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Study of Micrografting with a device for bone augmentation

Use of bone and periosteal micrograft, associated to the xenograft, in vertical bone reconstruction with Barbell Technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-62kckb2
Enrollment
Unknown
Registered
2024-03-15
Start date
2021-06-07
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

Alveolar Bone Loss

Interventions

This is a 3-arm, double-blind, randomized clinical study. Sites requiring both inlay and onlay reconstruction were enrolled in the study. In Control Group (CG, n=8), an anorganic xenograft was used in

Sponsors

Centro de Pesquisas Odontológicas São Leopoldo Mandic SS
Lead Sponsor
Centro de Pesquisas Odontológicas São Leopoldo Mandic SS
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients of both genders; partially edentulous for more than 1 year; with absence of two teeth at least and at most five at the posterior maxilla (unilateral or bilateral); requiring implants in the posterior maxillary region with no more than 4 mm of remaining alveolar ridge; with need for maxillary sinus floor augmentation combined with onlay vertical bone augmentation in one or both sides; all patients should have between 18 and 65 years of age, with adequate oral health

Exclusion criteria

Exclusion criteria: Patients with a history of neoplastic disease treated with radiotherapy or chemotherapy; pregnant or breastfeeding; receiving treatment or affected by an illness that could influence on bone homeostasis; sinus pathologies; smokers; alcoholics; drug addicts

Design outcomes

Primary

MeasureTime frame
Expected outcome 1. It's expected to find absence of differences in the percentage of bone regenerated level (vital mineralized tissue - VMT), verified by histomorphometric analysis, using a comparative statistical analysis, for both inlay and inlay augmentations;Discovered outcome 1. It was verified a lower percentage (statistically significant) of newly formed bone (vital mineralized tissue - VMT), for onlay augmentations, in the test group 2 (TG2), in comparison with control (CG) and test 1 (TG1) groups, by using the histomorphometric analysis. For inlay augmentations, no difference was observed between groups

Secondary

MeasureTime frame
Expected outcome 2. It is expected to verify absence of statistical differences in bone volume between groups, measured by cone beam computed tomography, performed before and 6 months after grafting;Discovered outcome 2. It was verified absence of bone volume differences between groups, measured by cone beam computed tomography, performed before and 6 months after grafting

Countries

Brazil

Contacts

Public ContactAndré Pelegrine

Faculdade São Leopoldo Mandic

pelegrineandre@gmail.com+55-19-981737532

Outcome results

None listed

Source: REBEC (via WHO ICTRP)