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Split-mouth randomized clinical trial to compare ceramic and autogenous bone grafts.

Use of 3D ceramic block graft compared to autogenous block graft for bone augmentation of atrophic maxilla. Split-mouth randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-76wmm3q
Enrollment
Unknown
Registered
2021-09-14
Start date
2022-03-01
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 ridge atrofy without teeth

Interventions

• Tomography (20 participants, 60 total scans): All participants must undergo a cone beam computed tomography (CBCT) exam. The exams will be requested prior to installation of bone grafts (T1), remova
8mA
0.125mm Voxel and 18s Full Spin. • Preparation and installation of autogenous graft (control group, 20 participants, split-mouth study): The 20 recruited participants will initially receive extra and

Sponsors

M3 Health Ind. Com. de Prod. Méd., Odont. e Correlatos SA.
Lead Sponsor
Faculdade de Odontologia de Araraquara (FOAr/UNESP)
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Bone insufficiency in the anterior region, with a minimum height of 7mm and width less than or equal to 5mm evaluated by cone beam computed tomography; Over 18 years old; who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: Patients who present general contraindications to the surgical procedure;Patientes submitted to radiation in the head and neck region; Patients with immunosuppression or immunosuppression; Patients treated or undergoing treatment with anti-resorptive drugs or that alter bone metabolism; Patients with untreated periodontal disease;Patients with poor oral hygiene; Pregnant and lactating women; Uncontrolled diabetic patients; Patients with psychiatric problems or unrealistic expectations; Smokers.

Design outcomes

Primary

MeasureTime frame
Evaluate the gain in the increase/maintenance of the volume of the bone graft area and the quality of the newly formed bone tissue, by comparing tomographies performed after graft installation (T2) and after 8 months of repair (T3). The volume maintenance increase will be defined by calculating the difference in the area of T3-T2 in millimeters.

Secondary

MeasureTime frame
Evaluate bone neoformation in the anterior region of the maxilla by evaluating the percentage of newly formed bone tissue, percentage of soft tissue and percentage of residual material from the bone graft. The biopsy will be obtained 8 months after the installation of the bone grafts.;Check whether the bone graft (customized or autogenous in block) can interfere with the primary and secondary stability of the implants installed in the region. Primary and secondary stability will be measured using Osstell® Resonance Frequency Analysis (RFA) (Osstell AB, Göteborg, Sweden). Primary Stability: Right after implant placement (8 months after graft placement). Secondary stability: 6 months after implant placement (14 months after graft placement). Values will be obtained in torque (Ncm-1).;Evaluate the maturation of the newly formed bone tissue through the quantification of osteocalcin (OCN). The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the bone metabolism marker antibody osteocalcin. This test will be carried out 8 months after the installation of bone grafts. The evaluation will be done by quantifying the expression of OCN, measured by the number of colored nucleus.;Evaluate the differentiation activity of osteoblastic cells by quantifying the morphogenetic protein -2 (BMP-2). The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the bone metabolism marker antibody Bone Morphogenetic Protein 2 (BMP-2), 8 months after the installation of the bone grafts. The evaluation will be done by quantifying the expression of BMP-2, measured by the number of colored nucleus.;Evaluate the production of collagen matrix through the quantification of alkaline phosphatase. The indirect immunoperoxidase technique with amplifier will be used to prepare the histological slide for binding with the bone metabolism marker antibody alkaline phosphatase, 8 mont

Countries

Brazil

Contacts

Public ContactElcio Marcantonio Junior
elcio.marcantonio@unesp.br+55-016-33016378

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 11, 2026