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Orofacial Therapy with a palatal plate in infants with Down Syndrome

Orofacial Proprioceptive Stimulation Therapy with a memory palatal plate in infants with Down Syndrome – a non-randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9bw8xtd
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-01-01
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

Down Syndrome

Interventions

This study consists of a non-randomized clinical trial, without the participation of a control group, where patients will be screened at the Dental Clinic of the Christus University Center, where they
C10.597.613.575

Sponsors

Centro universitário Christus
Lead Sponsor
Centro universitário Christus
Collaborator

Eligibility

Age
2 Months to 2 Years

Inclusion criteria

Inclusion criteria: Patients with Down Syndrome; age between 2 months and 2 years; both sexes; with Hypotonia of the facial muscles; Macroglossia; protruding flaccid tongue and insufficient lip seal; patients who are able to attend for treatment and maintenance with the memory palatal plate; patients who agree to invest in the minimum laboratory cost for the production of the memory palatal plate

Exclusion criteria

Exclusion criteria: Patients with Down Syndrome over 2 years of age

Design outcomes

Primary

MeasureTime frame
The expected outcome of the study is to promote, early on, a greater balance in the development of orofacial structures through the correct positioning of the tongue, adequate lip seal, and consequently, the improvement of hypotonia in the facial muscles through the use of a memory palatal plate; to stimulate the normalization of basic functions of sucking, swallowing, and nasal breathing for the syndromic patient, preventing future complications. Some outcome variables may include monthly attendance for monitoring and adjustment of the plate, as well as its proper use, with the expectation that, provided there is collaboration, patients will gradually improve in lip seal, hypotonia, and the development of oro facial structures

Secondary

MeasureTime frame
It is expected that children under one year old will have a better outcome with the treatment, given that most of their teeth have not yet erupted. Thus, there will be less need for adjustments during the treatment, which could compromise the fullness of the final results

Countries

Brazil

Contacts

Public ContactIsabella Fernandes Carvalho

Instituto para o Desenvolvimento da Educação Ltda-IPADE/Faculdade

draisabellacarvalho@gmail.com+55 (85) 997325781

Outcome results

None listed

Source: REBEC (via WHO ICTRP)