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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05470673
• Other study ID #: perio2022ARP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: September 2023

Study information

• Verified date: September 2022
• Source: Cairo University
• Contact: Mohamed Talaat, Master Degree
• Phone: +201009174617
• Email: Mohamed.Talaat[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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...)

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Faculty of dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hämmerle 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. — View Citation

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). pii: 29. doi: 10.3390/dj10020029. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar ridge apico-coronal height change in mm	Difference in height linear measurements between baseline and final CBCT scans	6 months
Secondary	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
Secondary	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