ClinicalTrials.Veeva

Menu

The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance

T

TC Erciyes University

Status

Completed

Conditions

Transverse Maxillary Deficiency

Treatments

Device: Tooth Tissue Borne Rapid Palatal Expansion
Device: Tooth Bone Borne Rapid Palatal Expansion

Study type

Interventional

Funder types

Other

Identifiers

NCT06009796
TDH-2022-12101

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

14 to 17 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 4 patient groups

Full Coverage Rapid Palatal Expansion (FCRPE) group:
Active Comparator group
Description:
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.
Treatment:
Device: Tooth Tissue Borne Rapid Palatal Expansion
Modified McNamara Rapid Palatal Expansion (MMRPE) Group:
Active Comparator group
Description:
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.
Treatment:
Device: Tooth Tissue Borne Rapid Palatal Expansion
Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group
Active Comparator group
Description:
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.
Treatment:
Device: Tooth Bone Borne Rapid Palatal Expansion
Control Group
No Intervention group
Description:
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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems