Regenerative Therapy for Vertical Defects Comparing Demineralized Freeze Dried Bone Allograft (DFDBA) and Regenafil
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- RTI Surgical
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in Probing Depth
研究概览
简要总结
The purpose of this research study was to determine whether treatment with the bone grafting material Regenafil was as effective as the standard treatment using demineralized freeze dried bone allograft (DFDBA). Regenafil is demineralized freeze dried bone in a special gel form.
详细描述
To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in a biologic thermoplastic carrier (Regenafil) to the standard of care. To compare the regenerative effects of a demineralized freeze dried bone allograft (DFDBA) particulate in the treatment of intraosseous vertical defects following six months of healing. This was accomplished by evaluating clinical parameters including probing depth, attachment level and bleeding upon probing, using attachment level as the primary outcome variable.
Treatment of the vertical osseous defect is a challenging problem in periodontics. There are many treatment options including:
- open flap debridement;
- osseous graft alone;
- membrane alone;
- or membrane plus an osseous graft.
Choice of treatment may depend on the defect depth and configuration. A shallow, narrow 3 wall defect may respond well to open flap debridement while a deep 2 wall defect may need regenerative therapy such as an osseous graft, a membrane or combined membrane and graft treatment. Studies of vertical defect therapy with defects about 4 mm or greater show that similar percent defect fill results are obtained with regenerative therapies. Open flap debridement produces substantially less percent defect fill.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Provide written informed consent prior to their participation.
- •Be an adult age 18 and older.
- •Have at least a 4 mm open vertical osseous defect depth on one tooth, visible on a radiograph and with a probing depth ≥ 5 mm.
- •Have osseous defects that are either wide 3-wall, or combination defects.
排除标准
- •Have debilitating systemic diseases, or diseases that affect the periodontium.
- •Have a known allergy to any of the materials that will be used in the study:
- •non-steroidal anti-inflammatory drugs (NSAIDs)
- •chlorhexidine digluconate
- •doxycycline
- •Need prophylactic antibiotics.
- •Have a vertical osseous defect that is related to a furcation area.
- •Smoke more than 1 pack per day.
- •Have endodontically treated teeth or endodontic lesions at study sites.
- •Have 1-wall defects.
- •Have poor oral hygiene.
- •Have anterior fillings (Note: if a subject presents with anterior fillings, it will be at the discretion of the principal investigator as to whether they should be accepted into the study.)
- •Be pregnant as evidenced by a positive urine pregnancy test taken at both the screening and baseline visits.
结局指标
主要结局
Change in Probing Depth
时间窗: baseline and then at 6 months
This is the distance, measured in millimeters (mm) from the gingival margin to the maximal penetration of the probe tip. The measures were made at baseline and then at 6 months after treatment.
Clinical Attachment Level
时间窗: 6 months
The amount of space between attached periodontal tissues and a fixed point, usually the cementoenamel junction. A measurement used to assess the stability of attachment as part of a periodontal maintenance program.
Recession
时间窗: 6 months
CEJ to gingival margin (GM). GM coronal to the CEJ were scored as a negative number.
次要结局
- Gingival Index(6 months)
- Plaque Index(6 months)
- Bleeding on Probing(6 months)
- Mobility Index(6 months)