Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Change in Vertical Marginal Bone Loss (VMBL)
研究概览
简要总结
This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.
详细描述
Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.
Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.
Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patient will not know the type of connection of his or her implant until the study has finished. Outcome Assessor will be blinded. In the radiographic evaluation the implant-abutment connection will be hidden to assess the marginal bone loss.
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
- •Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
- •≥18-years-old patients.
- •Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
- •Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
- •O'Leary plaque index and or bleeding on probing ≤25%.
- •Dental implants with screwed-retained prosthesis.
排除标准
- •Systemic diseases that can interfere dental implant placement.
- •Any contraindication for surgery procedures.
- •Heavy smokers (> 20cig/day).
- •Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
- •Patients who have had participated with another clinical trial the last 30 days.
- •Pregnant women or in lactation.
- •Patients with bad oral hygiene or not motivated.
- •Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
- •Guided bone regeneration required in the same time of the implant placement.
研究组 & 干预措施
Ocean E.C.®, Avinent Implant System S.L.
Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and external hexagon connection.
干预措施: Dental Implant Placement (Other)
Ocean I.C.®, Avinent Implant System S.L.
Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and internal hexagon connection.
干预措施: Dental Implant Placement (Other)
Ocean C.C.®, Avinent Implant System S.L.
Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and conical connection.
干预措施: Dental Implant Placement (Other)
结局指标
主要结局
Change in Vertical Marginal Bone Loss (VMBL)
时间窗: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.
次要结局
- Early implant failure(Since implant placement (Timing 0) through prosthesis placement (Timing 1).)
- Late implant failure(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Vertical Marginal Bone Loss Tax(12 months after prosthesis placement.)
- Prosthetic complications(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Bacterial leakage(12 months after prosthesis placement.)
- Probing pocket depth(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Mucosal recession(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Mucosal hyperplasia(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- Clinical attachment level(Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.)
- O'Leary plaque index(First visit)
- Bleeding on probing(Since first visit through study completion (Timing 5), an average of 1 year.)
- Suppuration on probing(Since first visit through study completion (Timing 5), an average of 1 year.)
研究者
Octavi Camps-Font
Professor
University of Barcelona