The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets: A Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- buccal ridge height change in mm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Non-restorable tooth indicated for extraction in esthetic maxillary zone
- •Anterior or premolar teeth
- •Apical chronic pathosis
- •Motivated patients, agree to sign informed consent and complete the follow-up period
- •FMPS of <15% and a FMBS <10%
Exclusion Criteria
- •Pregnant or lactating females
- •Active infection at extraction site
- •Systemic conditions affecting healing (e.g. diabetes, Paget disease or hyperthyroidism, medications as bisphosphonates...)
Arms & Interventions
Alveolar ridge preservation using demineralized dentin combined with I-PRF + 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
Intervention: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (Procedure)
Alveolar ridge preservation using demineralized dentin combined with I-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
Intervention: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF (Procedure)
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
Intervention: Alveolar ridge preservation using autogenous demineralized dentin graft alone (Procedure)
Outcomes
Primary Outcomes
buccal ridge height change in mm
Time Frame: 6 months
Difference in height linear measurements between baseline and final CBCT scans
Secondary Outcomes
- Alveolar ridge bucco-lingual width change in mm(6 months)
- patient discomfort and pain(7 days postoperatively)
- the need for additional augmentation during implant placement(6 months)
- Alveolar ridge bucco-lingual width change in mm(6 months)
- Histomorphometric analysis(6 months)
- palatal ridge height change in mm(6 months)
Investigators
Mohamed Talaat Mohamed Mahmoud El Behwashy
Principal Investigator. Mohamed Elbehwashy
Cairo University