Extracting Own TeethPhase 1NCT07269990
Evaluation of Bone Behavior in Maxillary Post-extractive Sites Treated With Guided Bone Regeneration (G.B.R.) Techniques in Alveolar Socket Preservation (A.S.P.) Procedures With Different Autologous and Heterologous Biomaterials.
A Phase 1 study testing compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2, Comparison of different types of biomaterials 4 months after application through the use of ASP and Comparison different types of biomaterials 4 months after application through the use of ASP in people with Extracting Own Teeth, run by University of Foggia at 1 site in Italy.
Trial summary
The maxillary bone atrophies from traumatic, pathological events or related to physiological bone loss after tooth extraction, promoting a decrease in bone volume (vertical-horizontal) which has always been a crucial challenge for the clinician in order to obtain adequate rehabilitations prosthetics. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Extracting Own Teeth
- What is being tested?
- compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2, Comparison of different types of biomaterials 4 months after application through the use of ASP and Comparison different types of biomaterials 4 months after application through the use of ASP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2023to May 2026
- Phase
- Phase 1
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients.
- Diagnosis of tooth extraction in the upper or lower jaw.
- Preservation procedures necessary to preserve jawbone volume with Guided
- Bone regeneration with autologous or heterologous biomaterials.
Who cannot join
- Patients with high risk of receiving the intervention (pre-existing medical conditions/comorbidities/possible adverse events).
- Patients with conditions that may interfere with the evaluation or confound the results. (e.g. they are already taking treatments)
- Patients with refusal to participate, inability to provide data, or at high risk of loss to follow-up.
- Patients with neoplastic pathologies.
- Patients with Radio-Chemo therapies.
Trial locations and contacts
1 site in 1 country.
About this study
The maxillary bone atrophies from traumatic, pathological events or related to physiological bone loss after tooth extraction, promoting a decrease in bone volume (vertical-horizontal) which has always been a crucial challenge for the clinician in order to obtain adequate rehabilitations prosthetics.
The results of bone loss induced aesthetic and functional difficulties in achieving surgical and prosthetic rehabilitation of the right dental implant.
Read more
Bone loss can be restored with autologous bone grafts and in large bone atrophy of the jaws require complex surgical techniques such as vascularized bone transplantation.
As an alternative to the reconstruction of the maxillary tissue, several surgical techniques have been promoted to prevent or minimize bone resorption through market biomaterials with or without the patient's autologous bone.
To reduce or counteract biological bone resorption, surgeons have promoted alveolar cavity preservation procedures (ASP) with autologous or heterologous graft materials.
Recently, several studies have been published to evaluate the use of demineralized dentin material derived from the extracted tooth to obtain new bone in the maxillary post-extraction site.
The aim of the study is to compare different types of biomaterials 4 months after application through the use of the alveolar socket preservation technique.
- Conditions
- Extracting Own Teeth
- Being tested
- compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2, Comparison of different types of biomaterials 4 months after application through the use of ASP, Comparison different types of biomaterials 4 months after application through the use of ASP, The aim is to compare different types of biomaterials 4 months after application through the use of ASP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2Procedure or surgery
The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 1
Comparison of different types of biomaterials 4 months after application through the use of ASPProcedure or surgery
The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 2
Comparison different types of biomaterials 4 months after application through the use of ASPBiological
The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 3
The aim is to compare different types of biomaterials 4 months after application through the use of ASPProcedure or surgery
The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 4
The aim is to compare different types of biomaterials 4 months after application through the use of ASPProcedure or surgery
The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 5
| Study group | Role | What they receive |
|---|---|---|
| compare different types of biomaterials 4 months after application through the use of ASP Group 1 | Active comparator | Not described Receives: Procedure: compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2 |
| compare different types of biomaterials 4 months after application through the use of ASP Group 2 | Active comparator | Not described Receives: Procedure: Comparison of different types of biomaterials 4 months after application through the use of ASP |
| compare different types of biomaterials 4 months after application through the use of ASP Group 3 | Active comparator | Not described Receives: Biological: Comparison different types of biomaterials 4 months after application through the use of ASP |
| compare different types of biomaterials 4 months after application through the use of ASP Group 4 | Active comparator | Not described Receives: Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP |
| compare different types of biomaterials 4 months after application through the use of ASP Group 5 | Active comparator | Not described Receives: Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of different biomaterials at 4 months to assess the percentage of residual biomaterial remaining in situ and the percentage of newly formed bone in the regenerated area.
Measured: 4 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start3 Jul 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracting Own TeethStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiberto Mastrangelo, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269990
- Sponsor's protocol ID
- 7-CE-2023
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Behavior in Maxillary Post-extractive Sites Treated With Guided Bone Regeneration (G.B.R.) Techniques in Alveolar Socket Preservation (A.S.P.) Procedures With Different Autologous and Heterologous Biomaterials.
- ClinicalTrials.gov ID
- NCT07269990
- Acronym / sponsor ID
- 7-CE-2023
- Conditions
- Extracting Own Teeth
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 8 Dec 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.
The maxillary bone atrophies from traumatic, pathological events or related to physiological bone loss after tooth extraction, promoting a decrease in bone volume (vertical-horizontal) which has always been a crucial challenge for the clinician in order to obtain adequate rehabilitations prosthetics.
The results of bone loss induced aesthetic and functional difficulties in achieving surgical and prosthetic rehabilitation of the right dental implant.
Bone loss can be restored with autologous bone grafts and in large bone atrophy of the jaws require complex surgical techniques such as vascularized bone transplantation.
As an alternative to the reconstruction of the maxillary tissue, several surgical techniques have been promoted to prevent or minimize bone resorption through market biomaterials with or without the patient's autologous bone.
To reduce or counteract biological bone resorption, surgeons have promoted alveolar cavity preservation procedures (ASP) with autologous or heterologous graft materials.
Recently, several studies have been published to evaluate the use of demineralized dentin material derived from the extracted tooth to obtain new bone in the maxillary post-extraction site.
The aim of the study is to compare different types of biomaterials 4 months after application through the use of the alveolar socket preservation technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| compare different types of biomaterials 4 months after application through the use of ASP Group 1 | Active comparator | Procedure: compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2 |
| compare different types of biomaterials 4 months after application through the use of ASP Group 2 | Active comparator | Procedure: Comparison of different types of biomaterials 4 months after application through the use of ASP |
| compare different types of biomaterials 4 months after application through the use of ASP Group 3 | Active comparator | Biological: Comparison different types of biomaterials 4 months after application through the use of ASP |
| compare different types of biomaterials 4 months after application through the use of ASP Group 4 | Active comparator | Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP |
| compare different types of biomaterials 4 months after application through the use of ASP Group 5 | Active comparator | Procedure: The aim is to compare different types of biomaterials 4 months after application through the use of ASP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy patients.
- Diagnosis of tooth extraction in the upper or lower jaw.
- Preservation procedures necessary to preserve jawbone volume with Guided
- Bone regeneration with autologous or heterologous biomaterials.
Key exclusion criteria (5 listed)
- Patients with high risk of receiving the intervention (pre-existing medical conditions/comorbidities/possible adverse events).
- Patients with conditions that may interfere with the evaluation or confound the results. (e.g. they are already taking treatments)
- Patients with refusal to participate, inability to provide data, or at high risk of loss to follow-up.
- Patients with neoplastic pathologies.
- Patients with Radio-Chemo therapies.
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 |
|---|---|---|
| compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2The aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 1 | Procedure or surgery | compare different types of biomaterials 4 months after application through the use of ASP Group 1 |
| Comparison of different types of biomaterials 4 months after application through the use of ASPThe aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 2 | Procedure or surgery | compare different types of biomaterials 4 months after application through the use of ASP Group 2 |
| Comparison different types of biomaterials 4 months after application through the use of ASPThe aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 3 | Biological | compare different types of biomaterials 4 months after application through the use of ASP Group 3 |
| The aim is to compare different types of biomaterials 4 months after application through the use of ASPThe aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 4 | Procedure or surgery | compare different types of biomaterials 4 months after application through the use of ASP Group 4 |
| The aim is to compare different types of biomaterials 4 months after application through the use of ASPThe aim is to compare different types of biomaterials 4 months after application through the use of ASP in Group 5 | Procedure or surgery | compare different types of biomaterials 4 months after application through the use of ASP Group 5 |
Primary outcome
Comparison of different biomaterials at 4 months to assess the percentage of residual biomaterial remaining in situ and the percentage of newly formed bone in the regenerated area.
Time frame: 4 months after surgery
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 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing compare different types of biomaterials 4 months after application through the use of ASP compare different types of biomaterials 4 months after application through the use of ASP Group 2, Comparison of different types of biomaterials 4 months after application through the use of ASP and Comparison different types of biomaterials 4 months after application through the use of ASP in people with Extracting Own Teeth, run by University of Foggia at 1 site in Italy.
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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. 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 Italy. 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 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of different biomaterials at 4 months to assess the percentage of residual biomaterial remaining in situ and the percentage of newly formed bone in the regenerated area. (time frame: 4 months after surgery). 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 30 Apr 2026.