Multiple Implant Placement with Simultaneous Soft Tissue Augmentation Using a Volume-stable Collagen Matrix Compared to Autogenous Connective Tissue Graft: a Clinical, Histological and Volumetric Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- keratinized tissue height
研究概览
简要总结
Background: To our knowledge, no study evaluated the use of VCMX at multiple implant sites and compared its efficacy and safety to a SCTG with the same dimensions. Therefore, we propose in the present protocol to evaluate the efficacy of VMCX to increase the thickness and height of soft tissue when placed at the time of multiple implant placement, as compared to SCTG.
Material and Methods: This study will be conducted in the saint joseph university periodontology department on at least 5 to 10 patients. The studied sites are the edentulous posterior mandible in a split-mouth model. The test groups are the groups grafted with VCMX and the control groups are the groups grafted with SCTG.
Some studies have been reported to compare these two techniques. But the specificity of our study is soft tissue augmentation on multiple implant sites in a split-mouth design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adults ;18 years old.
- •Patients with adequate oral hygiene (FMPI<20% and FMBI<20%).
- •Healed implant sites (tooth extraction at least 8 to 12 weeks before enrolment).
- •Patients who need prosthetic rehabilitation of at least two implants in the left and right posterior mandibular area.
- •Inadequate amount of soft tissue where the implants are planned to be placed: thin mucosal tissues covering the edentulous alveolar ridge.
- •Compliant patients are willing to sign an informed consent.
排除标准
- •Uncontrolled periodontal disease.
- •Heavy smoker (>10 cigarettes per day).
- •General contraindications for dental surgical treatment.
- •Insufficient bone volume for implant placement requiring bone augmentation procedures.
- •History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years.
- •Pregnancy or breastfeeding.
- •Previous and concurrent medication affecting bone and mucosal healing.
- •Disease affecting bone and connective tissue metabolism.
- •Immediate implant placement.
研究组 & 干预措施
Fibrogide group
we are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement
干预措施: dental implant (Procedure)
Fibrogide group
we are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement
干预措施: Fibrogide membrane (Procedure)
Fibrogide group
we are comparing the grafting of fibrogide(VCMX) with the connective tissue graft on multiple implant placement
干预措施: second stage (Procedure)
Connective Tissue graft Group
干预措施: dental implant (Procedure)
Connective Tissue graft Group
干预措施: connective tissue graft (Procedure)
Connective Tissue graft Group
干预措施: second stage (Procedure)
结局指标
主要结局
keratinized tissue height
时间窗: at the day of the surgery and after 3 months
we will calculate the keratinized tissue height before the 1st surgery and before the 2nd stage with a periodontal probe
mucosal thickness
时间窗: at the day of the surgery and after 3 months
when doing the1st surgery(implant placement and soft tissue graft) and at the 2nd stage we will perform a mid crestal incision and reflect only the buccal flap , we will then with a periodontal probe calculate the peri-implant soft tissue thickness of the lingual flap (that we did not reflect). finally we will compare both measurments.
次要结局
- time of the surgery(during the surgery)