Alveolar Ridge PreservationPhase 1/2JUHNCT06827665
Clinical and Radiographic Evaluation of Allogenic Dentin Grafts for Alveolar Ridge Preservation
A Phase 1/2 study testing DDA and WTA in people with Alveolar Ridge Preservation, run by Jordan University Hospital at 1 site in Jordan.
Trial summary
For the first time, allografts from human-extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- DDA and WTA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jan 2025to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Students, interns, or residents willing to participate and provide informed consent.
- No history of systemic diseases such as diabetes, hepatitis, or immune disorders.
- Negative blood screening for HIV, HBV, and HCV.
- Non-smokers or individuals who have not smoked within the last six months.
- Patients aged 18-60 years, requiring extraction of at least three teeth for clinical or therapeutic reasons.
- Patients in good systemic health without conditions that impair bone healing.
- Willingness to provide informed consent and participate in follow-ups.
Who cannot join
- History of systemic conditions affecting oral or overall health.
- Positive blood tests for communicable diseases.
- Active oral infections or untreated dental caries.
- Pregnant or lactating individuals.
- Individuals with a history of smoking or substance abuse within the last six months.
- Systemic conditions such as diabetes, osteoporosis, or immunodeficiency that could impair bone regeneration.
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- Active oral infections at extraction sites.
- History of radiation therapy to the head and neck region.
- Smoking or smoking history within the last six months.
- Use of medications affecting bone metabolism (e.g., bisphosphonates, steroids).
- Pregnancy or lactation. Additional Justification for Extraction: Teeth chosen for extraction must meet one or more criteria:
- Severe periodontal disease.
- Irreversible pulpitis or structural damage.
- Non-restorable condition impacting oral health or functionality.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
Jordan University Hospital
Amman, 00962
Soukaina Ryalat, Prof, 00962795484463, salryalat@yahoo.com
About this study
Official title: Clinical and Radiographic Evaluation of Allogenic Dentin Grafts for Alveolar Ridge Preservation: A Prospective Clinical Trial
For the first time, allografts from human-extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation.
Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts from healthy human donors present a scalable solution. This study aims to evaluate the biocompatibility and effectiveness of two types of allogenic dentin grafts-demineralized dentin allografts (DDA) and whole tooth allografts (WTA)-for alveolar ridge preservation, contributing to innovative, sustainable dental practices.
Read the detailed description
This study holds significant importance for the fields of dentistry and maxillofacial surgery, addressing key clinical, scientific, and practical challenges:
- Innovative Approach to Ridge Preservation o By evaluating allogenic dentin grafts for alveolar ridge preservation, this study introduces an innovative solution for post-extraction bone regeneration, offering a sustainable alternative to conventional grafting methods.
- Addressing Limitations of Autogenous Grafts o Autogenous bone grafts, while effective, are limited by availability, patient acceptance, and donor site morbidity. Allogenic dentin grafts overcome these limitations, providing a readily available, safe, and effective option.
- Sustainable Utilization of Extracted Teeth o Extracted teeth are typically discarded as biomedical waste. This study demonstrates their potential to be repurposed as valuable graft materials, promoting sustainability and reducing waste in dental practices.
- Expanding the Body of Knowledge o There is limited research on allogenic dentin grafts compared to autogenous or xenogenic grafts. This study contributes valuable clinical and radiographic data, addressing a significant gap in the literature and paving the way for future research.
- Clinical Relevance for Prosthetic Rehabilitation o Successful alveolar ridge preservation is critical for subsequent prosthetic treatments, including implants and dentures. This study provides evidence-based insights into new methods that improve outcomes for patients.
- Potential for Broader Applications o By validating the efficacy of allogenic dentin grafts, this research supports the development of standardized protocols for their preparation and use, potentially expanding their application beyond ridge preservation to other bone regeneration procedures.
- Encouraging Tissue Banking and Collaboration
- Conditions
- Alveolar Ridge Preservation
- Being tested
- DDA, WTA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDABiological
Also called demineralized dentin allografts (DDA)
: demineralized dentin allografts (DDA) allografts from human extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts, derived from healthy human donors, present a scalable solution.
WTABiological
Also called Whole tooth allografts (WTA)
whole tooth allografts (WTA) allografts from human extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts, derived from healthy human donors, present a scalable solution.
| Study group | Role | What they receive |
|---|---|---|
| DDA | Experimental | demineralized dentin allografts (DDA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices Receives: Biological: DDA |
| WTA | Experimental | Whole tooth allografts (WTA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices Receives: Biological: WTA |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar ridge width and height (in mm) from baseline to 3 months post-extraction, measured using CBCT scans.
Measured: 3 months
Secondary outcomes (1)
Change in alveolar crest height and width (in mm) from baseline to 3 months post-extraction, measured using CBCT scans, comparing DDA, WTA, and ungrafted control sites.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Jan 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- hanan Jafar
- Responsible party
- Principal investigator, Soukaina Ryalat, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827665
- Sponsor's protocol ID
- DDA-WTA-JUH
- Acronym
- JUH
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Allogenic Dentin Grafts for Alveolar Ridge Preservation: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06827665
- Acronym / sponsor ID
- JUH / DDA-WTA-JUH
- Conditions
- Alveolar Ridge Preservation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jordan University HospitalUniversity, hospital or other
- Collaborators
- hanan Jafar
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Feb 2025 (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.
For the first time, allografts from human-extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation.
Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts from healthy human donors present a scalable solution. This study aims to evaluate the biocompatibility and effectiveness of two types of allogenic dentin grafts-demineralized dentin allografts (DDA) and whole tooth allografts (WTA)-for alveolar ridge preservation, contributing to innovative, sustainable dental practices.
Detailed description
This study holds significant importance for the fields of dentistry and maxillofacial surgery, addressing key clinical, scientific, and practical challenges:
- Innovative Approach to Ridge Preservation o By evaluating allogenic dentin grafts for alveolar ridge preservation, this study introduces an innovative solution for post-extraction bone regeneration, offering a sustainable alternative to conventional grafting methods.
- Addressing Limitations of Autogenous Grafts o Autogenous bone grafts, while effective, are limited by availability, patient acceptance, and donor site morbidity. Allogenic dentin grafts overcome these limitations, providing a readily available, safe, and effective option.
- Sustainable Utilization of Extracted Teeth o Extracted teeth are typically discarded as biomedical waste. This study demonstrates their potential to be repurposed as valuable graft materials, promoting sustainability and reducing waste in dental practices.
- Expanding the Body of Knowledge o There is limited research on allogenic dentin grafts compared to autogenous or xenogenic grafts. This study contributes valuable clinical and radiographic data, addressing a significant gap in the literature and paving the way for future research.
- Clinical Relevance for Prosthetic Rehabilitation o Successful alveolar ridge preservation is critical for subsequent prosthetic treatments, including implants and dentures. This study provides evidence-based insights into new methods that improve outcomes for patients.
- Potential for Broader Applications o By validating the efficacy of allogenic dentin grafts, this research supports the development of standardized protocols for their preparation and use, potentially expanding their application beyond ridge preservation to other bone regeneration procedures.
- Encouraging Tissue Banking and Collaboration
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DDA | Experimental | Biological: DDAdemineralized dentin allografts (DDA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices |
| WTA | Experimental | Biological: WTAWhole tooth allografts (WTA) will be given for alveolar ridge preservation, contributing to innovative, sustainable dental practices |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Students, interns, or residents willing to participate and provide informed consent.
- No history of systemic diseases such as diabetes, hepatitis, or immune disorders.
- Negative blood screening for HIV, HBV, and HCV.
- Non-smokers or individuals who have not smoked within the last six months.
- Patients aged 18-60 years, requiring extraction of at least three teeth for clinical or therapeutic reasons.
Key exclusion criteria (14 listed)
- History of systemic conditions affecting oral or overall health.
- Positive blood tests for communicable diseases.
- Active oral infections or untreated dental caries.
- Pregnant or lactating individuals.
- Individuals with a history of smoking or substance abuse within the last six months.
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 |
|---|---|---|
| DDAAlso: demineralized dentin allografts (DDA): demineralized dentin allografts (DDA) allografts from human extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts, derived from healthy human donors, present a scalable solution. | Biological | DDA |
| WTAAlso: Whole tooth allografts (WTA)whole tooth allografts (WTA) allografts from human extracted teeth will be prepared and evaluated in a prospective clinical trial to assess their efficacy for alveolar ridge preservation. The reconstruction and preservation of the alveolar ridge after tooth extraction are essential for future prosthetic rehabilitation. Autogenous bone grafts, while effective, are limited by donor site morbidity and insufficient graft quantity. Allogenic dentin grafts, derived from healthy human donors, present a scalable solution. | Biological | WTA |
Primary outcome
Change in alveolar ridge width and height (in mm) from baseline to 3 months post-extraction, measured using CBCT scans.
Time frame: 3 months
1 secondary outcome
Change in alveolar crest height and width (in mm) from baseline to 3 months post-extraction, measured using CBCT scans, comparing DDA, WTA, and ungrafted control sites.
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DDA and WTA in people with Alveolar Ridge Preservation, run by Jordan University Hospital at 1 site in Jordan.
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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. 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 Jordan. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soukaina Ryalat, Prof (00962795484463, salryalat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar ridge width and height (in mm) from baseline to 3 months post-extraction, measured using CBCT scans. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2025.