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

NCT06015906 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-12

No results posted yet for this study

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. 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.

Conditions

  • Surgery, Oral

Interventions

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.

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.

PROCEDURE

Tooth extraction

Tooth extraction and subsequent surgical procedure of guided bone regeneration.

Sponsors & Collaborators

  • São Paulo State University

    collaborator OTHER

  • M3 Health

    lead INDUSTRY

Principal Investigators

  • Sybele Saska Specian, PhD · Study Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-06-30
Completion
2024-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06015906 on ClinicalTrials.gov