Clinical trial NCT06009796: The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance
Official title: The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transverse Maxillary Deficiency
Keywords: Maxillary expansion
Respiratory polygraphy
Rhinomanometry
MARPE
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 58
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty eight patients were divided into 4 groups: FCRPE group (n: 15, 15.6 ± 1,1 years of age), MMRPE group (n:14, 15.3 ± 0,9 years of age), MARPE group (n:14, 15.7 ± 1,1 years of age), Control group (n:15, 15.4 ± 1,0 years of age). 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rhinomanometry Measurement Parameters (Pa/cm3/sn )
timeFrame: up to 1 year
measure: Polygraphy Measurement Parameters (event/hour)
timeFrame: up to 1 year
Secondary outcomes:
measure: Postero-anterior Measurement Parameters(mm)
timeFrame: up to 1 year
measure: Model Measurement Parameters(mm)
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Dentistry ,Department of Orthodontics
Study officials:
affiliation: Erciyes University Faculty of Dentistry
name: Ahmet YAGCI, PROFESSOR
role: STUDY_DIRECTOR
References:
citation: Lagravere MO, Major PW, Flores-Mir C. Skeletal and dental changes with fixed slow maxillary expansion treatment: a systematic review. J Am Dent Assoc. 2005 Feb;136(2):194-9. doi: 10.14219/jada.archive.2005.0141.
citation: Lee KJ, Park YC, Park JY, Hwang WS. Miniscrew-assisted nonsurgical palatal expansion before orthognathic surgery for a patient with severe mandibular prognathism. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):830-9. doi: 10.1016/j.ajodo.2007.10.065.
citation: Seeberger R, Kater W, Schulte-Geers M, Davids R, Freier K, Thiele O. Changes after surgically-assisted maxillary expansion (SARME) to the dentoalveolar, palatal and nasal structures by using tooth-borne distraction devices. Br J Oral Maxillofac Surg. 2011 Jul;49(5):381-5. doi: 10.1016/j.bjoms.2010.05.015. Epub 2010 Jun 17.