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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: M3 Health • ClinicalTrials.gov ID: NCT06015906

Registry updated: 2026-10-20
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Description

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.

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.
  • 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.
  • Tooth extraction (Procedure)
    Tooth extraction and subsequent surgical procedure of guided bone regeneration.

Eligibility criteria

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.

Conditions

Surgery, Oral

Locations

  • Faculdade de Odontologia de Araraquara — Araraquara, São Paulo, Brazil
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record