跳至主要内容
临床试验/NCT04338139
NCT04338139Unknown不适用

Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration: a Human Study

Saint-Joseph University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1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
30
试验地点
2
主要终点
linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations

研究概览

简要总结

to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study:

  • Pre-operatively:

  • cone beam computed tomography CBCT

  • 1 minute mouthwash with a 0.12% Chlorhexidine solution

  • Full thickness muco-periosteal flap and ridge curettage.

  • Drilling and implant placement (any implant system)

  • Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.

  • Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.

  • Post-operatively:

  • Medication:

  • Amoxicilline (1g) or Clindamycine (300mg)

  • Analgesic, (paracetamol + codeine)

  • Mouthwash with a solution of 0.12% Chlorhexidine

  • cone beam computed tomography CBCT

  • 4 months postoperatively: CBCT

Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years old
  • Smoking <10 cigarettes/day (Light smoker)
  • Good general health.
  • Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.

排除标准

  • A pregnant or nursing mother
  • Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy.
  • Orthodontic treatment in progress or planned
  • Adjacent risk teeth

结局指标

主要结局

linear measurements on the superimposed CBCTs of the buccal bone width gain at different locations

时间窗: 1 year

cbct radiographic measurements

次要结局

  • linear measurements of the amount of grafted bone resorption(1 year)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验