Evaluation of Non-Incised Papillae Surgical Approach (NIPSA) Versus Conventional Flap in Periodontal Reconstructive Surgery of Intrabony Defects (Clinical and Radiographic Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gingival Recession
研究概览
简要总结
Objectives: To compare the effectiveness of Non-Incised Papillae Surgical Approach (NIPSA) versus conventional flap with mineralized Freeze-Dried Bone Allograft (FDBA) in periodontal reconstructive surgery of intrabony defects (Clinical and Radiographic study).
Patients and methods: Twenty patients with stage III/IV periodontitis with vertical intraosseous defect treated with NIPSA plus FDBA (n=10) or Conventional flap plus FDBA (n=10) were analysed. All patients met the same inclusion criteria and were treated following the same protocol, except for the surgical management of soft tissue (NIPSA versus Conventional flap). Clinical parameters were assessed at baseline, three months and sixmonths. Radiographic parameters were assessed at baseline and six months.
详细描述
IPatients' selection: Twenty patients with periodontitis were diagnosed with vertical intra-osseous periodontal defects. They were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University putting into consideration certain inclusion and exclusion criteria. The patients have known all of the needed information about the treatment protocols and the materials they would receive. All possible risks and other treatment options had been reviewed and explained to the patients. The patients were cooperative and they understood this explanation. Written consent had been taken from each patient before performing any steps and approved from the ethical committee of our college
Inclusion criteria:
- Patients with stage III/IV periodontitis.
- Age Group between 30 to 50 years old.
- Active residual pockets (positive bleeding on probing) associated with intrabony defects.
- Periodontal lesions with probing depth (PD) ≥ 5 mm and extension of the intrabony defect ≥ 3 mm.
- Vertical intrabony periodontal defects, always involving the buccal aspect.
Exclusion criteria:
- Systemic disease contraindicating periodontal surgery.
- Smokers.
- Diabetic patients.
- Pregnant patients.
- Third molars or teeth with incorrect endodontic or restorative treatment.
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 (Participant)
盲法说明
The patients were randomly selected into either study group (NIPSA) or control group (Conventional falp) using the coin toss method. Hence the study groups were classified into two groups as follows, group I (study group): ten patients treated with NIPSA plus FDBA and group II (Control group): ten patients treated with conventional flap design plus FDBA.
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage III/IV periodontitis.
- •Age Group between 30 to 50 years old.
- •Active residual pockets (positive bleeding on probing) associated with intrabony defects.
- •Periodontal lesions with probing depth (PD) ≥ 5 mm and extension of the intrabony defect ≥ 3 mm.
- •Vertical intrabony periodontal defects, always involving the buccal aspect.
排除标准
- •Systemic disease contraindicating periodontal surgery.
- •Diabetic patients.
- •Pregnant patients.
- •Third molars or teeth with incorrect endodontic or restorative treatment.
结局指标
主要结局
Gingival Recession
时间窗: Three and six months
次要结局
- Location of the tip of the papilla(Three and six months)
- Width of keratenized tissue(Three and six months)
- Probing depth reduction(Three and six months)
- Clinical attachment gain(Three and six months)
- Plaque index(Three and six months)
- Gingival bleeding index(Three and six months)
- Bone gain(Six months)
研究者
Bassant Hamdy Mowafey
Associate professor of Oral Diagnosis and Radiology
Mansoura University