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

Surgery, Oral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015906
• Other study ID #: Plenum Guide
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: M3 Health
• Contact: Eduardo Hochuli Vieira, PhD
• Phone: +55(16)3301-6459
• Email: eduardo.hochuli[@]unesp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Surgery, Oral

Intervention

Device:
• Plenum® Guide
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
• Plenum® Oss
Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
M3 Health	São Paulo State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Rate of newly formed bone tissue, soft tissue and residual bone graft material	immunohistochemical analyzes of histological sections	4 months after extraction