Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft for Alveolar Ridge Preservation

May 11, 2022 updated by: Mohamed Talaat Mohamed Mahmoud El Behwashy, Cairo University

The Effect of Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone 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 particulate deproteinized bovine bone graft (PDBBG) on alveolar ridge preservation after extraction of non-restorable single rooted teeth

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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. The deproteinized bovine bone has been tested in vitro and in vivo in the alveolar ridge preservation and plays a positive role in osteoconductive function. Guided bone regeneration (GBR) procedure has been developed to counteract alveolar ridge bone resorption. GBR technology with xenografts, such as the deproteinized bovine bone mineral, could lead to bone regeneration.

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 particulate deproteinized bovine bone grafts 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)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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 hydrochloric acid (HCL) acid as demineralized dentin block graft and inserted in the extraction socket and covered then suturing
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 hydrochloric acid (HCL) acid and inserted as demineralized dentin block graft in the socket
Active Comparator: Alveolar ridge preservation using particulate deproteinized bovine bone graft
Atraumatic extraction of non-restorable teeth, then the socket will be packed by particulate deproteinized bovine bone graft and covered then suturing
Procedure: Alveolar ridge preservation using particulate deproteinized bovine bone graft
Atraumatic extraction of non restorable tooth, then the socket will be packed by particulate deproteinized bovine bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar ridge bucco-lingual width change in mm
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar ridge apico-coronal height change in mm
Time Frame: 6 months
Difference in height linear measurement between baseline and final CBCT scans
6 months
Histological assessment
Time Frame: 6 months
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

May 7, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • perio2022may

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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