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Outcomes of Alveolar Bone Grafting performed with chin or iliac crest associated with Platelet-rich Fibrin in patients with Complete Unilateral Cleft Lip and Palate

Result of Alveolar Bone Grafts from chin or iliac crest associated with Platelet Rich Fibrin in patients with CLPUC

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-24rgf7n
Enrollment
Unknown
Registered
2025-05-13
Start date
2023-12-11
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

Cleft palate

Interventions

This randomized clinical trial will evaluate the outcomes of alveolar bone grafts (ABGs) in patients with complete unilateral cleft lip and palate (CUCLP) using autogenous bone from the mandibular sym
E02.095.147.725.052
A12.207.152.693.600.500

Sponsors

Hospital de Reabilitação de Anomalias Craniofaciais, Universidade de São Paulo
Lead Sponsor
Hospital de Reabilitação de Anomalias Craniofaciais, Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Alveolar bone grafting surgery performed by a single surgeon and using the mandibular symphysis or iliac crest as a donor area, associated or not with Platelet-Rich Fibrin (PRF); having Complete Unilateral Cleft Lip and Palate (CUCLP); without distinction of sex; without distinction age

Exclusion criteria

Exclusion criteria: Presence of associated craniofacial syndromes and comorbidities, as well as diseases or use of medications that may influence the preparation of the Platelet-Rich Fibrin (PRF)

Design outcomes

Primary

MeasureTime frame
It is expected to observe a greater alveolar bone fill after 12 months, verified through cone beam computed tomography (CBCT), using ITK-Snap and 3D Slicer software for three-dimensional volumetric measurement of the alveolar cleft defect before and after surgery The outcome will be quantified by the percentage of new bone formation, calculated using the formula (Vf-Vdd)/Vf, where Vf represents the preoperative cleft volume and Vdd the volume of the non-mineralized area after 12 months Bone formation greater than 75% will be considered satisfactory—

Secondary

MeasureTime frame
To evaluate the quality of bone repair at the mandibular symphysis donor site, verified through CBCT and volumetric segmentation using ITK-Snap and 3D Slicer software, measuring bone regeneration volume at the donor site 12 months postoperatively A recovery greater than 75% of the harvested volume will be considered satisfactory—

Countries

Brazil

Contacts

Public ContactBruno Braga

Hospital de Reabilitação de Anomalias Craniofaciais, Universidade de São Paulo

brunomrbraga@usp.br+55 (14) 3235-8084

Outcome results

None listed

Source: REBEC (via WHO ICTRP)