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

NCT06009796 | Completed

• 1 other identifier: TDH-2022-12101
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Transverse Maxillary Deficiency

Keywords

Maxillary expansion; Respiratory polygraphy; Rhinomanometry; MARPE

Outcome Measures

Primary Outcomes (2)

• Rhinomanometry Measurement Parameters (Pa/cm3/sn )

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

  up to 1 year

• Polygraphy Measurement Parameters (event/hour)

  \- 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.

  up to 1 year

Secondary Outcomes (2)

• Postero-anterior Measurement Parameters(mm)

  up to 1 year

• Model Measurement Parameters(mm)

  up to 1 year

Study Arms (4)

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.

Device: Tooth Tissue Borne Rapid Palatal Expansion

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.

Device: Tooth Tissue Borne Rapid Palatal Expansion

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.

Device: Tooth Bone Borne Rapid Palatal Expansion

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.

Interventions

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.

Full Coverage Rapid Palatal Expansion (FCRPE) group:; Modified McNamara Rapid Palatal Expansion (MMRPE) Group:

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.

Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, 38000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15782523 BACKGROUND

• 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.

  PMID: 20685540 BACKGROUND

• 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.

  PMID: 21683264 BACKGROUND

Study Officials

• Ahmet YAGCI, PROFESSOR

  Erciyes University Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 24, 2023
• Study Start: November 11, 2022
• Primary Completion: March 14, 2023
• Study Completion: July 12, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)