Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction

March 11, 2024 updated by: M3 Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Possess the four bone walls after the extraction procedure;
  • Over 18 years old;
  • And who have signed the TCLE.

Exclusion Criteria:

  • Uncontrolled systemic impairments;
  • Teeth in areas of tumor lesions;
  • Acute infectious processes;
  • Deciduous dental elements;
  • Untreated periodontal problems;
  • Smokers;
  • Radiated in the head or neck region;
  • Allergy to any component used in the research;
  • Psychological disorders;
  • Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: socket
Tooth extraction socket filled only clot.
Procedure: Tooth extraction
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
Other Names:
  • Guided bone regeneration
Active Comparator: Socket associated with exposed absorbable membrane
Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
Procedure: Tooth extraction
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
Other Names:
  • Guided bone regeneration
Device: Plenum® Guide
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
Other Names:
  • PDO absorbable membrane
Active Comparator: Socket associated with covered absorbable membrane
Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region.
Procedure: Tooth extraction
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
Other Names:
  • Guided bone regeneration
Device: Plenum® Guide
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
Other Names:
  • PDO absorbable membrane
Experimental: Socket filled with synthetic bone graft and covered absorbable membrane
Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
Procedure: Tooth extraction
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
Other Names:
  • Guided bone regeneration
Device: Plenum® Guide
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
Other Names:
  • PDO absorbable membrane
Device: Plenum® Oss
Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.
Other Names:
  • Synthetic bone graft
Experimental: Socket filled with synthetic bone graft and exposed absorbable membrane
Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
Procedure: Tooth extraction
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
Other Names:
  • Guided bone regeneration
Device: Plenum® Guide
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
Other Names:
  • PDO absorbable membrane
Device: Plenum® Oss
Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.
Other Names:
  • Synthetic bone graft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 4 months after extraction
immunohistochemical analyzes of histological sections
4 months after extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M3 Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
São Paulo State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sybele Saska Specian, PhD, Study Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Plenum Guide

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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