Alveolar Bone LossNCT05374083
Autogenous Demineralized Dentin Block Graft Versus Particulate Deproteinized Bovine Bone Graft for Alveolar Ridge Preservation
A study testing Alveolar ridge preservation using autogenous demineralized dentin block graft and Alveolar ridge preservation using particulate deproteinized bovine bone graft in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Alveolar ridge preservation using autogenous demineralized dentin block graft and Alveolar ridge preservation using particulate deproteinized bovine bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-restorable tooth indicated for extraction
- Single-rooted teeth
- Motivated patients, agree to sign informed consent and complete the follow-up period
Who cannot join
- Pregnant females
- active infection at extraction site
- Smokers
- systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Alveolar Bone Loss
- Being tested
- Alveolar ridge preservation using autogenous demineralized dentin block graft, Alveolar ridge preservation using particulate deproteinized bovine bone graft
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservation using autogenous demineralized dentin block graftProcedure or surgery
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 graftProcedure or surgery
Atraumatic extraction of non restorable tooth, then the socket will be packed by particulate deproteinized bovine bone
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservation using autogenous demineralized dentin block graft | Experimental | 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 Receives: Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graft |
| Alveolar ridge preservation using particulate deproteinized bovine bone graft | Active comparator | Atraumatic extraction of non-restorable teeth, then the socket will be packed by particulate deproteinized bovine bone graft and covered then suturing Receives: Procedure: Alveolar ridge preservation using particulate deproteinized bovine bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (2)
Alveolar ridge apico-coronal height change in mm
Difference in height linear measurement between baseline and final CBCT scans
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study startJul 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Talaat Mohamed Mahmoud El Behwashy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374083
- Sponsor's protocol ID
- perio2022may
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23163915Wong 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.
PubMed 20461225Pang 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.
PubMed 25148644Barootchi 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.
PubMed 31781696Kim, 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.
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.
PubMed 33982320
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05374083
- Acronym / sponsor ID
- perio2022may
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservation using autogenous demineralized dentin block graft | Experimental | Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graftAtraumatic 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 |
| Alveolar ridge preservation using particulate deproteinized bovine bone graft | Active comparator | Procedure: Alveolar ridge preservation using particulate deproteinized bovine bone graftAtraumatic extraction of non-restorable teeth, then the socket will be packed by particulate deproteinized bovine bone graft and covered then suturing |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-restorable tooth indicated for extraction
- Single-rooted teeth
- Motivated patients, agree to sign informed consent and complete the follow-up period
Key exclusion criteria (4 listed)
- Pregnant females
- active infection at extraction site
- Smokers
- systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar ridge preservation using autogenous demineralized dentin block graftAtraumatic 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 | Procedure or surgery | Alveolar ridge preservation using autogenous demineralized dentin block graft |
| Alveolar ridge preservation using particulate deproteinized bovine bone graftAtraumatic extraction of non restorable tooth, then the socket will be packed by particulate deproteinized bovine bone | Procedure or surgery | Alveolar ridge preservation using particulate deproteinized bovine bone graft |
Primary outcome
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
2 secondary outcomes
Alveolar ridge apico-coronal height change in mm
Time frame: 6 months
Histological assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 23163915Jung 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.
- Background: PubMed 20461225Wong 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.
- Background: PubMed 25148644Pang 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.
- Background: PubMed 31781696Barootchi 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.
- BackgroundKim, 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.
- Background: PubMed 33982320Santos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation using autogenous demineralized dentin block graft and Alveolar ridge preservation using particulate deproteinized bovine bone graft in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Talaat, Master Degree (+201009174617, Mohamed.Talaat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar ridge bucco-lingual width change in mm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374083, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.