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

Study Overview
=================
Brief Summary
-----------------
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

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

Official Title
-----------------
The Effect of Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial

Conditions
-----------------
Alveolar Bone Loss

Intervention / Treatment
-----------------
* Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graft
* Procedure: Alveolar ridge preservation using particulate deproteinized bovine bone graft


Participation Criteria
=================
Eligibility Criteria
-----------------
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...)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alveolar ridge preservation using autogenous demineralized dentin block graft<br>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<br>* 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<br>|
| Active Comparator: Alveolar ridge preservation using particulate deproteinized bovine bone graft<br>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<br>* Atraumatic extraction of non restorable tooth, then the socket will be packed by particulate deproteinized bovine bone<br>|

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 | 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 | 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). | 6 months |