Autogenous Periosteal Pedicle Graft Versus Pericardium Membrane in Management of Periodontal Intrabony Defects in Stage III Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Clinical Attachment Level (CAL) from Baseline to 6 Months
研究概览
简要总结
The aim of this study is to compare between autogenous PPG and Pericardium membrane in management of periodontal intrabody defects in stage III periodontitis.
详细描述
Periodontitis is a chronic infectious disease that causes damage to periodontal tissues. One of its consequences is alveolar bone resorption, which generates horizontal or vertical bone defects and supra- or intrabony defects, causing mobility and tooth loss.
Periodontal regeneration refers to the restoration of bone, cementum and periodontal ligament to their original levels once damaged by periodontal disease. It has been shown that periodontal regeneration can be achieved by a variety of nonsurgical and surgical procedures.
Surgical modalities of periodontal regeneration include osseous grafts, guided tissue regeneration and a combination of both , Often, a new junctional epithelium is present between the regenerated alveolar bone and the previously diseased root surface.
For intrabony defects regenerative interventions included the use of enamel matrix derivatives, bone grafts, guided tissue regeneration (GTR), and biologic modifiers to achieve regeneration.
GTR is a barrier technique used for the treatment of periodontal bone defects. Guided bone regeneration (GBR) is used to enhance bone growth of the alveolus for implant placement and around peri-implant defects.
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
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients of both sexes aged (25-45) years old.
- •Patients who exhibit signs of (stage III) periodontitis.
- •Healthy individuals and free from systemic disease that may contraindicate periodontal surgery and influence the outcome of the therapy, according to the detailed questionnaire of the dental modification of the Cornell medical index .
- •Patients who have not received antibiotics or any medication for at least 6 months prior to this study.
- •Patients who have not undergone any type of Surgical periodontal therapy 6 months prior to the initial examination.
- •Patients able to return for multiple follow-up visits.
排除标准
- •Pregnant and lactating females .
- •Teeth with mobility greater than Grade I according to Miller classification .
- •Patients with any harmful habits, like smoking or tobacco chewing.
- •Unacceptable oral hygiene after the re-evaluation of phase I therapy.
研究组 & 干预措施
Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft).
● In Group I , OFD will be performed, then a bone graft will be packed into the defect and autogenous PPG will be adapted for defect coverage as an autogenous membrane for GTR.
干预措施: Open Flap Debridement (OFD) (Procedure)
Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft).
● In Group I , OFD will be performed, then a bone graft will be packed into the defect and autogenous PPG will be adapted for defect coverage as an autogenous membrane for GTR.
干预措施: Bone Graft (Procedure)
Group I (Open Flap Debridement (OFD) with autogenous Periosteal Pedicle Graft (PPG) and Bone graft).
● In Group I , OFD will be performed, then a bone graft will be packed into the defect and autogenous PPG will be adapted for defect coverage as an autogenous membrane for GTR.
干预措施: Autogenous Periosteal Pedicle Graft (PPG) (Procedure)
Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft).
● In Group II , OFD will be performed, then a bone graft will be packed into the defect and a pericardium membrane was adapted for defect coverage.
干预措施: Open Flap Debridement (OFD) (Procedure)
Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft).
● In Group II , OFD will be performed, then a bone graft will be packed into the defect and a pericardium membrane was adapted for defect coverage.
干预措施: Bone Graft (Procedure)
Group II (Open Flap Debridement (OFD) with Pericardium membrane and Bone graft).
● In Group II , OFD will be performed, then a bone graft will be packed into the defect and a pericardium membrane was adapted for defect coverage.
干预措施: Pericardium Membrane (Procedure)
结局指标
主要结局
Change in Clinical Attachment Level (CAL) from Baseline to 6 Months
时间窗: Baseline, 3 months, and 6 months
The distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket will be measured in millimeters (mm) using a UNC-15 probe. Improvement in CAL indicates periodontal healing.
次要结局
- Change in Plaque Index (PI) from Baseline to 6 Months(Baseline, 3 months, and 6 months)
- Change in Probing Depth (PD) from Baseline to 6 Months(Baseline, 3 months, and 6 months)
- Change in Gingival Index (GI) from Baseline to 6 Months(Baseline, 3 months, and 6 months)
- Radiographic Bone Fill Measured by Cone Beam Computed Tomography (CBCT) from Baseline to 6 Months(Baseline and 6 months)
研究者
Walaa Ahmed Abd Elaziz Hassanien
Demonstrator
Minia University