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

Not Applicable

Not yet recruiting

• Conditions: Surgery, Oral
• Interventions: Procedure: Tooth extraction; Device: Plenum® Guide; Device: Plenum® Oss

• Registration Number: NCT06015906
• Lead Sponsor: M3 Health

Brief 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.

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 Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-08-29
• Status Verified: 2023-10
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12
• Study Start: 2024-04
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
socket	Tooth extraction	Tooth extraction socket filled only clot.
Socket associated with exposed absorbable membrane	Tooth extraction	Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
Socket associated with covered absorbable membrane	Tooth extraction	Socket 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	Plenum® Guide	Socket 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 covered absorbable membrane	Plenum® Oss	Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
Socket associated with exposed absorbable membrane	Plenum® Guide	Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
Socket filled with synthetic bone graft and covered absorbable membrane	Tooth extraction	Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region.
Socket associated with covered absorbable membrane	Plenum® Guide	Socket 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 exposed absorbable membrane	Plenum® Oss	Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
Socket filled with synthetic bone graft and exposed absorbable membrane	Plenum® Guide	Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.
Socket filled with synthetic bone graft and exposed absorbable membrane	Tooth extraction	Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.

Primary Outcome Measures

Name	Time	Method
Rate of newly formed bone tissue, soft tissue and residual bone graft material	4 months after extraction	immunohistochemical analyzes of histological sections
Rate of alveolar repair	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