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NCT Number: NCT03667508

Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite

This study will evaluate the efficacy of rapid maxillary expansion (RME) and slow maxillary expansion (SME) in treating posterior crossbite using cone beam computed tomography.

The study sample will consist of 32 patients who suffer from a skeletal posterior crossbite. The sample will be allocated randomly into two groups: RME group and SME group.

The skeletal and dento-alveolar changes occurring after treatment will be assessed by using cone beam computed tomography(CBCT) radiographs.

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Key information

Conditions

Posterior Crossbite

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

Unilateral or bilateral posterior crossbite (PXB) is a common malocclusion. In recent decades, RME has gained preference as the treatment of choice for PXB. However, the side effects, such as reported pain, relapse of the expansion, tipping of the molars, bone loss, gingival recession, and root resorption, have lead some clinicians to prefer SME.

In this study the investigators will treat PXB using two techniques, RME and SME. Patients will be divided into two groups (a technique in each group) to evaluate the efficacy of each one using cone beam computed tomography.

RME group: A Hyrax appliance modified as McNamara will be applied. SME group: A removable appliance with central expander will be applied. In order to evaluate the changes occurring, two CBCT radiography will be taken for every individual: first, before treatment, second, after three months of retention for RME group and one month of retention for SME group

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral skeletal maxillary deficiency (symmetrical) which will be clinically and radiographically diagnosed.
  • Bilateral or unilateral functional posterior crossbite ( combined with mandibular shifting)
  • Class I or II malocclusion.
  • Normal or slight vertical growth pattern.

Exclusion criteria

  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Patients with low facial height.
  • A contraindication for rapid or slow maxillary expansion procedures.

Treatment and study plan

Rapid Maxillary Expanding Device

Procedure

The expansion screw will be turned two times in the first day, and then daily until the correction is achieved.

Other names: Bonded Acrylic Hyrax Expander

Slow Maxillary Expanding Device

Procedure

The expansion screw will be activated every five days until correcting the crossbite.

Other names: Removable Expansion Plate

Primary outcomes

  1. Change in the mandibular path of closure

    Time frame: T0: one day before the commencement of treatment; T1: after the end of active treatment and a retention period (which is expected within 14-15 weeks in the rapid expansion group and within 16-20 weeks in the slow expansion group)

    The path of the lower jaw from the rest position until closure will be clinically examined.

    The path is classified as

    • normal path of closure
    • deviated path of closure due to premature contacts

  2. Change in the anterior maxillary expansion width

    Time frame: T0: one day before the commencement of treatment; T1: after the end of active treatment and a retention period (which is expected within 14-15 weeks in the rapid expansion group and within 16-20 weeks in the slow expansion group)

    This will be assessed using cone-beam computed tomography. The anterior maxillary expansion width is measured between RPyP-LPyP (RPyP: Right piriform point. The most lateral and caudal point of the nasal piriform aperture, at the boundary with the palatal cortex. LPyP: Analogue to RPyP, left side)

  3. Change in the posterior expansion width

    Time frame: T0: one day before the commencement of treatment; T1: after the end of active treatment and a retention period (which is expected within 14-15 weeks in the rapid expansion group and within 16-20 weeks in the slow expansion group)

    This will be assessed using cone-beam computed tomography. The posterior maxillary expansion width is measured between RPaFoP and LPaFoP (RPaFoP: Right palatine foramen point. The most posterior point of the right greater palatine foramen in the maxilla within the palatal cortex. LPaFoP: Analogue to RPaFOPr, left side.)

  4. Change in the Pterygoid expansion width

    Time frame: T0: one day before the commencement of treatment; T1: after the end of active treatment and a retention period (which is expected within 14-15 weeks in the rapid expansion group and within 16-20 weeks in the slow expansion group)

    This will be assessed using cone-beam computed tomography. The Pterygoid expansion width is measured between PtR and PtL on the images. (PtR. Pterygoideous right. The most caudal point of the apex of the right pterygoid process of the sphenoid. PtL. Pterygoideous left. Analogue to PtR, left side)

  5. Change in the inter-molar width

    Time frame: T0: one day before the commencement of treatment; T1: after the end of active treatment and a retention period (which is expected within 14-15 weeks in the rapid expansion group and within 16-20 weeks in the slow expansion group)

    This will be assessed using cone-beam computed tomography. The inter-molar width is measured at molar cusps between the right and left teeth.

  6. Change in molar tipping

    Time frame: T0: one day before the commencement of treatment; T1: after the end of active treatment and a retention period (which is expected within 14-15 weeks in the rapid expansion group and within 16-20 weeks in the slow expansion group)

    This will be measured in cone-beam computed tomography images. Molar tipping is defined as the difference between (AR-AL) and (CR-CL) CR:Cuspid right which is the mesio-palatal cusp tip of the right maxillary first molar, whereas CL: Cuspid left which is the mesiopalatal cusp tip of the left maxillary first molar.

    AR: Apex right which is the apex of the palatal root of the right maxillary first molar, where as AL: Apex left which is the apex of the palatal root of the left maxillary first molar.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation the Efficacy of Rapid and Slow Maxillary Expansion in Posterior Crossbite Treatment Using Cone Beam Computed Tomography

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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