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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

150

Phase

  • 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 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

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
Intervention / Treatment
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

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

M3 Health

Collaborators

São Paulo State University

Investigators

  • 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)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID 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.

Clinical Trials on Surgery, Oral

Clinical Trials on Tooth extraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe