Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture

Alexandria University

Status: Enrolling

Conditions: Posterior Crossbite; Malocclusion; Maxillary Hypoplasia; Palatal Expansion Technique

Treatments: Device: MARPE; Procedure: MARPE with Corticopunctures

Study type: Interventional

Funder types: Other

Identifiers

NCT05543460

0489-8/2022

Details and patient eligibility

About

Rapid palatal expansion aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the sutures in adult patients.

The study aims to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.

Full description

Rapid palatal expansion is a common treatment modality that aims at skeletally correcting the transverse maxillary deficiency by applying forces to separate the mid-palatal suture. In adult patients, the separation of the mid-palatal suture may not be possible due to its increased interdigitation and ossification. Miniscrew-assisted rapid maxillary expansion (MARPE) was proposed to transmit the forces directly to the mid-palatal suture through palatal miniscrews in addition to the anchor teeth. However, some non-growing patients may not respond favorably to MARPE. Hence, the use of corticopunctures as an adjunct to MARPE was recently proposed to overcome the increased resistance of the ossified mid-palatal sutures in adult patients.

The aim of the study is to assess and compare the skeletal and dental effects of miniscrew-assisted rapid palatal expansion with and without corticopunctures in non-growing patients.

A randomized clinical trial will be conducted to address the aim of the study. Patients will be randomly and equally assigned to group 1 (Corticopuncture-facilitated MARPE) or group 2 (Conventional MARPE). Both groups will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea). Ten corticopunctures will be made in group 1 along the mid-palatal suture with the aid of a 3D printed surgical guide. The skeletal and dental changes will be assessed using cone beam computed tomography scans obtained before treatment and after 6 months of expansion stabilization. The results will be compared between the groups and analyzed using the appropriate statistical tests.

Enrollment: 24 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Suture maturation stage D or E according to the method of Angelieri et al. (Angelieri F, Cevidanes LH, Franchi L, Goncalves JR, Benavides E, McNamara JA, Jr. Midpalatal suture maturation: classification method for individual assessment before rapid maxillary expansion. Am J Orthod Dentofacial Orthop. 2013;144(5):759-69.)
2. Maxillary transverse deficiency measured using the method of Cantarella et al. (Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, et al. Changes in the midpalatal and pterygopalatine sutures induced by micro-implant-supported skeletal expander, analyzed with a novel 3D method based on CBCT imaging. Prog Orthod. 2017;18(1):34.)
3. Good oral hygiene (Score <2 based on the Simplified Oral Hygiene Index (OHI-S)). (Greene JC, Vermillion JR. The Simplified Oral Hygiene Index. J Am Dent Assoc. 1964;68:7-13.)

Exclusion criteria

1. History of previous orthodontic or orthopedic treatment.
2. History of facial trauma or surgery.
3. Patients with congenital craniofacial malformations or diagnosed syndromes.
4. Medical history that prohibits the surgical intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Corticopuncture-facilitated MARPE

Experimental group

Description:

Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) with corticopunctures .along the mid-palatal suture

Treatment:

Procedure: MARPE with Corticopunctures

Conventional MARPE

Active Comparator group

Description:

Patients will be treated using Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) without corticopunctures.

Treatment:

Device: MARPE