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Bone regeneration with absorbable membrane after tooth extraction

Guided regeneration with Polydioxanone (PDO) membrane in dental alveoli after tooth extraction: clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7322n6s
Enrollment
Unknown
Registered
2025-04-04
Start date
2024-12-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guided Tissue Regeneration

Interventions

The intervention of the study will be conducted on 65 dental sockets of adult patients requiring extraction of posterior mandibular teeth for subsequent rehabilitation with dental implants, which will

Sponsors

Universidade Estadual Paulista Julio de Mesquita Filho
Lead Sponsor
Faculdade de Odontologia da Universidade Estadual Paulista Julio de Mesquita Filho - Campus Araraquara
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Have all four bony walls after the extraction procedure; over 18 years old; both genders; have signed the Free and Informed Consent Form

Exclusion criteria

Exclusion criteria: Uncontrolled systemic involvement; teeth in areas of tumor lesions; acute infectious processes; deciduous teeth; untreated periodontal problems; smokers; irradiated in the head or neck region; allergy to any component used in the research; psychological disorders; pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Preservation of alveolar bone volume after tooth extraction, evaluated through the comparison of cone-beam computed tomography scans performed preoperatively, immediately postoperatively up to seven days after extraction, and at a late postoperative period after three months, with bone volume calculated using three-dimensional segmentation software to determine whether the use of the absorbable membrane Plenum Guide, either exposed or covered by gingival tissue, promotes greater maintenance of alveolar bone volume compared to the control group without a membrane and to the groups treated with the synthetic bone graft Plenum Osshp, with or without the association of the absorbable membrane Plenum Guide, either exposed or covered by gingival tissue, with the difference in bone volume between periods used to determine the effectiveness of each intervention in bone preservation before dental implant placement

Secondary

MeasureTime frame
Evaluation of bone neoformation, connective tissue, and remaining synthetic graft through histomorphometric and immunohistochemical analysis performed on biopsies collected at the time of dental implant placement, evaluation of the primary stability of dental implants through resonance frequency analysis using the Osstell device, as well as evaluation of the safety of the absorbable membrane Plenum Guide and the different investigated treatments by recording adverse events such as persistent pain, exacerbated edema, infection, and surgical wound dehiscence throughout the patient follow-up period

Countries

Brazil

Contacts

Public ContactEduardo Vieira

Faculdade de Odontologia da Universidade Estadual Paulista Julio de Mesquita Filho - Campus Araraquara

eduardo.hochuli@unesp.br+55 (16) 981246162

Outcome results

None listed

Source: REBEC (via WHO ICTRP)