Influence of the Design of the Transmucosal Abutment on the Marginal Periimplant Bone Loss. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Radiographic marginal periimplant bone level changes
研究概览
简要总结
The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height
详细描述
Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design.
Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.
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
None of the participants or the outcomes assessor will know the device (transmucosal abutment) received. The care provider will connect the transmucosal abutment while the surgery, after opening the randomization envelope; and the investigator will identify the participant's group while analysing the radiographs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%.
- •Absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit.
- •Adequate bone quality available, allowing placement of MOZO GRAU® implants InHex STD QUATTRO with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
- •Natural teeth or implants with fixed restoration as antagonists.
排除标准
- •Systemic factors:
- •Continuous administration of systemic medication that can interfere with the bone metabolism or medical conditions requiring prolonged use of steroids and / or medications that can interfere with bone metabolism.
- •History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, kidney failure or bone metabolic disorders, such as osteoporosis.
- •Physical disability that may interfere with proper oral hygiene.
- •Use of any investigational medication or device within the previous 30 days to implant surgery in the study.
- •Alcoholism or drug addiction
- •Smoker of more than 10 cigarettes per day.
- •Conditions or circumstances that could prevent compliance with participation in study or interfere with the analysis of results, such as a history of breach or unreliability.
- •Local factors:
- •History of local radiotherapy.
- •Diseases that affect the oral mucosa, such as oral lichen planus.
- •Untreated periodontitis.
- •Persistent intraoral infection.
- •Post-extraction alveoli not cured (less than 6 weeks after extraction).
结局指标
主要结局
Radiographic marginal periimplant bone level changes
时间窗: from baseline (connection of the definitive abutment) to 6 and 12 months after the definitive prostheses will be connected, and finally 3 years later
Measured as the distance from the bone crest to the first implant-to-bone contact. This will be assessed on parallelized periapical radiographies
次要结局
- Bleeding on probing(6 and 12 months after the definitive prostheses will be connected, and finally 3 years later)
- Probing pocket depth(6 and 12 months after the definitive prostheses will be connected, and finally 3 years later)
- Papilla refill(6 and 12 months after the definitive prostheses will be connected, and finally 3 years later)
- Patient Reported Outcomes Measurements(6 and 12 months after the definitive prostheses will be connected, and finally 3 years later)
- Plaque index(6 and 12 months after the definitive prostheses will be connected, and finally 3 years later)
- Adverse effects frequency(6 and 12 months after the definitive prostheses will be connected, and finally 3 years later)
研究者
Juan Blanco Carrión
Professor
University of Santiago de Compostela