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

NCT06015906 — Not applicable, Recruiting, 150 participants, M3 Health

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Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction: a Clinical Trial

Registry	NCT06015906
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	150 (Estimated)
Sponsor	M3 Health (Industry); collaborators: São Paulo State University
Conditions	Surgery, Oral
Interventions	Plenum® Guide, Plenum® Oss, Tooth extraction (Device, procedure)
Dates	start 2024-04-01, primary completion 2026-10-07, completion 2026-12-01 (estimated), first posted 2023-08-29, last updated 2026-10-20
Locations	1 site in Brazil

-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.

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+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).

+Arms and interventions

Arm	Type	Interventions	Description
socket	Sham comparator	Procedure: Tooth extraction	Tooth extraction socket filled only clot.
Socket associated with exposed absorbable membrane	Active comparator	Device: Plenum® Guide; Procedure: Tooth extraction	Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region.
Socket associated with covered absorbable membrane	Active comparator	Device: Plenum® Guide; Procedure: 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	Experimental	Device: Plenum® Guide; Device: Plenum® Oss; Procedure: Tooth extraction	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 exposed absorbable membrane	Experimental	Device: Plenum® Guide; Device: Plenum® Oss; Procedure: Tooth extraction	Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region.

Plenum® Guide (Device), also known as PDO absorbable membrane: Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
Plenum® Oss (Device), also known as Synthetic bone graft: Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.
Tooth extraction (Procedure), also known as Guided bone regeneration: Tooth extraction and subsequent surgical procedure of guided bone regeneration.

+Outcome measures

Primary outcomes

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
Rate of newly formed bone tissue, soft tissue and residual bone graft material [4 months after extraction]: immunohistochemical analyzes of histological sections

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Faculdade de Odontologia de Araraquara	Araraquara, São Paulo	Brazil	Recruiting

+Investigators

Sybele Saska Specian, PhD, Study director, Study Director