Loss of teeth due to accident, extraction or localized periodontal diseases
Conditions
Interventions
Thirty-six patients will be recruited with an indication for extraction of a dental element for subsequent rehabilitation through dental implants. The 36 recruited patients will be divided into 3 grou
Alveolus group associated with exposed absorbable membrane: 12 dental alveoli that will receive the polydioxanone membrane that will be exposed in the intra-oral region
and Alveolus group associated with covered absorbable membrane: 12 dental alveoli that will receive the polydioxanone membrane that will be covered by mucosa in the oral region. Extraction of teeth (
São Caetano do Sul, SP, Brazil) and the dental element will be dislocated using straight and curved levers (Quinelato
Rio Claro, SP, Brazil) with the necessary care to preserve the alveolar walls. Forceps No. 16, 17 and 151 will be used, if needed, as well as high-speed instruments for odontosection, which will be pe
Cotia, SP, Brazil) under constant irrigation with saline solution at 0.9 percent (Darrow
Rio de Janeiro, RJ, Brazil). Finally, the dental element will be avulsed, the dental alveolus will be copiously irrigated with 0.9 percent saline solution, and when necessary, filing and curettage wil
Sponsors
M3 Health Indústria e Comércio de Produtos Médicos, Odontológicos e Correlatos Sociedade Anônima
Faculdade de Odontologia de Araraquara
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must have all four bone walls after the extraction procedure; over 18 years old; who have signed the informed consent form
Exclusion criteria
Exclusion criteria: Uncontrolled systemic commitments; 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 |
|---|---|
| Evaluate the effectiveness of the Plenum® Guide polydioxone (PDO) membrane in the guided bone regeneration process through the preservation and neoformation of bone tissue in the dental alveoli after extraction procedures. Bone volume will be assessed by comparing Cone-Beam Computed Tomography (CBCT) exams obtained in the immediate postoperative period (7 days) and in the late postoperative period (3 months) for each group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondaries outcomes include the evaluation of the use of Plenum® Guide polydioxone (PDO) membrane exposed, through bone volume analysis, comparing Cone-Beam Computed Tomography (CBCT) exams obtained in the immediate postoperative period (7 days) and in the late postoperative period (3 months); and the safety of the device, which will be measured by observing adverse events. | — |
Countries
Brazil
Contacts
Public ContactThais Rojas
Outcome results
None listed