Alveolar Bone LossNCT05347017
Autogenous Demineralized Dentin Block Graft Versus Autogenous Bone Block Graft for Alveolar Ridge Preservation
A study testing Alveolar ridge preservation using autogenous demineralized dentin block graft and Alveolar ridge preservation using autogenous bone block 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 autogenous bone block graft (ABBG) harvested from maxillary tuberosity 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 autogenous bone block graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2022to Jul 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 Autogenous Bone Block 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 autogenous bone block graft (ABBG) harvested from maxillary tuberosity 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. A broadly recognized approach is the maintenance of bone walls through bone substitute (graft) delivery into the socket, where guided bone regeneration may be a requisite. Autogenous bone graft has osteogenic and osteoinductive effect. however, when attempts were made to use autologous bone chips in socket preservation, they failed to promote healing or stimulate hard tissue formation in the socket. On the other hand, autogenous bone block graft from the tuberosity has shown a feasible, user-friendly, low-cost solution for minimizing soft and hard tissue collapse and dimensional loss following single-rooted tooth extraction.
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 autogenous bone block grafts has 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 autogenous bone block 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 HCL acid and inserted as demineralized dentin block graft in the socket
Alveolar ridge preservation using autogenous bone block graftProcedure or surgery
Atraumatic extraction of non restorable tooth, then the autogenous bone block graft will be harvested from the maxillary tuberosity and reshaped and inserted into the socket
| 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 HCL acid as demineralized dentin block graft and inserted in the extraction socket Receives: Procedure: Alveolar ridge preservation using autogenous demineralized dentin block graft |
| Alveolar ridge preservation using autogenous bone block graft | Active comparator | Atraumatic extraction of non-restorable teeth, then autogenous bone block will be harvested from the maxillary tuberosity and reshaped and inserted in the extraction socket Receives: Procedure: Alveolar ridge preservation using autogenous bone block 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 (Jung et al., 2013)
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 (Jung et al., 2013)
Difference in height linear measurement between baseline and final CBCT scans (Jung et al., 2013)
Measures the difference in height linear measurements between baseline and final CBCT scans (Jung et al., 2013)
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) and inflammatory response (Yes/no) (Wong and Rabie, 2010).
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 posted26 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 20 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
- NCT05347017
- Sponsor's protocol ID
- perio2022april
- Status last verified
- Apr 2022
- First submitted
- 20 Apr 2022
- Last updated
- 2 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 20461225Barootchi 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 31781696Younes R, Khairallah CM. The "One Piece" Autologous Tuberosity Graft: A Contemporary Concept in Ridge Preservation. Case Rep Dent. 2020 Feb 13;2020:3945076. doi: 10.1155/2020/3945076. eCollection 2020.
PubMed 32099685Kim, 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 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 Autogenous Bone Block Graft on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05347017
- Acronym / sponsor ID
- perio2022april
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 26 Apr 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 autogenous bone block graft (ABBG) harvested from maxillary tuberosity 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. A broadly recognized approach is the maintenance of bone walls through bone substitute (graft) delivery into the socket, where guided bone regeneration may be a requisite. Autogenous bone graft has osteogenic and osteoinductive effect. however, when attempts were made to use autologous bone chips in socket preservation, they failed to promote healing or stimulate hard tissue formation in the socket. On the other hand, autogenous bone block graft from the tuberosity has shown a feasible, user-friendly, low-cost solution for minimizing soft and hard tissue collapse and dimensional loss following single-rooted tooth extraction.
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 autogenous bone block grafts has 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 HCL acid as demineralized dentin block graft and inserted in the extraction socket |
| Alveolar ridge preservation using autogenous bone block graft | Active comparator | Procedure: Alveolar ridge preservation using autogenous bone block graftAtraumatic extraction of non-restorable teeth, then autogenous bone block will be harvested from the maxillary tuberosity and reshaped and inserted in the extraction socket |
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 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 autogenous bone block graftAtraumatic extraction of non restorable tooth, then the autogenous bone block graft will be harvested from the maxillary tuberosity and reshaped and inserted into the socket | Procedure or surgery | Alveolar ridge preservation using autogenous bone block 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 (Jung et al., 2013)
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 2 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 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.
- Background: PubMed 32099685Younes R, Khairallah CM. The "One Piece" Autologous Tuberosity Graft: A Contemporary Concept in Ridge Preservation. Case Rep Dent. 2020 Feb 13;2020:3945076. doi: 10.1155/2020/3945076. eCollection 2020.
- 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.
- 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 autogenous bone block 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 2 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 NCT05347017, which also lists 5 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 2 May 2022.