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

The Effect of Autogenous Demineralized Dentin Graft Combined With Injectable PRF Loaded With Metronidazole Versus Autogenous Demineralized Dentin Graft Alone on Alveolar Ridge Preservation of Infected Sockets: A Randomized Controlled Clinical Trial

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 (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: 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

Detailed Description

Many studies have reported an approximately 50% reduction in alveolar bone both the horizontal and vertical directions over 12 months with more than two-thirds of the reduction occurring in the first three months after extraction. 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 '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 bone". 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, 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Procedure: 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 forming sticky demineralized tooth graft with slowly released metronidazole then inserted in the extraction socket and covered then suturing
ACTIVE_COMPARATOR: 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	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 inserted in the extraction socket as particulate demineralized dentin graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar ridge apico-coronal height change in mm	Difference in height linear measurements between baseline and final CBCT scans	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar ridge bucco-lingual width change in mm	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	6 months
Histological assessment	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).	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19.
• Elfana A, El-Kholy S, Saleh HA, Fawzy El-Sayed K. Alveolar ridge preservation using autogenous whole-tooth versus demineralized dentin grafts: A randomized controlled clinical trial. Clin Oral Implants Res. 2021 May;32(5):539-548. doi: 10.1111/clr.13722. Epub 2021 Mar 1.
• van Orten A, Goetz W, Bilhan H. Tooth-Derived Granules in Combination with Platelet-Rich Fibrin ("Sticky Tooth") in Socket Preservation: A Histological Evaluation. Dent J (Basel). 2022 Feb 16;10(2):29. doi: 10.3390/dj10020029.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (ACTUAL): July 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: perio2022ARP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No