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

M3 Health

Status: Not yet enrolling

Conditions: Surgery, Oral

Treatments: Device: Plenum® Oss; Device: Plenum® Guide; Procedure: Tooth extraction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06015906

Plenum Guide

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

socket

Sham Comparator group

Description:

Tooth extraction socket filled only clot.

Treatment:

Procedure: Tooth extraction

Socket associated with exposed absorbable membrane

Active Comparator group

Description:

Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.

Treatment:

Procedure: Tooth extraction

Device: Plenum® Guide

Socket associated with covered absorbable membrane

Active Comparator group

Description:

Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region.

Treatment:

Procedure: Tooth extraction

Device: Plenum® Guide

Socket filled with synthetic bone graft and covered absorbable membrane

Experimental group

Description:

Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.

Treatment:

Procedure: Tooth extraction

Device: Plenum® Guide

Device: Plenum® Oss

Socket filled with synthetic bone graft and exposed absorbable membrane

Experimental group

Description:

Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.

Treatment:

Procedure: Tooth extraction

Device: Plenum® Guide

Device: Plenum® Oss