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

NCT06015906 | Unknown DMC

• 1 other identifier: Plenum Guide
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgery, Oral

Keywords

Guided bone regeneration; Resorbable membrane; Plenum® Guide; Dental implant; Extraction socket preservation

Outcome Measures

Primary Outcomes (2)

• Rate of alveolar repair

  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

  immunohistochemical analyzes of histological sections

  4 months after extraction

Study Arms (5)

socket

SHAM COMPARATOR

Tooth extraction socket filled only clot.

Procedure: Tooth extraction

Socket associated with exposed absorbable membrane

ACTIVE COMPARATOR

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

Device: Plenum® Guide; Procedure: Tooth extraction

Socket associated with covered absorbable membrane

ACTIVE COMPARATOR

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

Device: Plenum® Guide; Procedure: Tooth extraction

Socket filled with synthetic bone graft and covered absorbable membrane

EXPERIMENTAL

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

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

Socket filled with synthetic bone graft and exposed absorbable membrane

EXPERIMENTAL

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

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

Interventions

Plenum® Guide DEVICE

Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.

Also known as: PDO absorbable membrane

Socket associated with covered absorbable membrane; Socket associated with exposed absorbable membrane; Socket filled with synthetic bone graft and covered absorbable membrane; Socket filled with synthetic bone graft and exposed absorbable membrane

Plenum® Oss DEVICE

Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.

Also known as: Synthetic bone graft

Socket filled with synthetic bone graft and covered absorbable membrane; Socket filled with synthetic bone graft and exposed absorbable membrane

Tooth extraction PROCEDURE

Tooth extraction and subsequent surgical procedure of guided bone regeneration.

Also known as: Guided bone regeneration

Socket associated with covered absorbable membrane; Socket associated with exposed absorbable membrane; Socket filled with synthetic bone graft and covered absorbable membrane; Socket filled with synthetic bone graft and exposed absorbable membrane; socket

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M3 Health: lead
• São Paulo State University: collaborator

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Sybele Saska Specian, PhD

  Study Director

  STUDY DIRECTOR

Central Study Contacts

Eduardo Hochuli Vieira, PhD

CONTACT

+55(16)3301-6459; eduardo.hochuli@unesp.br

Sybele Saska Specian, PhD

CONTACT

+55(11)31099068; pesquisa@plenum.bio

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share