Clinical Trials Logo

Clinical Trial Summary

Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.


Clinical Trial Description

Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients were randomly divided into two groups and were subsequently compared after a six month interval. The first group included 24 patients who where treated with the Bioajusta X appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. Cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic pharyngometry. The parents filled out a questionnaire with respect to the respiratory symptoms of their children. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01164631
Study type Interventional
Source University of Sao Paulo General Hospital
Contact
Status Completed
Phase Phase 4
Start date November 2006
Completion date November 2009

See also
  Status Clinical Trial Phase
Completed NCT02914431 - Personalized Titanium Plates vs CAD/CAM Surgical Splints in Maxillary Repositioning of Orthognathic Surgery N/A
Recruiting NCT05383820 - Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment Phase 4
Not yet recruiting NCT03513003 - The Use of a Pacifier to Correct Malocclusions in Young Children N/A
Completed NCT02603289 - One Week Aligner Evaluation
Terminated NCT01210547 - Three-dimensional Assessment of Craniofacial Structures N/A
Completed NCT01463839 - Sleep Disorder and Oral Habits in Children N/A
Recruiting NCT04946201 - Premolar Extractions for Obstructive Sleep Apnea in Children With Overjet
Recruiting NCT04117360 - Orthognathic Speech Pathology: Phonetic Contrasts of Patients With Dental Discrepancies Pre- and Post-Treatment Analyses
Active, not recruiting NCT06291129 - Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents N/A
Recruiting NCT05684510 - Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy N/A
Completed NCT02659813 - Orthodontic Archwire Effectiveness Trial N/A
Completed NCT02427763 - Microbiological and Epithelial Evaluation Related to the Use of Orthodontic Thermoplastic Device Phase 0
Completed NCT01962012 - Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners Phase 4
Completed NCT02267811 - The Effect of OrthoPulseā„¢ on the Rate of Orthodontic Tooth Movement N/A
Completed NCT03405961 - A Comparison of Conventional Versus Digital PAR (Peer Assessment Rating) Scores Using an Intraoral Scanner
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Recruiting NCT06218641 - Discomfort Perceived by a Cohort of Patients Treated With Aligners and Attachments Placed According to Two Different Protocols N/A
Completed NCT05711160 - Comparison of the Accuracy and Reliability of Measurements Made on CBCT and IOS Images With Their made-on Plaster Models.
Recruiting NCT06140043 - Augmented Reality for Orthognatic Surgery Patient Education Phase 2/Phase 3
Recruiting NCT05573308 - Optimizing Orthodontic Appliances Efficiency With Remote Dental Monitoring and Artificial Intelligence Algorithms N/A