Demineralized Dentin Matrix Versus Mineralized Plasmatic Matrix on Alveolar Ridge Preservation in Molar Extraction Sites

NCT ID: NCT07239193

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-11-01

Brief Summary

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.

Detailed Description

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.

This trial is expected to provide evidence supporting the clinical viability of using recycled autogenous tooth material as a cost-effective and biocompatible alternative to commercially available xenografts, potentially expanding regenerative options for clinicians and improving access to affordable biologic grafting solutions.

Conditions

Socket Preservation; Alveolar Ridge Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Demineralized Dentin Matrix (DDM) + Platelet-Rich Fibrin (PRF)

Intervention Type: BIOLOGICAL

Autogenous dentin-derived grafting material is used as a bone substitute for alveolar ridge preservation following molar extraction. PRF, obtained from the patient's centrifuged blood, is mixed with DDM to enhance graft stability and promote healing.

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.

Group Type: ACTIVE_COMPARATOR

Mineralized Plasmatic Matrix (MPM)

Intervention Type: BIOLOGICAL

A xenogenic bone substitute is mixed with autologous platelet-rich plasma to form a mineralized plasmatic matrix, which serves as a control graft for ridge preservation after molar extraction.

Interventions

Demineralized Dentin Matrix (DDM) + Platelet-Rich Fibrin (PRF)

Autogenous dentin-derived grafting material is used as a bone substitute for alveolar ridge preservation following molar extraction. PRF, obtained from the patient's centrifuged blood, is mixed with DDM to enhance graft stability and promote healing.

Intervention Type: BIOLOGICAL

Mineralized Plasmatic Matrix (MPM)

A xenogenic bone substitute is mixed with autologous platelet-rich plasma to form a mineralized plasmatic matrix, which serves as a control graft for ridge preservation after molar extraction.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Suliman Ahmed Badr

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Ibrahim ElGhareeb, Phd

Role: STUDY_CHAIR

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University

Salah Eldin ElAbbasy, Phd

Role: STUDY_DIRECTOR

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University

Ahmed Suliman Ahmed, Bds

Role: PRINCIPAL_INVESTIGATOR

Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University

Locations

Faculty of Dentistry, Cairo University - Department of Oral and Maxillofacial Surgery

Cairo, , Egypt

Countries

Egypt

Facility Contacts

Faculty of Dentistry, Cairo University.

Role: primary

dentmail@dentistry.cu.edu.eg

23634965

Other Identifiers

DDM in socket preservation

Identifier Type: -

Identifier Source: org_study_id