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临床试验/CTRI/2026/01/100174
CTRI/2026/01/100174尚未招募3 期

Comparative Evaluation Of Efficacy Of Demineralised Bone Matrix With Resorbable Collagen Membrane And Platelet Rich Fibrin After Extraction Of Mandibular Molar For Socket Preservation.

nair hopsital dental college1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月12日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Compare and Evaluate of Efficacy of Demineralised Bone

研究概览

简要总结

This study includes patients (18–60 years) undergoing mandibular molar extraction at the Oral and Maxillofacial Surgery Department. After obtaining informed consent and basic blood investigations (CBC), patients will be randomly assigned to two groups:

  • Group A: Socket preservation using Demineralised Dentin Matrix (Osseograft) with a Resorbable Collagen Membrane.
  • Group B: Socket preservation using Platelet-Rich Fibrin (PRF) prepared from autologous blood by centrifugation at 3000 rpm for 10 minutes.

Each group will be further divided into subgroups based on age (18–39 and 40–60). All extractions will be performed under local anesthesia using standard aseptic protocols by a single operator. After placement of materials, resorbable sutures will be placed.

Patients will receive standard post-extraction medications (Amoxicillin 500 mg and Diclopara TDS for 5 days). CBCT scans will be taken before extraction and at 4 months post-operatively. Healing will be evaluated at 7 days and 4 months post-op.

Parameters assessed include:

  • Alveolar bone height and width (using CBCT measurements),
  • Bone density via gray scale values (DICOM viewer),
  • Clinical healing (pain, swelling, infection),
  • Comparison of socket healing between materials.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Day(s) 至 60.00 Day(s)(—)
性别
All

入选标准

  • Individual Falling In 18-39 years And 40-60 years Age Groups 2) Individual In Need of Mandibular Molar Extraction.
  • Healthy Individual Without Any Co- Morbidity.

排除标准

  • Individuals With Known H/O Of Thyroid Disorder, Renal Disease, Diabetes Mellitus, Uncontrolled Hypertension, Under Antiplatelets & Anticoagulant Therapy, Bronchial Asthma.
  • Pregnant Females.

结局指标

主要结局

Compare and Evaluate of Efficacy of Demineralised Bone

时间窗: 4 months

Matrix with Resorbable Collagen Membrane and Platelet Rich

时间窗: 4 months

Fibrin for Preservation of Alveolar Socket after Extracti on of

时间窗: 4 months

Mandibular Molars.

时间窗: 4 months

次要结局

未报告次要终点

研究者

发起方
nair hopsital dental college
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

kshitija dhoke

Nair hospital dental college

研究点 (1)

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