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Clinical Trials/NCT06009796
NCT06009796CompletedNot 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 enrollmentStarted: November 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
1
Primary Endpoint
Rhinomanometry Measurement Parameters (Pa/cm3/sn )

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Full Coverage Rapid Palatal Expansion (FCRPE) group:

Active Comparator

Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of all maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.

Intervention: Tooth Tissue Borne Rapid Palatal Expansion (Device)

Modified McNamara Rapid Palatal Expansion (MMRPE) Group:

Active Comparator

Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of the posterior maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.

Intervention: Tooth Tissue Borne Rapid Palatal Expansion (Device)

Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group

Active Comparator

The MARPE appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone.

Intervention: Tooth Bone Borne Rapid Palatal Expansion (Device)

Control Group

No Intervention

A control group in the same age, without maxillary constriction was also added to our study.Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance were used. Polygraphy and rhinomanometry measurements were obtained at the beginning of the follow-up and at the end of the 4-month follow-up period.

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmet Yağcı

PROFESSOR

TC Erciyes University

Study Sites (1)

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