Skip to content

Direct Tracks to correct Unilateral Crossbite in children

Planas Direct Tracks (PDT) compared with no intervention for correction of Functional Posterior Crossbites in children: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7w2yvfp
Enrollment
Unknown
Registered
2025-01-16
Start date
2025-02-17
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

Crossbite

Interventions

This is a randomized clinical trial on the treatment of unilateral posterior crossbite. Forty children who meet the inclusion criteria will be recruited consecutively over a period of one month. The c

Sponsors

Associação Brasileira de Odontologia secção Bahia
Lead Sponsor
Associação Brasileira de Odontologia secção Bahia
Collaborator
Universidade de Sorocaba
Collaborator

Eligibility

Age
4 Years to 5 Years

Inclusion criteria

Inclusion criteria: Children between 4-5 years of age, both sexes; who have Posterior Crossbites Functional; and do not yet have the first permanent molar erupted; posterior unilateral crossbite defined as minimum two crossed posterior teeth; deviation of mandibular position from contact in centric occlusion to position of maximum intercuspation accompanied by line deviation average of at least 1mm; perimeter compatibility between the arches, that is, in position centric relationship, the maxilla should not exceed the mandible by more than 2mm; children who have eliminated finger-sucking and/or pacifier habits due to fur least 6 months until the exam date; children whose parents sign an informed consent form after the carrying out the exams

Exclusion criteria

Exclusion criteria: Children with cleft lip and/or palate; syndromes or neurological diseases associated with craniofacial anomalies or dental ankylosis; children with anterior crossbite or class III skeletal relationship; previous orthodontic treatment; caries or extensive restorations, with mesio-distal or disto-vestibular involvement

Design outcomes

Primary

MeasureTime frame
Correction of posterior crossbite measured clinically in maximum intercuspation and on scanned models. The primary outcome will be assessed clinically immediately after the intervention and again after 12 months of follow-up

Secondary

MeasureTime frame
Stability of the crossbite correction, measured by clinical examination one year after the completion of the Planas Direct Tracks;Correction of the mandibular position deviation, measured by the midline correction in a clinical examination immediately after and one year after the completion of the Planas Direct Tracks. A difference of 1 mm or more will be considered a deviation;Sagittal and transversal maxillary growth measured in the scanned models. A difference of 1 mm or more will be considered significant;Treatment time defined by number of sessions;Number of complications (sessions - resin breaks, pain or discomfort);Cost of treatment, measured by chair hours or clinical visits (procedures + resin replacements or occlusal adjustments) and cost of materials used (adhesive system, resins, cotton, carbon);Normal or adapted swallowing; preferred chewing side: right, left or both. Measured by a speech therapist at the beginning and after 1 year of follow-up;Respiratory disorder – patient has positive screening for respiratory disorders or not – measured by an specialist at the beginning and after 12 months of follow-up;Vertical dimensions: static and dynamic (AFMPs) – measured by 2 researchers, through photogrammetry, at the beginning, after intervention and 1 year after follow-up. Cut-off point 1 degree for the dynamic measurement of Planas Masticatory Functional Angle. And, for the static measurement of the right and left vertical dimensions, the cut-off point will be 1 millimeter

Countries

Brazil

Contacts

Public ContactMaria Rita Xavier

Associação Brasileira de Odontologia secção Bahia

mrsancho560@gmail.com+55 (71) 22034055

Outcome results

None listed

Source: REBEC (via WHO ICTRP)