Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation

Not Applicable

Not yet recruiting

• Conditions: Alveolar Bone Loss
• Interventions: Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft alone; Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole; Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF

• Registration Number: NCT06374784
• Lead Sponsor: Cairo University

Brief Summary

The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth

Detailed Description

Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. During the last decade, efforts have been made to confirm procedures that can prevent bone resorption after extraction. The use of bone grafts aim to promote bone healing and assist bone regeneration. Various types of materials are used for socket preservation, such as autogenous bone, allograft bone, xenograft materials, and alloplast materials.

Dentin contains several growth factors, including transforming growth factor beta (TGF-β), insulin-like growth factor-II (IGF-II) and bone morphogenetic protein-2 (BMP-2), which could be of pivotal importance during any healing event. Demineralization of dentin has been further proposed to expose its collagen matrix, liberate and fossilized; growth factors and thereby enhance its regenerative capacity.

It has been proven that autogenous demineralized dentin graft is effective at reducing dimensional losses of alveolar sockets after 6 months, with no adverse effects.

The efficacy of platelet rich fibrin (PRF) in promoting wound healing and tissue regeneration is at the center of a recent academic debate. The liquid fibrinogen has been shown to bind particulate bone grafts, which are then called sticky bon. This binding improves the stabilization of the particles in the defect. It adds a potential biological effect, which could accelerate the soft tissue healing process and optimize the handling properties of the granules.

The purpose of this clinical trial is to assess the capacity and the clinical feasibility of the dentin graft processed with injectable platelet rich fibrin (I-PRF) to an adherent, tooth-derived conglomerate for socket preservation. Moreover, Platelet-rich fibrin incorporated with antibiotics showed long-term anti-bacterial effect against F. nucleatum and S. aureus.

Both autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) and autogenous demineralized dentin graft (ADDG) alone, loaded with metronidazole or not, with or without collagen membrane, have been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-19
• Study Start: 2024-04-20
• Last Update Submitted: 2024-04-20
• Last Update Posted: 2024-04-23
• Primary Completion: 2024-10-20
• Study Completion: 2024-11-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Non-restorable tooth indicated for extraction
• Single-rooted teeth
• Inactive infection related to the tooth
• Motivated patients, agree to sign informed consent and complete the follow-up period

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Exclusion Criteria

• Pregnant females
• Active infection at extraction site
• Smokers
• Systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alveolar ridge preservation using autogenous demineralized dentin graft alone	Alveolar ridge preservation using autogenous demineralized dentin graft alone	Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and inserted in the extraction socket and covered then suturing
Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole	Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole	Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft and processed with injectable platelet rich fibrin. The injectable PRF will be mixed with 5mg/ml metronidazole first then added to the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing
Alveolar ridge preservation using demineralized dentin combined with I-PRF	Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF	Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using hydrochloric acid (HCL) acid as particulate demineralized dentin graft. The injectable PRF will be mixed with the particulate demineralized dentin graft then inserted in the extraction socket and covered then suturing

Primary Outcome Measures

Name	Time	Method
Alveolar ridge apico-coronal height change in mm	6 months	Difference in height linear measurements between baseline and final CBCT scans

Secondary Outcome Measures

Name	Time	Method
Histological assessment	6 months	Bone samples from control and experimental sites will be taken during implant placement using a trephine bur of a size smaller than the implant. Samples will be examined for new bone formation (Yes/no)
Alveolar ridge bucco-lingual width change in mm	6 months	Alveolar bone linear width will be measured at baseline and after 6 months using cone beam computed tomography (CBCT) scans. The change in bone width will be calculated as the subtraction of final width from baseline width and will be measured in millimetres

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt