Surgery, OralNCT06015906
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
A study testing Plenum® Guide, Plenum® Oss and Tooth extraction in people with Surgery, Oral, run by M3 Health at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Oral
- What is being tested?
- Plenum® Guide, Plenum® Oss and Tooth extraction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2024to Dec 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possess the four bone walls after the extraction procedure;
- Over 18 years old;
- And who have signed the TCLE.
Who cannot join
- Uncontrolled systemic impairments;
- Teeth in areas of tumor lesions;
- Acute infectious processes;
- Deciduous dental elements;
- Untreated periodontal problems;
- Smokers;
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- Radiated in the head or neck region;
- Allergy to any component used in the research;
- Psychological disorders;
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Faculdade de Odontologia de Araraquara
Araraquara, São Paulo, 14801-385
Beatriz Marinho, PhD candidate, 55+31992940009, beatriz.marinho@unesp.br
About this study
Official title: Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction: a Clinical Trial
The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. The main question it aims to answer is the effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration, exposed or not, through the preservation and neoformation of bone tissue in the tooth extraction socket procedures.
Read the detailed description
Patients will be submitted to tooth extraction, the surgical procedure of guided bone regeneration using regenerative membranes and synthetic bone graft, and subsequent installation of dental implants. The 05 groups will be compared to observe if the proposed medical devices effectively will maintain the socket's bone volume during the healing phase before the installation of the dental implants (1. socket filled only with clot, 2. socket associated with exposed absorbable membrane, 3. socket associated with covered absorbable membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5. socket filled with synthetic bone graft and exposed absorbable membrane).
- Conditions
- Surgery, Oral
- Being tested
- Plenum® Guide, Plenum® Oss, Tooth extraction
- Keywords
- Guided bone regeneration, Resorbable membrane, Plenum® Guide, Dental implant, Extraction socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plenum® GuideDevice
Also called PDO absorbable membrane
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
Plenum® OssDevice
Also called Synthetic bone graft
Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.
Tooth extractionProcedure or surgery
Also called Guided bone regeneration
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
| Study group | Role | What they receive |
|---|---|---|
| socket | Sham comparator | Tooth extraction socket filled only clot. Receives: Procedure: Tooth extraction |
| Socket associated with exposed absorbable membrane | Active comparator | Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region. Receives: Device: Plenum® Guide; Procedure: Tooth extraction |
| Socket associated with covered absorbable membrane | Active comparator | Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region. Receives: Device: Plenum® Guide; Procedure: Tooth extraction |
| Socket filled with synthetic bone graft and covered absorbable membrane | Experimental | Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region. Receives: Device: Plenum® Guide; Device: Plenum® Oss; Procedure: Tooth extraction |
| Socket filled with synthetic bone graft and exposed absorbable membrane | Experimental | Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region. Receives: Device: Plenum® Guide; Device: Plenum® Oss; Procedure: Tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of alveolar repair
Accessed via cone beam computed tomography
Measured: Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)
Rate of newly formed bone tissue, soft tissue and residual bone graft material
immunohistochemical analyzes of histological sections
Measured: 4 months after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Apr 2024
- Primary completion7 Oct 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery, OralStudies 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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M3 Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- São Paulo State University
- Responsible party
- Sponsor
- Investigators
- Sybele Saska Specian, PhD, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015906
- Sponsor's protocol ID
- Plenum Guide
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction: a Clinical Trial
- ClinicalTrials.gov ID
- NCT06015906
- Acronym / sponsor ID
- Plenum Guide
- Conditions
- Surgery, Oral
- Keywords
- Guided bone regeneration, Resorbable membrane, Plenum® Guide, Dental implant, Extraction socket preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M3 HealthIndustry (pharma, biotech, devices)
- Collaborators
- São Paulo State University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 7 Oct 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Aug 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.
The goal of this clinical trial is to compare the maintenance of socket volume in the groups treated by a resorbable regenerative membrane (Plenum® Guide) covered or not with mucous tissue, with control without treatment. The main question it aims to answer is the effectiveness of the Plenum® Guide membrane in the process of guided bone regeneration, exposed or not, through the preservation and neoformation of bone tissue in the tooth extraction socket procedures.
Detailed description
Patients will be submitted to tooth extraction, the surgical procedure of guided bone regeneration using regenerative membranes and synthetic bone graft, and subsequent installation of dental implants. The 05 groups will be compared to observe if the proposed medical devices effectively will maintain the socket's bone volume during the healing phase before the installation of the dental implants (1. socket filled only with clot, 2. socket associated with exposed absorbable membrane, 3. socket associated with covered absorbable membrane, 4. socket filled with synthetic bone graft and covered absorbable membrane, 5. socket filled with synthetic bone graft and exposed absorbable membrane).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| socket | Sham comparator | Procedure: Tooth extractionTooth extraction socket filled only clot. |
| Socket associated with exposed absorbable membrane | Active comparator | Device: Plenum® Guide, Procedure: Tooth extractionSocket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region. |
| Socket associated with covered absorbable membrane | Active comparator | Device: Plenum® Guide, Procedure: Tooth extractionSocket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region. |
| Socket filled with synthetic bone graft and covered absorbable membrane | Experimental | Device: Plenum® Guide, Device: Plenum® Oss, Procedure: Tooth extractionSocket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region. |
| Socket filled with synthetic bone graft and exposed absorbable membrane | Experimental | Device: Plenum® Guide, Device: Plenum® Oss, Procedure: Tooth extractionSocket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Possess the four bone walls after the extraction procedure;
- Over 18 years old;
- And who have signed the TCLE.
Key exclusion criteria (10 listed)
- Uncontrolled systemic impairments;
- Teeth in areas of tumor lesions;
- Acute infectious processes;
- Deciduous dental elements;
- Untreated periodontal problems;
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 |
|---|---|---|
| Plenum® GuideAlso: PDO absorbable membranePlenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets. | Device | Socket associated with covered absorbable membrane, Socket associated with exposed absorbable membrane, Socket filled with synthetic bone graft and covered absorbable membrane, Socket filled with synthetic bone graft and exposed absorbable membrane |
| Plenum® OssAlso: Synthetic bone graftPlenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets. | Device | Socket filled with synthetic bone graft and covered absorbable membrane, Socket filled with synthetic bone graft and exposed absorbable membrane |
| Tooth extractionAlso: Guided bone regenerationTooth extraction and subsequent surgical procedure of guided bone regeneration. | Procedure or surgery | Socket associated with covered absorbable membrane, Socket associated with exposed absorbable membrane, Socket filled with synthetic bone graft and covered absorbable membrane, Socket filled with synthetic bone graft and exposed absorbable membrane, socket |
Primary outcome
Rate of alveolar repair
Time frame: Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)
Accessed via cone beam computed tomography
Rate of newly formed bone tissue, soft tissue and residual bone graft material
Time frame: 4 months after extraction
immunohistochemical analyzes of histological sections
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 20 Oct 2026.
- 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.
Sybele Saska Specian, PhD study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plenum® Guide, Plenum® Oss and Tooth extraction in people with Surgery, Oral, 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 10 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 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. Some participants in this study may receive a placebo. 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?
Contact Eduardo Hochuli Vieira, PhD (+55(16)3301-6459, eduardo.hochuli@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of alveolar repair (time frame: Comparison of exams obtained in the preoperative period, immediate postoperative period (7 days) and late postoperative period (3 months)). The study lists 2 primary outcomes in all. 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 20 Oct 2026.