Closure of a Guided Immediate Implant Placed in the Extraction Socket With Bone Augmentation in the Lateral Area of the Maxilla or Mandible, With a Temporary Composite Abutment vs With a Custom-made Zirconium Oxide Abutment.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- SIA Adenta
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Stability of crestal bone
研究概览
简要总结
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
- Males and females at least 18 years of age or older.
- One implant per patient.
- Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- Lateral individual teeth (premolars and molars).
- Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- The gingival contour of the tooth to be extracted - without recession.
- Adjacent anterior teeth have no periodontal loss.
- There are no implants in the adjacent teeth.
- Non-traumatic tooth extraction, which results in intact walls of the socket.
Exclusion criteria:
- Deep occlusion (severe, class II).
- The patient smokes a lot (more than 10 cigarettes per day).
- Systemic disease (osteoporosis).
- No initial stability has been achieved after the implant insertion procedure.
详细描述
General Notes
40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group).
Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used.
Allogenic bone botiss maxgraft® cortical granules are used as graft material.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Each patient has their individual ID number
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
- •Males and females at least 18 years of age or older.
- •One implant per patient.
- •Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data.
- •Lateral individual teeth (premolars and molars).
- •Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall).
- •The gingival contour of the tooth to be extracted - without recession.
- •Adjacent anterior teeth have no periodontal loss.
- •There are no implants in the adjacent teeth.
- •Non-traumatic tooth extraction, which results in intact walls of the socket.
排除标准
- •Deep occlusion (severe, class II).
- •The patient smokes a lot (more than 10 cigarettes per day).
- •Systemic disease (osteoporosis).
- •No initial stability has been achieved after the implant insertion procedure
研究组 & 干预措施
Kompozite closure
Immediate implant placement and temporary closure of tapered implants with a custom-made composite shaper after tooth extraction with bone augmentation by using allogeneic bone.
干预措施: Kompozite closure (Procedure)
Individual abutment
Immediate implant placement and temporary closure of tapered implant with a custom-made zirconium oxide abutment after tooth extraction with bone augmentation by using allogeneic bone.
干预措施: Individual abutment (Procedure)
结局指标
主要结局
Stability of crestal bone
时间窗: Before surgery, immediately after surgery, 3 moth, 1 year follow up
To compare crystal bone stability CBCT will be taken before surgery. , immediately after surgery, after 3 month and a follow up after 1 year. The change in the buccal vertical bone level will be measured as the difference between the former and the new vertical distance from implant platform to the buccal alveolar crest. While the change in the buccal horizontal bone dimension will be measured as the difference between the former and the new horizontal distance between the implant and the outer surface of the buccal plate. Both measurements will be taken using CBCT, one immediately after the surgery and the other one 3 month later
The change of position of implant using surgical guide
时间窗: Before surgery and immediately after surgery
To compare implant position accuracy using surgical guide, the following two things will be compared: DICOM after the surgery witch contains information on the implant position in the bone and the STL file witch contains information on implant position before the surgery. There are taken cone beam computer tomography before and immediately after surgery, then 3 month and 1 year follow up.
The changes of stability of soft tissue
时间窗: Before surgery, immediately after surgery, 3 month, 1 year follow up
Recession (REC) state of the gingival/mucosa border - registered by means of a periodontal probe from the incisal edge to the border of the medial, zenith and distal zones. There are taken scans with 3Shape Trios4 before surgery, immediately after, then 3 month and 1 year follow up to compare soft tissue stability
次要结局
未报告次要终点
研究者
Vitālijs Gnusins
Doctor of dental Surgery
SIA Adenta