Tooth ExtractionEarly Phase 1BTCPARPBVNCT07638319
Assessment of the Impact of Neocement Inject P® (Beta-Tricalcium Phosphate) on Bone Volume in Alveolar Ridge Preservation After Tooth Extraction
A Early Phase 1 study testing Neocement Inject P® (Beta-Tricalcium Phosphate) in people with Tooth Extraction and Tooth Extraction Site Healing, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
The goal of this randomized clinical trial is to assess whether β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction, Tooth Extraction Site Healing, Alveolar Bone Grafting
- What is being tested?
- Neocement Inject P® (Beta-Tricalcium Phosphate)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Dec 2025to Dec 2028
- Phase
- Early 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Acceptance of informed consent
- Type 1 or 2 extraction sockets (Elian et al. 2007)
Who cannot join
- Presence of active infection or severe inflammation in the intervention zone
- Relevant medical history that contraindicates implant surgery
- Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation
- Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%)
- Uncontrolled and /or untreated periodontal disease
- Heavy smokers (more than 10 cigarettes per day)
- Immunosuppression
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Clinica Dentária Egas Moniz
Caparica, Monte Da Caparica, 2829-511
Angel Lobito, Masters' in Dentistry, 00351924347050, alobito@egasmoniz.edu.pt
About this study
Official title: Assessment of Safety and Performance of Neobone®: A Prospective Observational Study in the Field of Dentistry
The goal of this randomized clinical trial is to assess whether β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using β-TCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing.
The main questions it aims to answer are:
Read more
Does β-TCP improve ridge preservation compared with natural healing?
Researchers will compare β-TCP grafted sockets to natural healing sockets to see if β-TCP better preserves ridge volume.
Participants will:
Have a tooth indicated for extraction.
Be assigned to either β-TCP or natural healing.
Undergo CBCT (Cone Beam Computed Tomography) and intra-oral scanning after extraction and after six months of healing to measure horizontal and vertical resorption and bone density.
- Conditions
- Tooth Extraction, Tooth Extraction Site Healing, Alveolar Bone Grafting, Alveolar Bone Loss
- Being tested
- Neocement Inject P® (Beta-Tricalcium Phosphate)
- Keywords
- Beta-tricalcium phosphate, Alveolar ridge preservation, Bone volume, Implant site development, Socket preservation, Ridge augmentation, Tooth extraction, Volumetric Changes
- 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.
Neocement Inject P® (Beta-Tricalcium Phosphate)Device
After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate).
| Study group | Role | What they receive |
|---|---|---|
| Neocement Inject P® (Beta-Tricalcium Phosphate) | Experimental | After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate). Receives: Device: Neocement Inject P® (Beta-Tricalcium Phosphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar ridge volume after tooth extraction
Change in alveolar ridge volume after tooth extraction on sockets grafted with Beta-Tricalcium Phosphate
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Botelho, PhD in Biomedical Sciences, Study director, Clinical Research Unit (CRU), Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638319
- Sponsor's protocol ID
- EM1651
- Acronym
- BTCPARPBV
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mishchenko O, Yanovska A, Kosinov O, Maksymov D, Moskalenko R, Ramanavicius A, Pogorielov M. Synthetic Calcium-Phosphate Materials for Bone Grafting. Polymers (Basel). 2023 Sep 19;15(18):3822. doi: 10.3390/polym15183822.
PubMed 37765676
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Performance of Neobone®: A Prospective Observational Study in the Field of Dentistry
- ClinicalTrials.gov ID
- NCT07638319
- Acronym / sponsor ID
- BTCPARPBV / EM1651
- Conditions
- Tooth Extraction, Tooth Extraction Site Healing, Alveolar Bone Grafting, Alveolar Bone Loss
- Keywords
- Beta-tricalcium phosphate, Alveolar ridge preservation, Bone volume, Implant site development, Socket preservation, Ridge augmentation, Tooth extraction, Volumetric Changes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (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 goal of this randomized clinical trial is to assess whether β-TCP (Beta-Tricalcium Phosphate) improves alveolar ridge preservation (ARP) in patients who need tooth extraction. The main question it aims to answer is whether using β-TCP for alveolar ridge preservation has a positive effect on bone volume compared with natural healing.
The main questions it aims to answer are:
Does β-TCP improve ridge preservation compared with natural healing?
Researchers will compare β-TCP grafted sockets to natural healing sockets to see if β-TCP better preserves ridge volume.
Participants will:
Have a tooth indicated for extraction.
Be assigned to either β-TCP or natural healing.
Undergo CBCT (Cone Beam Computed Tomography) and intra-oral scanning after extraction and after six months of healing to measure horizontal and vertical resorption and bone density.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neocement Inject P® (Beta-Tricalcium Phosphate) | Experimental | Device: Neocement Inject P® (Beta-Tricalcium Phosphate)After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Acceptance of informed consent
- Type 1 or 2 extraction sockets (Elian et al. 2007)
Key exclusion criteria (7 listed)
- Presence of active infection or severe inflammation in the intervention zone
- Relevant medical history that contraindicates implant surgery
- Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation
- Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%)
- Uncontrolled and /or untreated periodontal disease
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 |
|---|---|---|
| Neocement Inject P® (Beta-Tricalcium Phosphate)After tooth extraction the socket will be grafted with Neocement Inject P® (Beta-Tricalcium Phosphate). | Device | Neocement Inject P® (Beta-Tricalcium Phosphate) |
Primary outcome
Change in alveolar ridge volume after tooth extraction
Time frame: From enrollment to the end of treatment at 6 months
Change in alveolar ridge volume after tooth extraction on sockets grafted with Beta-Tricalcium Phosphate
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 11 Jun 2026.
- Background: PubMed 37765676Mishchenko O, Yanovska A, Kosinov O, Maksymov D, Moskalenko R, Ramanavicius A, Pogorielov M. Synthetic Calcium-Phosphate Materials for Bone Grafting. Polymers (Basel). 2023 Sep 19;15(18):3822. doi: 10.3390/polym15183822.
- 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.
João Botelho, PhD in Biomedical Sciences study director
Clinical Research Unit (CRU), Egas Moniz Center for Interdisciplinary Research (CiiEM), Egas Moniz School of Health & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neocement Inject P® (Beta-Tricalcium Phosphate) in people with Tooth Extraction and Tooth Extraction Site Healing, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 7 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 11 Jun 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 Portugal. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Angel Lobito, Masters' in Dentistry (00351924347050, alobito@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alveolar ridge volume after tooth extraction (time frame: From enrollment to the end of treatment at 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 NCT07638319, which also lists 1 linked publication.
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 11 Jun 2026.