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

Cairo University (CU)

Status

Not yet enrolling

Conditions

Alveolar Bone Loss

Treatments

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 alone

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF

Study type

Interventional

Funder types

Other

Identifiers

NCT06374784

perio2023ARP

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Alveolar ridge preservation using demineralized dentin combined with I-PRF + metronidazole

Experimental group

Description:

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

Treatment:

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole

Alveolar ridge preservation using demineralized dentin combined with I-PRF

Experimental group

Description:

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

Treatment:

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF

Alveolar ridge preservation using autogenous demineralized dentin graft alone

Active Comparator group

Description:

Treatment:

Procedure: Alveolar ridge preservation using autogenous demineralized dentin graft alone