Comparative Study of Two Different Putty Bone Grafts in Treatment of Intrabony Defects with the Aid of Intramarrow Penetration Technique (Clinical, Radiographical and Histological Evaluation)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical (Clinical attachment level CAL)
研究概览
简要总结
to evaluate and compare efficacy of two different putty forms for both Demineralized Bone Matrix allograft (DBM) and nanocrystalline hydroxyapatite (NCHA) in treatment of intrabony defects with the aid of intramarrow penetration,
A total of twenty patients will be diagnosed with stage III grade B periodontitis according to the Caton classification. They will be selected from the clinic of Department of Periodontology and Oral Medicine, Faculty of Dentistry, Mansoura University
Patients will be classified into two groups:
- Group I: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of nanocrystalline hydroxyapatite in putty form as grafting material.
- Group II: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of Demineralized Bone Matrix allograft putty as grafting material.
Clinical assessment:
including the following parameters:
- Plaque Index (PI).
- Gingival Index (GI).
- Clinical Attachment Level (CAL)
- Probing Depth (PD) Radiological parameters
- The height of the defect: Distance from the CEJ to the alveolar crest (AC)
- Depth of the defect: Distance from CEJ to the base of the defect
- Width of the defect: Highest point of the AC to the root adjacent to the defect
- Defect angle: Two lines that represent the root surface of the involved tooth and the bone defect surface
详细描述
Inclusion criteria:
Both genders with 25-55 years of age. Patients with intrabony defects in the Stage III Grade B periodontitis. Individuals with probing depth ≥ 5mm. Individuals with clinical attachment loss ≥ 5mm. Presence of at least one or more intrabony defect ≥ 3 mm on the radiograpgh patients who had not periodontal therapy in the previous 6 months.
Exclusion criteria:
Patient with stage I, II and IV periodontitis. Pregnant or lactating mothers. Patients having any systemic disease. allergies to Local anesthesia and chlorhexidine, antibiotics, and analgesics will be excluded.
Clinical assessment:
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)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders with 25-55 years of age.
- •Patients with intrabony defects in the Stage III Grade B periodontitis.
- •Individuals with probing depth ≥ 5mm.
- •Individuals with clinical attachment loss ≥ 5mm.
- •Presence of at least one or more intrabony defect ≥ 3 mm on the radiographs.
- •patients who had not periodontal therapy in the previous 6 months.
排除标准
- •Patient with stage I, II and IV periodontitis.
- •Pregnant or lactating mothers.
- •Patients having any systemic disease.
- •allergies to Local anesthesia and chlorhexidine, antibiotics, and analgesics will be excluded.
研究组 & 干预措施
nanocrystalline hydroxyapatite in putty form
• Group I: in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of nanocrystalline hydroxyapatite in putty form as grafting material.
干预措施: nanocrystalline hydroxyapatite in putty form (Procedure)
Demineralized Bone Matrix allograft putty as grafting material
group II in this group, ten patients with intrabony defect will be treated by open flap debridement with decortication followed by placement of Demineralized Bone Matrix allograft putty as grafting material.
干预措施: Demineralized Bone Matrix allograft putty (Procedure)
结局指标
主要结局
Clinical (Clinical attachment level CAL)
时间窗: 3,6,12 months
It was measured since the CEJ to the base of the pocket with UNC-15 periodontal probe
Radiographical Analysis of bone defect
时间窗: at baseline, 6, 12 months
Assessment of bone defect area by digital intraoral periapical (IOPA) radiographs.
次要结局
未报告次要终点
研究者
Afaf Mansour Dao Abdelslam
principle investigator
Mansoura University