A Prospective, Multi-centre Study Evaluating Creos™ Xenogain Bone Graft Substitute in Horizontal Ridge Augmentation in the Premolar and Molar Region of the Mandible
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 12
- 主要终点
- Bone gain 8 months after bone augmentation procedure for implant placement.
研究概览
简要总结
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute. Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
详细描述
This clinical investigation is a prospective, multi-centre study to evaluate bone gain after horizontal augmentation using creos xenogain bone graft substitute.
Patients included in the study are in need of a GBR procedure prior to implant placement in the premolar and posterior region of the mandible.
Primary endpoint include the bone gain after 8 months healing period, while secondary endpoints includes histological analysis 8 months after performance of the augmentation procedure as well as Implant survival, implant success and marginal bone levels evaluated over a period of 1 year after definitive prosthetic delivery.
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
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between 18 and 80 years old.
- •Patient has signed informed consent to participate in the study.
- •Patients in need of horizontal ridge augmentation prior to implant placement in the premolar and posterior region of the mandible
- •Horizontal defect classified as: Horizontal medium defect (Hm) (4-6 mm defect) or Horizontal large defect (Hl) (≥7 mm defect)
- •Patients presented with a combination defect Horizontal/Vertical with a maximum of 2mm loss of vertical dimensions (minimal vertical dimension for patient inclusion is 7.5 mm defined as the distance from the anatomical landmark, alveolar nerve or lingual dehiscence)
- •The subject must be in good physical and mental condition
- •The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- •Full-mouth bleeding score (FMBS) lower than 25%.
- •Full-mouth plaque score (FMPI) lower than 25%.
- •The subject is suitable for a 2-stage surgical procedure
排除标准
- •Severe bone defect classified as: Vertical medium (Vm) (4-6 mm defect) or Vertical large, (Vl) (≥7 mm)
- •Medium (Cm) and Large (Cl) classified combination defects Prior bone augmentation in the area planned for treatment (i.e ridge preservation)
- •Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure.
- •Any disorders directly in the planned implant area such as previous tumors, chronic bone disease.
- •Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
- •Alcohol or drug abuse as noted in subject records or in subject history.
- •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 history.
- •Heavy smoking (> 10 cigarettes per day).
- •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%.
- •Poor compliance.
- •Active periodontal disease involving the residual dentition.
- •Mucosal diseases in the areas to be treated.
- •Pregnant or lactating women at the time of bone augmentation procedure.
结局指标
主要结局
Bone gain 8 months after bone augmentation procedure for implant placement.
时间窗: 8 months
To evaluate bone gain 8 months after bone augmentation procedure for implant placement.
次要结局
- Implant survival(6 months and 1 year after definitive prosthetic delivery)
- Implant success(6 months and 1 year after definitive prosthetic delivery)
- Marginal bone levels(6 months and 1 year after definitive prosthetic delivery)
- oral health related quality of life assessment(1 year)
- Histological analysis prior to implant insertion including percentage of vital bone, residual graft and connective tissue or other non bone components(8 months)
- Soft tissue outcome 1 year after definitive prosthetic delivery(1 year)