Guided Bone Regeneration With and Without Use of Intra-marrow Penetrations: A Prospective Human Clinical and Histologic Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 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 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures.
详细描述
Study Design Twenty-four patients will be treated using the principles of guided bone generation utilizing full thickness flap for ridge augmentation. Twelve test patients will receive guided bone regeneration with intra-marrow penetrations. The positive control group of twelve patients will receive no intra-marrow penetrations. Approximately, six 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. Presurgical preparation will include detailed oral hygiene instructions. Baseline data will be collected just before the surgical phase of the treatment.
Clinical Measurements
Baseline and 6-month data will include the following (for edentulous area or adjacent teeth when necessary):
- Plaque index
- Gingival index
- Gingival margin levels: Measured from cemento-enamel junction (CEJ) to the gingival margin.
- Keratinized tissue: Measured from the gingival margin to the mucogingival junction.
- Clinical attachment level: Measured from CEJ to the bottom of the clinical periodontal pocket.
- Clinical tooth mobility: Measured by using the modified Miller's Index.
- Ridge dimensions: Pre-augmentation and six month healing.
- Soft tissue thickness.
- Radiographic examination including CBCT
- Clinical photographs.
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 if intra-marrow penetrations are utilized.
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
- •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.
结局指标
主要结局
Alveolar Ridge Height
时间窗: 6 Months
Alveolar ridge height (measured in mm) after 6 months of healing
Alveolar Ridge Width
时间窗: 6 Months
Alveolar ridge width (measured in mm) after 6 months of healing
Buccal Soft Tissue Thickness
时间窗: 6 Months
Buccal soft tissue thickness at crest of alveolar ridge (measured in mm)
次要结局
- Histomorphometric Measurements(6 months)
研究者
Himabindu Dukka
Director, Graduate Periodontics
University of Louisville