Socket PreservationBM-HIS-SPNCT06740110
Bone Material's Histomorphometric Analysis In Socket Preservation
A study testing Tooth extraction and GBR procedure in people with Socket Preservation, run by Medical Inventi S.A. at 4 sites in Poland.
Trial summary
This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after 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
- Socket Preservation
- What is being tested?
- Tooth extraction and GBR procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 4 sitesPoland
- Study dates
- 1 Oct 2025to 30 Jan 2027
- Phase
- Interventional
- 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
- Patients over 18 years old with full legal capacity, male and female;
- Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
- Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
- Patients who respect the follow-up recalls.
Who cannot join
- Presence of bone lesions;
- Patients with alcohol or substance abuse;
- Patients with smoking habits (more than 10 cigarettes per day);
- Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
- Pregnant or breast feeding women;
- Patients currently participating in any other clinical investigation.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Indywidualna Praktyka Stomatologiczna Marek Śmielecki
Gniezno, 62-200
Medicare
Mińsk Mazowiecki, 05-300
Stomatologia Niteckie Sp. z o.o.
Tychy, 43-100
Rafał Dobrakowski Dentysta
Wroclaw, 53-030
About this study
Official title: A Histomorphometric Analysis of Bone Formation With Two Different Bone Graft Material in Adult Patients Required Socket Preservation After Tooth Extraction
This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.
- Conditions
- Socket Preservation
- Being tested
- Tooth extraction and GBR procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction and GBR procedureDevice
The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device (first arm) or standard of care (second arm) and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device, and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. Receives: Device: Tooth extraction and GBR procedure |
| Standard of care arm | Active comparator | The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places standard of care device and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. Receives: Device: Tooth extraction and GBR procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.
A new bone formation assesses via histomorphometric evaluation.
Measured: 6 months
Secondary outcomes (1)
Evaluation of (serious) adverse events (S)AEs.
Number of (S)AEs
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Oct 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Inventi S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740110
- Sponsor's protocol ID
- PC-MD-CIP-003
- Acronym
- BM-HIS-SP
- Status last verified
- Jun 2025
- First submitted
- 12 Dec 2024
- Last updated
- 30 Jan 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Histomorphometric Analysis of Bone Formation With Two Different Bone Graft Material in Adult Patients Required Socket Preservation After Tooth Extraction
- ClinicalTrials.gov ID
- NCT06740110
- Acronym / sponsor ID
- BM-HIS-SP / PC-MD-CIP-003
- Conditions
- Socket Preservation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Medical Inventi S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 18 Dec 2024 (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.
This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Tooth extraction and GBR procedureThe intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device, and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. |
| Standard of care arm | Active comparator | Device: Tooth extraction and GBR procedureThe intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places standard of care device and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years old with full legal capacity, male and female;
- Patients with ability to understand the proposed surgical treatment and to understand and sign the informed consent;
- Patients who are willing and able to comply with scheduled visits, treatment and other trial procedures;
- Patients who respect the follow-up recalls.
Key exclusion criteria (6 listed)
- Presence of bone lesions;
- Patients with alcohol or substance abuse;
- Patients with smoking habits (more than 10 cigarettes per day);
- Patients presenting physical and/or mental handicap that impede an adequate oral hygiene;
- Pregnant or breast feeding women;
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 |
|---|---|---|
| Tooth extraction and GBR procedureThe intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device (first arm) or standard of care (second arm) and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed. | Device | Interventional arm, Standard of care arm |
Primary outcome
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.
Time frame: 6 months
A new bone formation assesses via histomorphometric evaluation.
1 secondary outcome
Evaluation of (serious) adverse events (S)AEs.
Time frame: 13 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 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Socket Preservation
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Effect of Collagen Membrane on Ridge Preservation
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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction and GBR procedure in people with Socket Preservation, run by Medical Inventi S.A. at 4 sites in Poland.
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 6 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. 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?
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?
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure. (time frame: 6 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 30 Jan 2026.