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Clinical Trials/NCT06009796
NCT06009796
Completed
Not Applicable

The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial

TC Erciyes University1 site in 1 country58 target enrollmentNovember 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transverse Maxillary Deficiency
Sponsor
TC Erciyes University
Enrollment
58
Locations
1
Primary Endpoint
Rhinomanometry Measurement Parameters (Pa/cm3/sn )
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance, and airway changes by applying rapid palatal expansion appliances in patients with maxillary constriction and the post-pubertal growth spurt stage.

Detailed Description

Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9 years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14, 15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Registry
clinicaltrials.gov
Start Date
November 11, 2022
End Date
July 12, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmet Yağcı

PROFESSOR

TC Erciyes University

Eligibility Criteria

Inclusion Criteria

  • With a unilateral or bilateral morphological lateral crossbite
  • Whose first molars and premolars had completely erupted at pretreatment
  • With maxillary constriction of more than 4 mm and less than 10 mm
  • Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs
  • Individuals with a body mass index of 18-24
  • Individuals with an ANB angle between 0º and 4º

Exclusion Criteria

  • craniofacial anomalies
  • compliance problems
  • systemic or genetic disease
  • previous orthodontic treatment history

Outcomes

Primary Outcomes

Rhinomanometry Measurement Parameters (Pa/cm3/sn )

Time Frame: up to 1 year

-Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.

Polygraphy Measurement Parameters (event/hour)

Time Frame: up to 1 year

- Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.

Secondary Outcomes

  • Postero-anterior Measurement Parameters(mm)(up to 1 year)
  • Model Measurement Parameters(mm)(up to 1 year)

Study Sites (1)

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