Evaluation of Clinical and Radiographic Parameters in Bony Defects Treated With Recombinant Human Platelet-derived Growth Factor in Combination With Allograft
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Gingival Recession
研究概览
简要总结
Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor.
The objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft.
Our hypothesis: Defects treated with DFDBA and rhPDGF-BB have better clinically and radiographic results that the defects treated with DFDBA and saline solution.
详细描述
The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.
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, Care Provider, Outcomes Assessor)
盲法说明
It is a triple-blind study, where the operator, the investigator and the statistician have no knowledge of the material placed in the procedure.
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
- •Clinical diagnosis of periodontitis
- •Infrabony defects of 2 walls, 3 walls and combined defects
- •Patients ASA (American Society of Anesthesiologists) I and II
- •Patients who smoke less than 10 cigarettes
排除标准
- •Patients undergoing bisphosphonate therapy
- •Furcation defects
- •Patients with evidence of blood dyscrasias.
- •Pregnant patient
结局指标
主要结局
Gingival Recession
时间窗: Initial and six months after surgery
The distance from the soft tissue (gingiva or alveolar mucosa) margin to cemento-enamel junction, ≥1 millimeters (mm)
Radiographic Measurements
时间窗: Initial and six months after surgery
Cemento-enamel junction (CEJ)-Defect Base (DB): The distance of the cementoenamel junction at the base of the defect. Cemento-enamel junction (CEJ)-Bone crest (BC): The distance of the cemento-enamel junction to the crest of bone. Cemento-enamel junction (CEJ)- Root apex (RA): The distance of the cemento-enamel junction to root apex. Lineal Bone Growth (LBG) = CEJ to base of defect at baseline - CEJ to base of defect at 6 months. %BF: Percent bone fill was calculated by dividing LBG by the depth of the original bone defect
Bleeding on probing
时间窗: Initial and six months after surgery
Method to asses gingival inflammation. Gingival health is defined as \< 10% bleeding sites
Clinical Attachment Level
时间窗: Initial and six months after surgery
The distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing, ≥2 mm (millimeters)
Gingival Phenotype
时间窗: Initial and six months after surgery
Gingival phenotype is determined by gingival thickness and keratinized tissue width. Probe visible: thin (≤1 mm). Probe not visible: thick (\>1mm).
Probing depth
时间窗: Initial and six months after surgery
The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm)
Plaque control record
时间窗: Initial and six months after surgery
O'Leary index is used for assessing oral hygiene skills of the patient
次要结局
未报告次要终点
研究者
Jesus Israel Rodríguez Pulido
Doctor
Universidad Autonoma de Nuevo Leon