Surgery, Oral
Conditions
Keywords
Guided bone regeneration, Resorbable membrane, Plenum® Guide, Dental implant, Extraction socket preservation
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).
Interventions
DEVICEPlenum® Guide
Plenum® Guide is a white, absorbable synthetic regenerative membrane composed of poly(dioxanone), which will be installed on the tooth extraction sockets.
DEVICEPlenum® Oss
Plenum® Oss is a synthetic bone graft based on biphasic calcium phosphate, which will be used to fill the tooth extraction sockets.
PROCEDURETooth extraction
Tooth extraction and subsequent surgical procedure of guided bone regeneration.
Sponsors
São Paulo State University
M3 Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactEduardo Hochuli Vieira, PhD
Backup ContactSybele Saska Specian, PhD
Outcome results
None listed