Autogenous Demineralized Dentin Block Graft Versus Autogenous Bone Block Graft for Alveolar Ridge Preservation

The Effect of Autogenous Demineralized Dentin Block Graft Versus Autogenous Bone Block Graft on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

The aim of this trial is to compare the effect of autogenous demineralized dentin block graft (ADDBG) versus autogenous bone block graft (ABBG) harvested from maxillary tuberosity on alveolar ridge preservation after extraction of non-restorable single rooted teeth

Study Overview

• Status: Not yet recruiting
• Conditions: Alveolar Bone Loss
• Intervention / Treatment: Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graft; Procedure: Alveolar ridge preservation using autogenous bone block graft

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. A broadly recognized approach is the maintenance of bone walls through bone substitute (graft) delivery into the socket, where guided bone regeneration may be a requisite. Autogenous bone graft has osteogenic and osteoinductive effect. however, when attempts were made to use autologous bone chips in socket preservation, they failed to promote healing or stimulate hard tissue formation in the socket. On the other hand, autogenous bone block graft from the tuberosity has shown a feasible, user-friendly, low-cost solution for minimizing soft and hard tissue collapse and dimensional loss following single-rooted tooth extraction.

Moreover, root dentin block is composed of Type I collagen matrix with several osteoinductive non-collagenous proteins such as bone morphogenetic proteins (BMP) and dentin matrix proteins. Geometrically, alveolar bone morphology was maintained by dentin block graft as well as it has micropores (dentinal tubules) of 3-5 μm diameter and macropores of 0.2-0.3 mm diameter for enhancing osteoinductive and osteoconductive functions.

Both demineralized dentin block and autogenous bone block grafts has 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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-restorable tooth indicated for extraction
• Single-rooted teeth
• 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 Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alveolar ridge preservation using autogenous demineralized dentin block graft; Atraumatic extraction of non-restorable teeth, then the extracted tooth will be prepared and demineralized using HCL acid as demineralized dentin block graft and inserted in the extraction socket	Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graft; Atraumatic extraction of non restorable tooth, then the extracted tooth will be prepared and demineralized by HCL acid and inserted as demineralized dentin block graft in the socket
Active Comparator: Alveolar ridge preservation using autogenous bone block graft; Atraumatic extraction of non-restorable teeth, then autogenous bone block will be harvested from the maxillary tuberosity and reshaped and inserted in the extraction socket	Procedure: Alveolar ridge preservation using autogenous bone block graft; Atraumatic extraction of non restorable tooth, then the autogenous bone block graft will be harvested from the maxillary tuberosity and reshaped and inserted into the socket

What is the study measuring?

Primary 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 (Jung et al., 2013)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alveolar ridge apico-coronal height change in mm	Difference in height linear measurement between baseline and final CBCT scans (Jung et al., 2013) Difference in height linear measurement between baseline and final CBCT scans (Jung et al., 2013) Measures the difference in height linear measurements between baseline and final CBCT scans (Jung et al., 2013)	6 months
Histological assessment	Bone samples from control and intervention 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) and inflammatory response (Yes/no) (Wong and Rabie, 2010).	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.
• Wong RW, Rabie AB. Effect of bio-oss collagen and collagen matrix on bone formation. Open Biomed Eng J. 2010 Mar 9;4:71-6. doi: 10.2174/1874120701004010071.
• Barootchi S, Wang HL, Ravida A, Ben Amor F, Riccitiello F, Rengo C, Paz A, Laino L, Marenzi G, Gasparro R, Sammartino G. Ridge preservation techniques to avoid invasive bone reconstruction: A systematic review and meta-analysis: Naples Consensus Report Working Group C. Int J Oral Implantol (Berl). 2019;12(4):399-416.
• Younes R, Khairallah CM. The "One Piece" Autologous Tuberosity Graft: A Contemporary Concept in Ridge Preservation. Case Rep Dent. 2020 Feb 13;2020:3945076. doi: 10.1155/2020/3945076. eCollection 2020.
• Kim, Y., Fajardo, K., Valera, A. and Um, I. (2017) 'Autogenous Tooth Bone Graft Block For Socket Preservation: A One-Stage Technique', Dentistry, 7(414), pp. 2161-1122.1000414.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 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
• Other Study ID Numbers: perio2022april

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