Miniscrew-assisted Rapid Palatal Expansion With and Without Corticopuncture

NCT05543460 | Completed

• 1 other identifier: 0489-8/2022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Palatal Expansion Technique; Posterior Crossbite; Maxillary Hypoplasia; Malocclusion

Keywords

Rapid palatal expansion; Maxillary Skeletal Expander; Corticopunctures; MARPE

Outcome Measures

Primary Outcomes (1)

• Transverse skeletal changes from baseline to an average of 6 months after the initial activation, measured using cone beam computed tomography (CBCT)

  The data from CBCT scans at the different time points will be exported in Digital Imaging and Communications in Medicine (DICOM) format and processed using suitable software. The relevant landmarks will be defined and located by the investigator to measure the transverse skeletal changes in mm from baseline to the end of passive retention of the expansion.

  At baseline and an average of 6 months after the initial activation

Secondary Outcomes (1)

• Dento-alveolar inclination changes from baseline to an average of 6 months after the initial activation, measured using CBCT

  At baseline and an average of 6 months after the initial activation

Study Arms (2)

Corticopuncture-facilitated MARPE

EXPERIMENTAL

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

Procedure: MARPE with Corticopunctures

Conventional MARPE

ACTIVE COMPARATOR

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

Device: MARPE

Interventions

MARPE with Corticopunctures PROCEDURE

Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency aided with corticopunctures made along the mid-palatal suture

Corticopuncture-facilitated MARPE

MARPE DEVICE

Maxillary Skeletal Expander (MSE II, Biomaterials Korea Inc., Seoul, Korea) used to correct the maxillary transverse deficiency

Conventional MARPE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• 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.)
• 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.)

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Related Publications (5)

• Zeuke W, Heidrich R. [Late paralysis of the peripheral nerves from the neurologic viewpoint]. Zentralbl Neurochir. 1983;44(1):53-5. German.

  PMID: 6305058 BACKGROUND

• Bud ES, Bica CI, Pacurar M, Vaida P, Vlasa A, Martha K, Bud A. Observational Study Regarding Possible Side Effects of Miniscrew-Assisted Rapid Palatal Expander (MARPE) with or without the Use of Corticopuncture Therapy. Biology (Basel). 2021 Mar 3;10(3):187. doi: 10.3390/biology10030187.

  PMID: 33802266 BACKGROUND

• 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 Nov;144(5):759-69. doi: 10.1016/j.ajodo.2013.04.022.

  PMID: 24182592 BACKGROUND

• Cantarella D, Dominguez-Mompell R, Mallya SM, Moschik C, Pan HC, Miller J, Moon W. 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 Nov 1;18(1):34. doi: 10.1186/s40510-017-0188-7.

  PMID: 29090368 BACKGROUND

• GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

  PMID: 14076341 BACKGROUND

MeSH Terms

Conditions

Retrognathia; Malocclusion

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Diseases

Study Officials

• Yomna M Yacout, MSc, PhD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Eiman S Marzouk, MSc, PhD

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: August 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: March 1, 2024
• Last Updated: October 2, 2025

Record last verified: 2022-09

Locations

EG (1)