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Completed

NCT Number: NCT06009796

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

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.

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, 38000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tooth Tissue Borne Rapid Palatal Expansion

Device

In all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.

Tooth Bone Borne Rapid Palatal Expansion

Device

After the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.

Primary outcomes

  1. 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.

  2. 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

  1. Postero-anterior Measurement Parameters(mm)

    Time frame: up to 1 year

    • NCB-NCB': Distance between right and left nasal cavity borders(mm)
    • JP-JP' : Distance between right and left jugal processes(mm)
    • AGP-AGP' : Distance between right and left antagonial points(mm)
  2. Model Measurement Parameters(mm)

    Time frame: up to 1 year

    • C-C : Distance between cusp crests of canines(mm)
    • C'-C' : Distance between cingulum of canines(mm)
    • M1-M1 : The distance between buccal tubercles of first molar(mm)
    • M1'-M1' : The distance between the lingual tubercles of first molar(mm)

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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