NCT04383834Unknown不适用
2017-1538: A 3-years Investigator Initiated Study to Evaluate the Soft Tissue Health and Stability in the Mandible and/or Maxilla Using the NobelActive® TiUltra™ and On1™ Base/Xeal™
Giacomo Fabbri1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™
研究概览
简要总结
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •.The subject inclusion criteria are listed below. The subject is at least 18 years of age (or age of consent) and has passed cessation of growth.
- •Obtained informed consent from the subject. The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- •The subject shall be healthy and compliant with good oral hygiene. Full-mouth bleeding score (FMBS) lower than 25 %[10]. Full-mouth plaque score (FMPI) lower than 20% [11]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla.
- •The subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction).
- •The implant sites are free from infection and extraction remnants. The subject is suitable for a 1-stage surgical procedure. Sufficient amount of buccal and lingual keratinized mucosa. The healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems.
- •The subject has a sufficient amount of bone for placing NobelActive TiUltra with a length of at least 7 mm.
- •The following subject inclusion criteria apply at time of surgery:
- •Primary implant stability as assessed by manual hand testing.
排除标准
- •The subject is not able to give her/his informed consent of participating. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- •Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history.
- •Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area.
- •Infections in the planned implantation site or adjacent tissue. Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- •Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.).
- •Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%.
- •Alcohol or drug abuse as noted in subject records or in subject history. Smoking less 10 cigarettes/day. Fresh extraction sites (up to 6 weeks). Severe bruxism or other destructive habits. Pregnant or lactating women at the time of implant insertion. Previous bone augmentation (lateral and/or vertical). Soft tissue augmentation less than 2 months before implant placement. Subject has allergic or adverse reactions to the restorative material
结局指标
主要结局
A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™
时间窗: 47 months (8 months enrolment + 36 months follow up + 3 months study closure)
Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes
次要结局
未报告次要终点
研究者
Giacomo Fabbri
Giacomo Fabbri
Studio Ban Mancini Fabbri
研究点 (1)
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