Effect of Demineralized Dentin Matrix Versus Mineralized Plasmatic Matrix on Alveolar Ridge Preservation in Molar Extraction Sites; A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Alveolar Ridge Width
研究概览
简要总结
When a tooth is removed, the bone around it (called the alveolar ridge) naturally shrinks. This study compares two bone grafting materials to find out which one better preserves bone after molar extraction:
Demineralized Dentin Matrix (DDM): A material made from the patient's own extracted tooth, treated to remove minerals while keeping bone-forming proteins.
Mineralized Plasmatic Matrix (MPM): A mixture of a standard bone substitute and platelet-rich plasma from the patient's blood.
详细描述
Alveolar ridge resorption is a predictable biological process following tooth extraction, particularly in molar sites where the bone structure is more complex. Maintaining ridge volume is essential for optimal future implant placement and prosthetic rehabilitation. Various grafting materials and biologic enhancers have been used to minimize post-extraction bone loss; however, cost, availability, and biocompatibility remain significant challenges, especially with xenograft and allograft materials.
This randomized clinical trial investigates and compares two autogenous and biologically enhanced approaches for alveolar ridge preservation following molar extraction. The first method utilizes Demineralized Dentin Matrix (DDM) prepared from the patient's own extracted tooth. DDM provides a naturally derived scaffold rich in collagen and bone morphogenetic proteins (BMPs), offering both osteoconductive and osteoinductive potential. The second method uses a Mineralized Plasmatic Matrix (MPM), a combination of a xenograft bone substitute mixed with Platelet-Rich Plasma (PRP), which represents a widely used regenerative option in oral surgery.
The study is designed as a parallel-group, single-blind, randomized clinical trial conducted at the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University. Eligible adult patients requiring extraction of non-restorable multi-rooted molars will be enrolled and allocated equally into two groups. Both groups will undergo atraumatic extraction followed by immediate socket grafting with either DDM+PRF or MPM+PRP.
Standardized postoperative care will be provided to all participants, and healing will be monitored both clinically and radiographically. Cone-beam computed tomography (CBCT) will be used to evaluate alveolar bone width, height, and density immediately after extraction and at 4 months postoperatively. Pain and soft-tissue healing will also be assessed using validated clinical indices.
The study's primary objective is to determine whether Demineralized Dentin Matrix (DDM) provides superior preservation of alveolar ridge dimensions and bone quality compared to Mineralized Plasmatic Matrix (MPM) in molar extraction sites. The hypothesis tested is that there will be no significant difference between both materials regarding bone preservation and regeneration outcomes.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Single-blind design - participants will not be informed which grafting material (DDM or MPM) was used in their treatment. The operating surgeons and data analysts will be aware of the allocation due to the nature of the procedures.
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Non-restorable tooth indicated for extraction Multi-rooted teeth Age group of 18 to 55 years Patients free from any systemic disease that may affect bone healing.
排除标准
- •- Pregnant females Active infection at extraction site Smokers Systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...) Poor oral hygiene. Patient with systemic disease that may affect bone healing. o Uncooperative patient.
研究组 & 干预措施
Demineralized Dentin Matrix (DDM) + Platelet-Rich Fibrin (PRF)
Participants in this group will receive socket grafting using Demineralized Dentin Matrix (DDM) prepared from their own extracted tooth. The dentin is cleaned, ground into particles, demineralized using 0.6 N hydrochloric acid, rinsed with saline, and mixed with autologous Platelet-Rich Fibrin (PRF) before being placed into the extraction socket. The socket is then closed with resorbable sutures for healing.
干预措施: Demineralized Dentin Matrix (DDM) + Platelet-Rich Fibrin (PRF) (Biological)
Mineralized Plasmatic Matrix (MPM)
Participants in this group will receive socket grafting using a Mineralized Plasmatic Matrix (MPM) composed of a commercially available xenograft mixed with Platelet-Rich Plasma (PRP). The mixture forms a cohesive mineralized matrix that is placed into the extraction socket and stabilized with sutures.
干预措施: Mineralized Plasmatic Matrix (MPM) (Biological)
结局指标
主要结局
Change in Alveolar Ridge Width
时间窗: Baseline (immediately postoperative) and 4 months postoperatively.
Measurement of horizontal bone width at the extraction site using cone-beam computed tomography (CBCT).
次要结局
- Change in Alveolar Ridge Height(Baseline (immediately postoperative) and 4 months postoperatively.)
- Change in Bone Density(Baseline (immediately postoperative) and 4 months postoperatively.)
- Postoperative Pain(2 days, 1 week, and 1 month postoperatively.)
研究者
Ahmed Suliman Ahmed Badr
Dr
Cairo University
