Interest of Bone Substitute Material in Immediate Complete Denture: a Controlled Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets
研究概览
简要总结
More than 2 million French people suffer from the widespread disability of edentulism, with large consequences on function, nutrition, aesthetics and well-being. Complete denture is a common therapeutic strategy.
The immediate complete denture technique consists in placing the denture in the same clinical session as last anterior teeth extractions. With this technique, aesthetic and function are immediately reintroduced and the patient is never left toothless or without any denture.
After teeth extractions, alveolar healing process leads to ridge resorption with bone volume modifications and reduction in height and width.
However ridge bone volume is an essential factor in removable denture stability. With implantology as an alternative prosthetic strategy, ridge volume is also a most important factor to place dental implants in a situation close to previous dental roots position. In order to preserve bone volume, a current alternative strategy proposes to place bone substitute materials in tooth sockets after extraction. This strategy was never evaluated with the immediate complete denture technique.
Hypothesis: A new strategy associating immediate complete denture and bone substitute material is more effective than conventional immediate complete denture in a bone preservation perspective.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for maxillary immediate complete denture, presenting a Kennedy
- •Class I partial dentition (bilateral posterior tooth loss)
- •Over 18 years of age
- •Healthy adhering gingiva
- •Willing to participate in the study, able to sign the consent form
排除标准
- •- Medical conditions contraindicating oral surgery: progressive cancer history of radiotherapy in the head and neck region major neurological disease anti-coagulant treatment with prothrombin time<30% valvulopathy, hematologic disease, agranulocytosis, serious heart failure, recent myocardial infarction < 5 years immune deficiency, AIDES osteomalacia hepatic or renal insufficiency unregulated diabetes long-term steroids treatment bisphosphonates
- •Allergy to collagen
- •Pregnant or nursing women
- •Persons specially protected
- •Non-affiliated with the social security system persons
研究组 & 干预措施
Bone substitute material group
Immediate denture placement following extractions and alveolar sockets filling with bone substitute material
干预措施: Bone substitute material group (Device)
Conventional protocol
Immediate denture placement following the conventional protocol
干预措施: Conventional protocol (Device)
结局指标
主要结局
Comparison of bone ridge height one year after maxillary immediate complete denture placement with or without bone substitute material in incisive-canine sockets
时间窗: one year (365 days)
次要结局
- Height and width average between day 10th and day 90th after maxillary immediate complete denture placement, and between day 10th and one year(Day 10, Day 90, Day 365)