Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft for Alveolar Ridge Preservation
Primary Purpose
Alveolar Bone Loss
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Alveolar ridge preservation using autogenous demineralized dentin block graft
Alveolar ridge preservation using particulate deproteinized bovine bone graft
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
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...)
Sites / Locations
- Faculty of dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alveolar ridge preservation using autogenous demineralized dentin block graft
Alveolar ridge preservation using particulate deproteinized bovine bone graft
Arm Description
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
Atraumatic extraction of non-restorable teeth, then the socket will be packed by particulate deproteinized bovine bone graft and covered then suturing
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Alveolar ridge apico-coronal height change in mm
Difference in height linear measurement between baseline and final CBCT scans
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05374083
Brief Title
Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft for Alveolar Ridge Preservation
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alveolar ridge preservation using autogenous demineralized dentin block graft
Arm Type
Experimental
Arm Description
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
Arm Title
Alveolar ridge preservation using particulate deproteinized bovine bone graft
Arm Type
Active Comparator
Arm Description
Atraumatic extraction of non-restorable teeth, then the socket will be packed by particulate deproteinized bovine bone graft and covered then suturing
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge preservation using autogenous demineralized dentin block graft
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge preservation using particulate deproteinized bovine bone graft
Intervention Description
Atraumatic extraction of non restorable tooth, then the socket will be packed by particulate deproteinized bovine bone
Primary Outcome Measure Information:
Title
Alveolar ridge bucco-lingual width change in mm
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alveolar ridge apico-coronal height change in mm
Description
Difference in height linear measurement between baseline and final CBCT scans
Time Frame
6 months
Title
Histological assessment
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Talaat, Master Degree
Phone
+201009174617
Email
Mohamed.Talaat@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of dentistry
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cairo University
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23163915
Citation
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.
Results Reference
background
PubMed Identifier
20461225
Citation
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.
Results Reference
background
PubMed Identifier
25148644
Citation
Pang C, Ding Y, Zhou H, Qin R, Hou R, Zhang G, Hu K. Alveolar ridge preservation with deproteinized bovine bone graft and collagen membrane and delayed implants. J Craniofac Surg. 2014 Sep;25(5):1698-702. doi: 10.1097/SCS.0000000000000887.
Results Reference
background
PubMed Identifier
31781696
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
33982320
Citation
Santos A, Botelho J, Machado V, Borrecho G, Proenca L, Mendes JJ, Mascarenhas P, Alcoforado G. Autogenous Mineralized Dentin versus Xenograft granules in Ridge Preservation for Delayed Implantation in Post-extraction Sites: A Randomized controlled clinical trial with an 18 months follow-up. Clin Oral Implants Res. 2021 Aug;32(8):905-915. doi: 10.1111/clr.13765. Epub 2021 Jun 17.
Results Reference
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Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft for Alveolar Ridge Preservation
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