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Evaluation of maxilla, mandible and nose size among participants with Cleft Lip compared to participants without Cleft Lip

Evaluation of the maxillomandibular and nasal proportion of participants with Cleft Lip and Palate compared to normotypical participants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-38trvv9
Enrollment
Unknown
Registered
2023-09-26
Start date
2023-10-20
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 prospective longitudinal clinical study, qualitative and quantitative, in vivo. A convenience sample will be selected from a total of 100 newborn babies, of both genders, divided into 5 grou
E02.760.731.775.500

Sponsors

Faculdade de Odontologia da Universidade Federal de Minas Gerais
Lead Sponsor
Hospital da Baleia
Collaborator

Eligibility

Age
No minimum to 1 Months

Inclusion criteria

Inclusion criteria: Non-syndromic individuals with unilateral or bilateral cleft lip and palate; individuals born up to 3 weeks old (control and to be treated with NAM); individuals aged up to 2 years (groups not treated with NAM – pre and post surgical follow-up); male and female babies individuals with no cleft lip and palate (control group); individuals without a medical history of recurrent middle ear otitis; individuals whose parents and/or guardians agree to participate in the study and sign the TCLE; individuals whose parents or guardians are of legal age

Exclusion criteria

Exclusion criteria: Cleft individuals with other systemic diseases; participants with incomplete cleft lip and palate; individuals who have already undergone palate repair surgery; individuals using topical or systemic antibiotics or corticosteroids, individuals whose parents or guardians are minors

Design outcomes

Primary

MeasureTime frame
Analyzing the maxillomandibular and nasal growth of participants with Cleft Lip and Palate, through measurements in the first month of life, pre and post surgery for babies with cleft lip and palate and at 6 months for nomotypic babies

Secondary

MeasureTime frame
Compare the proteins associated with maxillary bone remodeling of normotypic babies with Cleft Lip babies

Countries

Brazil

Contacts

Public ContactJosé Dilson Júnior

Faculdade de Odontologia da Universidade Federal de Minas Gerais

doutordilsonjunior@gmail.com+55(098)984740126

Outcome results

None listed

Source: REBEC (via WHO ICTRP)