two treatment groups. The experimental group (Tissue Level) (n=40) consists of implants that will be placed with the exposed neck (Tissue-level surgical technique). The control group (n=40) comprises implants placed at the bone level (Bone-level surgical technique). The surgeon will be aware of patient assignment during the implant insertion procedures. The surgical procedure to uncover the implant neck (control group) will be performed 3 months after implant placement. The experimental group (Tissue Level technique) will not require a surgical intervention.
he following parameters will be assessed at 1, 6, 12, and 36 months after implant placement: Peri-implant parameters: Plaque score, Bleeding on Probing (BoP), and Papilla Index Radiographic parameters: Marginal Bone Level (MBL) Patient-Reported Outcome Measure (PROM): Post-operative pain (VAS) in the experimental group (non-submerged surgical technique) and the control group (submerged surgical technique).
详细描述
Objectives The purpose of this study is to assess changes in peri-implant tissues and the effectiveness of a tissue-level surgical technique. This technique will be compared with a bone-level surgical technique.
Materials and methods This is a post-marketing clinical investigation conducted in the Endodontics Department of the Dental Clinic at the University of Bologna. Patient recruitment and study conduction will follow the principles of the Declaration of Helsinki and adhere to major international guidelines (CONSORT).
The Endodontics Department has 10 dental units and typically sees 20-30 patients per day. Assuming an average of 1-2 patients per week meeting inclusion criteria, it is anticipated that at least 40 working weeks will be needed to achieve the minimum required sample. The recruitment period is estimated to be around 12-15 months to ensure the recruitment of the required number of patients. Participation in the study will be voluntary, contingent on obtaining written consent.
Implants will be placed using either a bone-level or tissue-level surgical technique, corresponding to implants positioned at the level of the gingival mucosa or submerged implants, respectively. Randomization (1:1 ratio) will be conducted before surgery to create two treatment groups. The experimental group (Tissue Level) (n=40) consists of implants that will be placed with the exposed neck (Tissue-level surgical technique). The control group (n=40) comprises implants placed at the bone level (Bone-level surgical technique). The surgeon will be aware of patient assignment during the implant insertion procedures. The surgical procedure to uncover the implant neck (control group) will be performed 3 months after implant placement. The experimental group (Tissue Level technique) will not require a surgical intervention.
Three months later, the impression will be taken using a digital scanner, and the custom titanium abutment will be secured within 15-21 days. A provisional single acrylic crown will be cemented with temporary cement as a temporary prosthetic rehabilitation. Thirty days later, a definitive prosthetic restoration will be applied using polycarboxylate cement.
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
- Single (Outcomes Assessor)
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
- •Age between 18-75 years;
- •Healthy or with mild functional limitations according to ASA classification 1-2 (16);
- •Consumption of fewer than 10 cigarettes per day;
- •Need for implant rehabilitation in a single-tooth edentulous area;
- •Presence of adequate volumes of bone tissue (3.5mm thickness and 9mm height) to allow proper implant placement and optimal primary stability.
排除标准
- •Age under 18 years;
- •Medical and/or general contraindications to surgical procedures (ASA score ≥3) (16);
- •Poor oral hygiene and lack of motivation and/or active clinical periodontal disease expressed by probing pocket depth >4 mm and bleeding on probing;
- •Smoking more than 10 cigarettes per day;
- •Systemic or local diseases that could compromise post-operative healing and osseointegration;
- •Alcohol and/or drug abuse;
- •Pregnancy or breastfeeding;
- •Malocclusion and other occlusal disorders;
- •Bisphosphonate therapy.
结局指标
主要结局
Marginal bone level (MBL) around implants
时间窗: immediately after implant insertion, 1 month, 3 months, 6 months, 12 months, 24 months and 36 months.
analysis of bone level variations at different time frames
implant survival rate
时间窗: 12 months, 24 months, 36 months from insertion
number of implants still functional at the end of the follow-up
次要结局
- post-operative pain(immediately after insertion, 3months after insertion (crown and abutment applications))
研究者
Fausto Zamparini
Fausto Zamparini
University of Bologna