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Rapid Maxillary Expansion for Residual Pediatric

NCT02947464 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-08-20

No results posted yet for this study

Summary

Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.

Conditions

Interventions

PROCEDURE

Standard clinical practice

Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.

DEVICE

Standard clinical practice + Rapid Maxillary Expansion

Mid-palatal suture osteogenic distraction delivered through a self-activated acrylic intraoral device custom-fit into the children´s palate and maxillary posterior teeth providing a transverse expansion of the dentofacial skeleton.

Sponsors & Collaborators

  • Basque Health Service

    lead OTHER_GOV

Principal Investigators

  • Marcos Fernández-Barriales · Basque Health Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2021-05-30
Completion
2021-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947464 on ClinicalTrials.gov