Oral Surgical ProceduresNCT06136143

Plenum® Osshp in Maxillary Sinus Elevation Surgery

A study testing Group 1: Autogenous bone graft, Group 2: Plenum® Osshp and Group 3: Plenum® Osshp; + i-PRF in people with Oral Surgical Procedures, run by M3 Health at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Oral Surgical Procedures
What is being tested?: Group 1: Autogenous bone graft, Group 2: Plenum® Osshp and Group 3: Plenum® Osshp; + i-PRF
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteBrazil
Study dates: 1 Jun 2023to 30 Jan 2026
Phase: Interventional
Are there results?: None posted in the registry

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 with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
Over 18 years old;
And that they have signed the informed consent form.

Who cannot join

Smokers;
Patients with uncontrolled systemic diseases;
Patients with blood dyscrasias;
Patients with sinus pathologies;
Patients who take or have used medications that interfere with bone turnover;
Patients irradiated in the head and neck region;
Pregnant patients;
Patients with untreated periodontal disease.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Estadual Paulista - UNESP
Araraquara, São Paulo, 14800900

Other trials in Brazil

About this study

Official title: Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery

The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of Plenum® Osshp with i-PRF (i-PR - injectable platelet-rich fibrin). For this, forty (40) participants will be recruited, divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery, with the aid of a volumetric tomography machine for dentofacial images. The values obtained at T2 will be subtracted from those obtained from T1 to obtain the volumetric stability value. After six months of repair, biopsies will be performed using a trephine drill, followed by the installation of implants and healers. Through microcomputed tomography analysis, the parameters of bone volume fraction (BV/TV), total porosity (Po.Tot), trabecular thickness (Tb.Th), number of trabeculae (Tb.N) and separation of trabeculae (Tb.Sp) will be evaluated. Histomorphometric analysis will be performed to obtain the areas of bone neoformation, connective tissue and remaining biomaterial that will be calculated for each area of the sample (cervical, intermediate, and apical) and later summed, obtaining the total representative area of the sample. Through immunohistochemical analysis, specific primary antibodies to Runx2, VEGF, Osteocalcin (OC) and Tartrate-Resistant Acid Phosphatase (TRAP) will be identified. The occurrence of adverse events will be collected through the analysis of pain, infection, and edema. The quantitative results of the histomorphometric, microtomographic, and volumetric stability analysis will be tabulated and submitted to the ANOVA test, and if they present a statistically significant difference, it will be followed by the Tukey test (post hoc). A significance level of p<0.05 will be adopted for all tests.

Conditions: Oral Surgical Procedures
Being tested: Group 1: Autogenous bone graft, Group 2: Plenum® Osshp, Group 3: Plenum® Osshp; + i-PRF, Group 4: Plenum® Osshp + autogenous bone graft
Keywords: Maxillary Sinus, Synthetic Bone Graft, Autogenous Bone Graft, Platelet Rich Fibrin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group 1: Autogenous bone graftProcedure or surgery
Also called Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift
The maxillary sinus will be grafted with the autogenous bone graft.
Group 2: Plenum® OsshpProcedure or surgery
Also called Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device.
Group 3: Plenum® Osshp; + i-PRFProcedure or surgery
Also called Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with i-PRF.
Group 4: Plenum® Osshp + autogenous bone graftProcedure or surgery
Also called Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus lift
The maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.

Study groups in NCT06136143
Study group	Role	What they receive
Group 1: Autogenous bone graft	Active comparator	The maxillary sinus will treated with autogenous bone graft. Receives: Procedure: Group 1: Autogenous bone graft
Group 2: Plenum® Osshp	Experimental	The maxillary sinus will treated with Plenum® Osshp. Receives: Procedure: Group 2: Plenum® Osshp
Group 3: Plenum® Osshp; + i-PRF	Experimental	The maxillary sinus will treated with Plenum® Osshp associated with i-PRF (i-PR - injectable platelet-rich fibrin). Receives: Procedure: Group 3: Plenum® Osshp; + i-PRF
Group 4: Plenum® Osshp + autogenous bone graft	Experimental	The maxillary sinus will treated with Plenum® Osshp associated with autogenous bone graft. Receives: Procedure: Group 4: Plenum® Osshp + autogenous bone graft

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of the maintenance of volume in the maxillary sinus region.
Computed tomography scans were performed and compared after graft surgery (T1) and after 6 months of repair (T2). The maintenance of the volume will be defined by the difference in the area of T2-T1.
Measured: Fifteen days (T1) and six months (T2) from postoperative.

Secondary outcomes (6)

Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.
Microcomputed tomography analysis using the following variables: Bone volume fraction, total porosity, trabecular thickness, number of trabeculae and separation of trabeculae.
Measured: Six months from postoperative.
Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.
Histomorphometric analysis of the experimental groups.
Measured: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Quantification of specific marker for Runx2.
Measured: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Quantification of specific marker for VEGF.
Measured: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Quantification of specific marker for Osteocalcin (OC)
Measured: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Quantification of specific marker for Tartrate-Resistant Acid Phosphatase (TRAP).
Measured: Six months from postoperative.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202330 Jan 2026

First posted18 Nov 2023
Study start1 Jun 2023
Primary completion30 May 2024
Study completion30 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oral Surgical ProceduresStudies 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
Model description: For this, forty (40) participants will be recruited for procedure surgery of maxillary sinus elevation and subsequent installation of dental implants after 06 months of postoperative. And then, the participants will divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06136143
Sponsor's protocol ID: Plenum Oss 001
Status last verified: Oct 2026
First submitted: 9 Nov 2023
Last updated: 20 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Oral Surgical Procedures trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind Randomized Controlled Clinical Study of the Predictability of Using Plenum® Osshp in Maxillary Sinus Elevation Surgery
ClinicalTrials.gov ID: NCT06136143
Acronym / sponsor ID: Plenum Oss 001
Conditions: Oral Surgical Procedures
Keywords: Maxillary Sinus, Synthetic Bone Graft, Autogenous Bone Graft, Platelet Rich Fibrin
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: M3 HealthIndustry (pharma, biotech, devices)
Collaborators: Universidade Estadual Paulista Júlio de Mesquita Filho
Study start: 1 Jun 2023 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 30 Jan 2026 (actual)
First posted: 18 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: For this, forty (40) participants will be recruited for procedure surgery of maxillary sinus elevation and subsequent installation of dental implants after 06 months of postoperative. And then, the participants will divided into 4 groups, which will have 10 participants each, namely: Group 1: Autogenous bone; Group 2: Plenum® Osshp; Group 3: Plenum® Osshp; + i-PRF and Group 4: Plenum® Osshp; + autogenous bone. To evaluate the primary outcome, volumetric analysis will be performed by obtaining computed tomography scans at 15 days (T1) and 6 months (T2) after graft surgery.

Arm	Type	Receives
Group 1: Autogenous bone graft	Active comparator	Procedure: Group 1: Autogenous bone graftThe maxillary sinus will treated with autogenous bone graft.
Group 2: Plenum® Osshp	Experimental	Procedure: Group 2: Plenum® OsshpThe maxillary sinus will treated with Plenum® Osshp.
Group 3: Plenum® Osshp; + i-PRF	Experimental	Procedure: Group 3: Plenum® Osshp; + i-PRFThe maxillary sinus will treated with Plenum® Osshp associated with i-PRF (i-PR - injectable platelet-rich fibrin).
Group 4: Plenum® Osshp + autogenous bone graft	Experimental	Procedure: Group 4: Plenum® Osshp + autogenous bone graftThe maxillary sinus will treated with Plenum® Osshp associated with autogenous bone graft.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with alveolar ridge atrophy, with bone remnant less than 5 mm in height, with adequate bone volume in the ramus and/or symphysis region;
Over 18 years old;
And that they have signed the informed consent form.

Key exclusion criteria (8 listed)

Smokers;
Patients with uncontrolled systemic diseases;
Patients with blood dyscrasias;
Patients with sinus pathologies;
Patients who take or have used medications that interfere with bone turnover;

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
Group 1: Autogenous bone graftAlso: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus liftThe maxillary sinus will be grafted with the autogenous bone graft.	Procedure or surgery	Group 1: Autogenous bone graft
Group 2: Plenum® OsshpAlso: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus liftThe maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device.	Procedure or surgery	Group 2: Plenum® Osshp
Group 3: Plenum® Osshp; + i-PRFAlso: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus liftThe maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with i-PRF.	Procedure or surgery	Group 3: Plenum® Osshp; + i-PRF
Group 4: Plenum® Osshp + autogenous bone graftAlso: Maxillary sinus elevation surgery, Maxillary sinus augmentation, Maxillary sinus liftThe maxillary sinus will be grafted with the Plenum Oss hp (Plenum, Brazil) medical device associated with autogenous bone graft.	Procedure or surgery	Group 4: Plenum® Osshp + autogenous bone graft

Primary outcome

Rate of the maintenance of volume in the maxillary sinus region.
Time frame: Fifteen days (T1) and six months (T2) from postoperative.
Computed tomography scans were performed and compared after graft surgery (T1) and after 6 months of repair (T2). The maintenance of the volume will be defined by the difference in the area of T2-T1.

6 secondary outcomes

Rate of the bone neoformation of the synthetic graft in comparison with the autogenous graft and in association with i-PRF.
Time frame: Six months from postoperative.
Rate of the areas of bone neoformation, connective tissue and remnant synthetic graft.
Time frame: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time frame: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time frame: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time frame: Six months from postoperative.
Rate of influence of the use of synthetic grafts on newly formed bone tissue, in comparison with autogenous grafts and in association with i-PRF.
Time frame: Six months from postoperative.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.

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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. This study is not recruiting at the moment.

Sybele Specian, PhD study director

Plenum (M3 Health)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group 1: Autogenous bone graft, Group 2: Plenum® Osshp and Group 3: Plenum® Osshp; + i-PRF in people with Oral Surgical Procedures, run by M3 Health at 1 site in Brazil.

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 8 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: finished, as of the sponsor's last update on 20 Oct 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 Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of the maintenance of volume in the maxillary sinus region. (time frame: Fifteen days (T1) and six months (T2) from postoperative.). 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 NCT06136143.

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 20 Oct 2026.