A Prospective, Randomized, Controlled, Multi-center Evaluation of Extraction Socket Management Comparing Two Socket Sealing Collagen Matrices
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters
研究概览
简要总结
A prospective RCT of intact extractions with delayed implant placement comparing extraction socket management effectiveness and office economics of two collagen matrices. Soft tissue wound healing will be assessed out to 4-months post-operative, when implants will be placed.
详细描述
A prospective, randomized, multi-center, controlled clinical study of intact extractions (bony dehiscences <1/3 socket apico-coronal and mesial-distal dimension) with delayed implant placement. Study objective: to compare extraction socket management effectiveness and office economics of a frequently used wound dressing (control) with a soft tissue augmentation matrix (test) in 32-64 subjects 18 -75 years of age with intact (bony dehiscence, if present, < 1/3 socket dimension) extractions intended for dental implant replacement. Following screening subjects will undergo tooth extraction and randomization to either the control or test therapy. After treatment, subjects will be followed until 4- months, the time of implant placement. Primary outcome: soft tissue wound healing measured by (1) gap closure and (2) graft containment at all time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject indicated for anterior tooth extraction (from premolars forward) intended for implant placement.
- •Subjects with essentially intact extraction sockets - bony dehiscences < 1/3 the depth of socket and mesial-distal width of tooth socket
- •Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
- •Subjects must be able and willing to follow study procedures and instructions
排除标准
- •Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
- •Subjects taking intramuscular or intravenous bisphosphonates.
- •Subjects who have a known allergy or sensitivity to collagen.
- •Subjects with acute, suppurative lesions with pain, swelling and apical lesions > 5mm will be excluded, though antibiotic prophylaxis may be employed to reduce infection and provide possible subject reconsideration for inclusion.
- •Heavy smokers/tobacco users defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day. For non-heavy smokers, smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day is prohibited for the duration of the study.
- •Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
- •Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
- •Subjects, who in the opinion of the Investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
研究组 & 干预措施
Control Collagen Wound Dressing
Bovine collagen sponge used to control bleeding, stabilize blood clots and protect dental wounds
干预措施: Control Collagen Wound Dressing (Device)
Test Collagen Matrix
Bilayer, porcine collagen matrix for soft tissue regeneration used as a socket seal in extraction socket grafting
干预措施: Test Collagen Matrix (Device)
结局指标
主要结局
Socket Soft Tissue Gap Closure - linear measures buccal-lingual in millimeters
时间窗: 4-months
Longitudinal extraction socket soft tissue gap closure measured buccal-lingual from baseline to 4-months.
次要结局
- Socket Soft Tissue Gap Closure - linear measures mesial-distal(4-months)
- Inflammation Score (Loe and Sillness)(4-months)
- Biomaterial Integrity - 4-point scale(4-months)
- Graft Containment as observed by subject and examiner (yes/ no)(4-months)
- Tissue Thickness - probe show-thru at baseline and biopsy measure in millimeters at 4-months(4-months)