Ridge Preservation Comparing the Clinical and Histologic Healing of Two Different Putty Bone Grafts
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Alveolar ridge height
研究概览
简要总结
The primary aims of this study are to compare, after 4 months, the clinical and histologic results of a combination demineralized/mineralized putty allograft vs. synthetic calcium phosphosilicate (CPS) putty alloplast graft utilization in socket preservation procedures. A regenerative tissue matrix membrane will be used to cover each graft lying below the flap.
详细描述
Study design Thirty patients will be treated using the principles of guided bone regeneration utilizing a full thickness flap for ridge preservation. Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft with a regenerative tissue matrix membrane. The positive control group of fifteen patients will receive an intrasocket synthetic resorbable calcium phosphosilicate putty alloplast graft covered with a regenerative tissue matrix membrane. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
Presurgical Management
Each patient will receive a diagnostic work-up including standardized radiographs (periapical), cone beam computed tomography (CBCT) scan, study casts, clinical photographs, and a clinical examination to record attachment level, probing depth, recession, and mobility of teeth adjacent to the extracted sites. Customized acrylic occlusal stents will be fabricated on the study casts to serve as fixed reference guides for the measurements. Presurgical preparation will include detailed oral hygiene instructions. Baseline data will be collected just before the surgical phase of the treatment. Baseline data will include:
Clinical Measurements
Baseline and 4-month data will include the following:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study involves an investigator (surgeon) and an examiner. The examiner measures the clinical parameters before and after surgery and is blinded to the surgical procedure and type of graft the patient receives.
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
- •Have one non-molar tooth requiring extraction that will be replaced by a dental implant.
- •The site must be bordered by at least one tooth.
- •Healthy male or female who is at least 18 years old.
- •Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
排除标准
- •Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- •Presence or history of osteonecrosis of jaws.
- •Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- •Patients who have been treated with oral bisphosphonates for more than three years.
- •Patients with an allergy to any material or medication used in the study.
- •Patients who need prophylactic antibiotics
- •Previous head and neck radiation therapy.
- •Chemotherapy in the previous 12 months.
- •Patients on long term NSAID or steroid therapy.
- •Pregnant patients.
研究组 & 干预措施
demineralized and mineralized combination putty bone allograft
Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft (MinerOss Putty, BioHorizons) with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons) following tooth extraction.
干预措施: demineralized and mineralized combination putty bone allograft (Biological)
calcium phosphosilicate putty alloplast graft
The positive control group of fifteen patients will receive an intrasocket synthetic resorbable calcium phosphosilicate putty alloplast graft (NovaBone, Osteogenics) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons) following tooth extraction.
干预措施: calcium phosphosilicate putty alloplast graft (Biological)
结局指标
主要结局
Alveolar ridge height
时间窗: 4 months
Alveolar ridge height (measured in mm) after 4 months of healing
Buccal soft tissue thickness
时间窗: 4 months
Buccal soft tissue thickness at crest of alveolar ridge (measured in mm)
Alveolar ridge width
时间窗: 4 months
Alveolar ridge width (measured in mm) after 4 months of healing
次要结局
- Percentage of vital bone present(4 months)
研究者
Himabindu Dukka
Director, Graduate Periodontics
University of Louisville