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

Study Overview
=================
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).

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

Conditions
-----------------
Surgery, Oral

Intervention / Treatment
-----------------
* Device: Plenum® Guide
* Device: Plenum® Oss
* Procedure: Tooth extraction


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: socket<br>Tooth extraction socket filled only clot. | Procedure: Tooth extraction<br>* Tooth extraction and subsequent surgical procedure of guided bone regeneration.<br>* Other names: Guided bone regeneration;|
| Active Comparator: Socket associated with exposed absorbable membrane<br>Socket filled with clot and covered with the Plenum® Guide membrane exposed in the intraoral region. | Device: Plenum® Guide<br>* Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.<br>* Other names: PDO absorbable membrane;Procedure: Tooth extraction<br>* Tooth extraction and subsequent surgical procedure of guided bone regeneration.<br>* Other names: Guided bone regeneration;|
| Active Comparator: Socket associated with covered absorbable membrane<br>Socket filled with clot and covered with the Plenum® Guide membrane and covered by mucosa (gingival tissue) in the intraoral region. | Device: Plenum® Guide<br>* Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.<br>* Other names: PDO absorbable membrane;Procedure: Tooth extraction<br>* Tooth extraction and subsequent surgical procedure of guided bone regeneration.<br>* Other names: Guided bone regeneration;|
| Experimental: Socket filled with synthetic bone graft and covered absorbable membrane<br>Socket filled with synthetic bone graft and the Plenum® Guide membrane covered by gingival tissue in the intraoral region. | Device: Plenum® Guide<br>* Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.<br>* Other names: PDO absorbable membrane;Device: Plenum® Oss<br>* Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.<br>* Other names: Synthetic bone graft;Procedure: Tooth extraction<br>* Tooth extraction and subsequent surgical procedure of guided bone regeneration.<br>* Other names: Guided bone regeneration;|
| Experimental: Socket filled with synthetic bone graft and exposed absorbable membrane<br>Socket filled with synthetic bone graft and Plenum® Guide membrane, where this membrane will be exposed in the intraoral region. | Device: Plenum® Guide<br>* Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.<br>* Other names: PDO absorbable membrane;Device: Plenum® Oss<br>* Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.<br>* Other names: Synthetic bone graft;Procedure: Tooth extraction<br>* Tooth extraction and subsequent surgical procedure of guided bone regeneration.<br>* Other names: Guided bone regeneration;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Guided bone regeneration, Resorbable membrane, Plenum® Guide, Dental implant, Extraction socket preservation