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Study of a Device for Bone Augmentation in maxilla

Evaluation of a New Device for Horizontal Bidirecional Bone Augmentation in maxila: a clinical and tomographic analysis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-5ydbctk
Enrollment
Unknown
Registered
2022-03-24
Start date
2019-10-10
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 resorption

Interventions

Experimental group: 10 edentulous patients with bone resorption in the jaws and requiring bone grafts for later rehabilitation with dental implants will be separated into two groups according to the c

Sponsors

Luís Guilherme Scavone de Macedo
Lead Sponsor
Faculdade São Leopoldo Mandic
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Ages between 18 and 65 years, who have bidirectional horizontal maxilla atrophy and who intend to have oral rehabilitation with the use of osseointegrated implants.

Exclusion criteria

Exclusion criteria: Pregnant, diabetics, immunocompromised patients, smokers, who are using medications that may interfere with the study results. Patients who present fracture of the bone walls during the procedure make it impossible to fix the device.

Design outcomes

Primary

MeasureTime frame
To evaluate bone formation in thickness six months after bone grafting procedure in the jaws, using computed tomography. Computed tomography scans were performed at baseline (T0) to measure bone thickness in edentulous regions and after 6 months (T1) to measure and compare values obtained after bone grafting procedure. Horizontal bone increase was observed in both studied groups, and the final volume found was 7.70 + 0.89 mm and 8.62 + 0.89 in HAC (Horizontal alveolar change) groups 3 and 4, respectively.

Secondary

MeasureTime frame
Secundary outcomes are not expected

Countries

Brazil

Contacts

Public ContactLuís Scavone de Macedo

Faculdade São Leopoldo Mandic

drluismacedo@yahoo.com.br+55-12-997444954

Outcome results

None listed

Source: REBEC (via WHO ICTRP)