Comparative Evaluation Of Soft and Hard Tissue Parameters in Immediate Implant Placement using Porcine-Derived Collagen Matrix with Demineralized Freeze-Dried Bone Allograft Vs Enamel Matrix Derivative with Demineralized Freeze-Dried Bone Allograft: A 6-Months Clinico Radiological Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in gingival thickness, keratinized mucosa width, and crestal bone level between Group A (Porcine-derived collagen matrix with DFDBA) and Group B (Enamel matrix derivative with DFDBA) during immediate implant placement.
研究概览
简要总结
This study aims to compare the effectiveness of two different biomaterials: Porcine-Derived Collagen Matrix with Demineralized Freeze-Dried Bone Allograft, and Enamel Matrix Derivative with Demineralized Freeze-Dried Bone Allograft when used in immediate implant placement. A total of 22 patients will be recruited and randomly assigned to two groups. Group A will receive Porcine-Derived Collagen Matrix with DFDBA. Group B will receive Enamel Matrix Derivative with DFDBA. Clinical and radiographic evaluations will be performed to assess changes in gingival thickness, keratinized mucosa width, and crestal bone level at baseline, 4 weeks, 16 weeks, and 6 months. The total study duration is 6 months.
This study is being conducted by Dr Pulkit Kaur Basra, Postgraduate Student, Department of Periodontology, Inderprastha Dental College and Hospital, under the guidance of Dr Preeti Upadhyay, Professor and Head of Department, as part of an MDS dissertation research project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 22.00 Day(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 22 to 70 years, including both male and female participants.
- •Patients having at least one tooth scheduled for extraction due to advanced periodontal destruction, extensive carious lesions, root fracture, or failing endodontic treatment.
- •Patients with no relevant medical history.
- •Patients maintaining good oral hygiene with a plaque index score less than or equal to 1 as per Silness and Loe,
- •Radiographic evidence of adequate buccal and lingual bone measuring at least 1 millimeter.
- •Patients who are willing and able to comply with the treatment protocol.
排除标准
- •Pregnant or lactating women.
- •Radiographic evidence of inadequate buccal bone measuring less than 1 millimeter.
- •Medically compromised patients or those taking immunosuppressive drugs that may complicate the treatment outcome.
- •Patients with systemic diseases that can influence the outcome of treatment.
- •Patients undergoing anticoagulant therapy.
- •Patients with special needs or those who are physically challenged.
- •Patients who use smokeless tobacco or are active smokers.
- •Patients who fail to provide signed informed consent.
- •Patients with a history of allergy to any of the materials used in the study.
- •Patients who are unable or unwilling to maintain proper oral hygiene.
结局指标
主要结局
Change in gingival thickness, keratinized mucosa width, and crestal bone level between Group A (Porcine-derived collagen matrix with DFDBA) and Group B (Enamel matrix derivative with DFDBA) during immediate implant placement.
时间窗: Baseline, 4 weeks, 16 weeks and 6 months
次要结局
- Patient-reported healing and acceptance, ease of handling of biomaterials by operator, and evaluation of long term soft tissue stability.(Baseline, 1 week, 4 weeks, 16 weeks and 6 months.)
研究者
Dr. Preeti Upadhyay
Inderprastha Dental College and Hospital