NCT02898311Unknown不适用
One-Tooth One-Time (1T1T) A Straightforward Approach to Replace Missing Teeth in the Posterior Region: a Case Series
适应症
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- Prosthesis complication rate
研究概览
简要总结
This study evaluates the success rate, as the biological and prosthesis complications, of posterior single-unit implants immediately loaded with a chair side Computer-Aided Design and Manufacturing (CAD-CAM) composite crown, after a follow-up period of 6 months,1,2,3,4 and 5 years.
Complementary ex vivo analyses will be performed to evaluate the wear of restorations. The time and cost benefit of the presented digital workflow, as patient centered outcomes will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
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
- •0 In good systemic health (ASA I/ II)
- •Present with no contra indication against oral surgical interventions
- •The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
- •At least 8 mm of bone in the vertical dimension
- •At least 6 mm of bone in the bucco-lingual dimension.
- •No need for bone augmentation procedure in any of the dimensions
- •Full mouth plaque score (FMPI) lower or equal than 25%
排除标准
- •Autoimmune disease requiring medical treatment
- •Medical conditions requiring prolonged use of steroids
- •Use of Bisphosphonate intravenously or more then ˃ 3 years of oral use
- •Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- •Current pregnancy or breastfeeding women
- •Alcoholism or chronically drug abuse
- •Immunocompromised patients
- •Uncontrolled Diabetes
- •Prisoners
- •Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
- •Local exclusion criteria:
- •Sites treated with socket preservation techniques
- •Untreated local inflammation
- •Mucosal diseases or oral lesions
- •History of local irradiation therapy in Head-Neck area
- •Persistent intraoral infection (periodontitis, caries, …)
- •Patients inadequate oral hygiene or unmotivated for normal home care.
- •Removable prosthesis as an antagonist of the teeth to be replaced or absence of antagonistic teeth
- •Severe bruxism or parafunctions
结局指标
主要结局
Prosthesis complication rate
时间窗: 6 months
Implant complication rate
时间窗: 6 months
次要结局
- Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire(6 months)
- Evaluation of treatment duration, timing (in minutes) all the different steps of the surgical and prosthodontic procedure.(1 day)
- Evaluation of patient satisfaction with VAS (visual analog scale) questionnaire(1 day)
研究者
Mainjot Amélie
Associate professor- Head of Clinic
University of Liege
研究点 (2)
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