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

NCT ID: NCT06009796

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2023-07-12

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.

Conditions

Transverse Maxillary Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Full Coverage Rapid Palatal Expansion (FCRPE) group:

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.

Group Type: ACTIVE_COMPARATOR

Tooth Tissue Borne Rapid Palatal Expansion

Intervention Type: 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.

Modified McNamara Rapid Palatal Expansion (MMRPE) Group:

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.

Group Type: ACTIVE_COMPARATOR

Tooth Tissue Borne Rapid Palatal Expansion

Intervention Type: 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.

Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group

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.

Group Type: ACTIVE_COMPARATOR

Tooth Bone Borne Rapid Palatal Expansion

Intervention Type: 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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tooth Tissue Borne Rapid Palatal Expansion

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.

Intervention Type: DEVICE

Tooth Bone Borne Rapid Palatal Expansion

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Yağcı

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet YAGCI, PROFESSOR

Role: STUDY_DIRECTOR

Erciyes University Faculty of Dentistry

Locations

Erciyes University Faculty of Dentistry ,Department of Orthodontics

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 15782523 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20685540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21683264 (View on PubMed)

Other Identifiers

TDH-2022-12101

Identifier Type: -

Identifier Source: org_study_id