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Laser therapy in Patients with Rapids Maxillary Expansion needs

Low-level Laser therapy in Rapid Maxillary Expansion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6y979g
Enrollment
Unknown
Registered
2017-12-19
Start date
2018-01-20
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

Mouth Abnormalities

Interventions

In the maxillary expander and laser therapy group (20 patients), a Hyrax type expander will be activated and ten low-lever laser applications (two per week) with 808 nm wavelength, 100 mW power, conti
In the maxillary expander and placebo laser therapy group (20 patients), a Hyrax type expander will be activated and ten placebo laser applications (two per week) will be performed under 10 standard p
Device
Radiation
E02.594

Sponsors

Universidade Federal de Santa Maria
Lead Sponsor
Universidade Federal de Santa Maria
Collaborator

Eligibility

Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: Patients in the mixed dentition phase; maxillary atresia

Exclusion criteria

Exclusion criteria: Patients with previous orthodontic treatment history; that require other modalities of interceptive orthodontic treatment within the experimental period (10 months); systemic diseases that interfere with bone metabolism, or use medications that alter bone metabolism; craniofacial malformations; suspected or diagnosed oral cancer

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Stability of maxillary expansion on the day of stabilization of the expander screw, 3 months after screw stabilization, immediately after removal of the expander (after 6 months of containment) and 3 months after removal of the expander; verified through intercanine and intermolar distances in gypsum models in each phase through digital caliper; from the observation of a variation at least 5% in the pre and post intervention values.;Expected outcome 2: Mineral density of the palatine suture on the day of stabilization of the expander screw, 3 months after screw stabilization, immediately after removal of the expander (after 6 months of containment) and 3 months after removal of the expander; verified by measuring the optical density in the anterior region of the medial palatine suture in periapical radiographs, obtained by the parallelism technique with positioning; from the observation of a variation at least 5% in the pre and post intervention values.

Secondary

MeasureTime frame
Expected outcome 3: Dimension of the airway after 3 months of removal of the maxillary expander; verified by measuring the volume of the airways by tomography; from the observation of a variation at least 5% in the pre and post intervention values.;Expected outcome 4: Improvement in quality of life after 3 months of removal of the maxillary expander; verified by the Child Perceptions Questionnaire (B-CPQ) for children 8 to 10 years and 11 to 14 years; from the observation of at least 5% in the pre and post intervention values.;Expected outcome 5: Pain sensitivity variation on the day of stabilization of the expander screw, 3 months after screw stabilization, immediately after removal of the expander (after 6 months of containment) and 3 months after removal of the expander; verified through the visual analogue scale (VAS); from the observation of at least 5% in the pre and post intervention values.

Countries

Brazil

Contacts

Public ContactVitória Chami

Universidade Federal de Santa Maria

vchami@hotmail.com+55 (55) 99902 0352

Outcome results

None listed

Source: REBEC (via WHO ICTRP)