Skip to content

The use of Fat Components to improve Bone Grafting in patients with Tertiary Alveolar Cleft: a prospective, randomized and controlled study

Non-enzymatic Stromal Vascular Fraction used to enhance Bone Grafting in Tertiary Alveolar Cleft patients: a prospective, randomized and controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-103pw9q3
Enrollment
Unknown
Registered
2024-03-14
Start date
2020-07-23
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 is a two-arm, randomized, controlled, prospective clinical study. The participants will be randomized into 2 main groups of 15 participants. The control group (group A) will be treated with iliac
BA …). Patients without a fat donor area will necessarily be allocated to the control group.

Sponsors

Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Alveolar cleft; Permanent dentition; No other comorbidities

Exclusion criteria

Exclusion criteria: Bilateral alveolar cleft Primary or secondary alveolar bone graft; Orthodontic treatment less than 2 months before the surgery; Orthodontic movement before 6 months postoperatively; Bad oral hygiene; Other comorbidities and syndromic patients; Disagreement with methodology

Design outcomes

Primary

MeasureTime frame
It is expected to evaluate the formation of alveolar bone in cm³, verified by the method of computed tomography and comparative 3D (three-dimensional) reconstruction of the preoperative and postoperative. It is expected to find a higher rate of bone formation in the intervention group, compared to the control group.

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactKleber Kurimori

Hospital da Clinicas da Faculdade de Medicina da Universidade de São Paulo

kleber.kurimori@usp.br+5511975415884

Outcome results

None listed

Source: REBEC (via WHO ICTRP)