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

Alveolar Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05374083
• Other study ID #: perio2022may
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: August 2023

Study information

• Verified date: May 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 block graft (ADDBG) versus particulate deproteinized bovine bone graft (PDBBG) on alveolar ridge preservation after extraction of non-restorable 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: August 2023
• Est. primary completion date: February 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

• 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 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
• 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

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 (6)

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. — 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

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.

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. — View Citation

Santos A, Botelho J, Machado V, Borrecho G, Proença 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. — View 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. — View Citation

Outcome

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