Dentin Graft, Alveolar Ridge PreservationPhase 4NCT06031298
Influence of Various Healing Intervals on Alveolar Ridge Preservation Using Demineralized Dentin Graft: A Randomized Clinical Trial
A Phase 4 study testing Dentin Graft in people with Dentin Graft, Alveolar Ridge Preservation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Statement of the problem: The alveolar ridge undergoes various remodeling processes following tooth extraction, but the ridge resorption continues over time, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation whether by dental implants or tooth supported prosthesis. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Graft, Alveolar Ridge Preservation
- What is being tested?
- Dentin Graft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Jan 2026
- Phase
- Phase 4
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically free patients (American Society of Anesthesiologists I; ASA I)
- Age range 20 - 50.
- Non-molar maxillary teeth indicated for extraction.
- Patients with extraction sockets having intact bony walls, or no more than one bony wall dehiscence not extending more than 50% of the total bone height
Who cannot join
- Teeth to be extracted or adjacent teeth associated with acute infections.
- Smokers.
- Patients with other conditions that may affect the treatment [uncontrolled diabetes mellitus (HbA1c >7.0), liver or kidney failure, any active oral or systemic acute infections, currently receiving chemo-or radiotherapy or a history of radiotherapy in the head and neck area, severe hematologic disorders].
- Pregnant and lactating females.
- Patients with history of lack of compliance to dental visits and unwillingness or inability to sign the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry - Ain Shams University
Cairo
About this study
Statement of the problem:
The alveolar ridge undergoes various remodeling processes following tooth extraction, but the ridge resorption continues over time, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation whether by dental implants or tooth supported prosthesis.
Read more
Aim of the study:
The aim of the study is to assess the influence of the different time intervals on the healing of the demineralized dentin graft in alveolar ridge preservation (ARP) procedures.
Materials and methods:
30 patients with hopeless teeth requiring extraction in maxillary non molar areas and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, ain shams university according to the inclusion criteria. They will be randomly allocated into three equal groups. Group A (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 12 weeks, group B (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 18 weeks and group C (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 24 weeks. Radiographic assessment will be done using CBCT to the arch of interest and another cone beam will be done prior to the implant placement at 11, 17 and 23 weeks based on the study group and a volumetric assessment will be done with digital subtraction. At the respective times core biopsy will be taken for the histological assessment, and the implant placement will be done with the implant primary stability recorded using Ostell. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.
- Being tested
- Dentin Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dentin GraftBiological
Dentin graft is a grafting technique of autogenous origin that uses the teeth extracted from the patient for the graft material preparation.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservation using demineralized dentin graft at 12 weeks. | Experimental | Not described Receives: Biological: Dentin Graft |
| Alveolar ridge preservation using demineralized dentin graft at 18 weeks | Active comparator | Not described Receives: Biological: Dentin Graft |
| Alveolar ridge preservation using demineralized dentin graft at 24 weeks | Active comparator | Not described Receives: Biological: Dentin Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Assessment
Radiographic dimensional changes of the alveolar ridge following ARP using CBCT
Measured: Baseline, 12, 18 & 24 months
Secondary outcomes (2)
Implant primary stability
Implant primary stability using Ostell device
Measured: Time of implant placement at each group
Histological Assessment
Histomorphometric analysis.
Measured: Core biopsy obtained at 12, 18 and 24 weeks for the different groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin Graft, Alveolar Ridge PreservationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031298
- Sponsor's protocol ID
- FDASU-REC 1254
- Status last verified
- Jan 2025
- First submitted
- 2 Sep 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Various Healing Intervals on Alveolar Ridge Preservation Using Demineralized Dentin Graft: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06031298
- Acronym / sponsor ID
- FDASU-REC 1254
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Sep 2023 (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.
Statement of the problem:
The alveolar ridge undergoes various remodeling processes following tooth extraction, but the ridge resorption continues over time, resulting in hard and soft tissue loss which complicates prosthodontic rehabilitation whether by dental implants or tooth supported prosthesis.
Aim of the study:
The aim of the study is to assess the influence of the different time intervals on the healing of the demineralized dentin graft in alveolar ridge preservation (ARP) procedures.
Materials and methods:
30 patients with hopeless teeth requiring extraction in maxillary non molar areas and requiring replacement with dental implants, will be enrolled and recruited from the outpatient clinic, faculty of dentistry, ain shams university according to the inclusion criteria. They will be randomly allocated into three equal groups. Group A (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 12 weeks, group B (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 18 weeks and group C (n=10) alveolar ridge preservation will be done with demineralized dentin graft and re-entry at 24 weeks. Radiographic assessment will be done using CBCT to the arch of interest and another cone beam will be done prior to the implant placement at 11, 17 and 23 weeks based on the study group and a volumetric assessment will be done with digital subtraction. At the respective times core biopsy will be taken for the histological assessment, and the implant placement will be done with the implant primary stability recorded using Ostell. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed. Data collected will be tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservation using demineralized dentin graft at 12 weeks. | Experimental | Biological: Dentin Graft |
| Alveolar ridge preservation using demineralized dentin graft at 18 weeks | Active comparator | Biological: Dentin Graft |
| Alveolar ridge preservation using demineralized dentin graft at 24 weeks | Active comparator | Biological: Dentin Graft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically free patients (American Society of Anesthesiologists I; ASA I)
- Age range 20 - 50.
- Non-molar maxillary teeth indicated for extraction.
- Patients with extraction sockets having intact bony walls, or no more than one bony wall dehiscence not extending more than 50% of the total bone height
Key exclusion criteria (5 listed)
- Teeth to be extracted or adjacent teeth associated with acute infections.
- Smokers.
- Patients with other conditions that may affect the treatment [uncontrolled diabetes mellitus (HbA1c >7.0), liver or kidney failure, any active oral or systemic acute infections, currently receiving chemo-or radiotherapy or a history of radiotherapy in the head and neck area, severe hematologic disorders].
- Pregnant and lactating females.
- Patients with history of lack of compliance to dental visits and unwillingness or inability to sign the informed consent.
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 |
|---|---|---|
| Dentin GraftDentin graft is a grafting technique of autogenous origin that uses the teeth extracted from the patient for the graft material preparation. | Biological | Alveolar ridge preservation using demineralized dentin graft at 12 weeks., Alveolar ridge preservation using demineralized dentin graft at 18 weeks, Alveolar ridge preservation using demineralized dentin graft at 24 weeks |
Primary outcome
Radiographic Assessment
Time frame: Baseline, 12, 18 & 24 months
Radiographic dimensional changes of the alveolar ridge following ARP using CBCT
2 secondary outcomes
Implant primary stability
Time frame: Time of implant placement at each group
Histological Assessment
Time frame: Core biopsy obtained at 12, 18 and 24 weeks for the different groups.
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 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Comparison of Demineralized and Mineralized Dentin Grafts in Ridge Preservation
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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 4 study testing Dentin Graft in people with Dentin Graft, Alveolar Ridge Preservation, run by Ain Shams 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 4 inclusion and 5 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 31 Jan 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mohamed A Mohamed (+201224005098, mohamed.mostafa@miuegypt.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Assessment (time frame: Baseline, 12, 18 & 24 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 31 Jan 2025.