Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite

NCT03667508 | Completed DMC

• 1 other identifier: UDDS-Ortho-19-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posterior Crossbite

Outcome Measures

Primary Outcomes (6)

• Change in the mandibular path of closure

  The path of the lower jaw from the rest position until closure will be clinically examined. The path is classified as 1. normal path of closure 2. deviated path of closure due to premature contacts

  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)

• Change in the anterior maxillary expansion width

  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)

  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)

• Change in the posterior expansion width

  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.)

  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)

• Change in the Pterygoid expansion width

  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)

  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)

• Change in the inter-molar width

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

  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)

• Change in molar tipping

  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.

  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)

Study Arms (2)

Rapid Maxillary Expansion

EXPERIMENTAL

Patients will undergo Rapid Maxillary Expansion using a rapid maxillary expanding device, i.e. a Hyrax expander (modified by McNamra).

Procedure: Rapid Maxillary Expanding Device

Slow Maxillary Expansion

ACTIVE COMPARATOR

Patients will undergo Slow Maxillary Expansion using a slow maxillary expanding device, i.e. a removable appliance with a central screw.

Procedure: Slow Maxillary Expanding Device

Interventions

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.

Also known as: Bonded Acrylic Hyrax Expander

Rapid Maxillary Expansion

Slow Maxillary Expanding Device PROCEDURE

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

Also known as: Removable Expansion Plate

Slow Maxillary Expansion

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

Location

Related Publications (6)

• Martina R, Cioffi I, Farella M, Leone P, Manzo P, Matarese G, Portelli M, Nucera R, Cordasco G. Transverse changes determined by rapid and slow maxillary expansion--a low-dose CT-based randomized controlled trial. Orthod Craniofac Res. 2012 Aug;15(3):159-68. doi: 10.1111/j.1601-6343.2012.01543.x. Epub 2012 Mar 27.

  PMID: 22812438 BACKGROUND

• Greenbaum KR, Zachrisson BU. The effect of palatal expansion therapy on the periodontal supporting tissues. Am J Orthod. 1982 Jan;81(1):12-21. doi: 10.1016/0002-9416(82)90283-4.

  PMID: 6758588 BACKGROUND

• Sandikcioglu M, Hazar S. Skeletal and dental changes after maxillary expansion in the mixed dentition. Am J Orthod Dentofacial Orthop. 1997 Mar;111(3):321-7. doi: 10.1016/s0889-5406(97)70191-4.

  PMID: 9082855 BACKGROUND

• Brunetto M, Andriani Jda S, Ribeiro GL, Locks A, Correa M, Correa LR. Three-dimensional assessment of buccal alveolar bone after rapid and slow maxillary expansion: a clinical trial study. Am J Orthod Dentofacial Orthop. 2013 May;143(5):633-44. doi: 10.1016/j.ajodo.2012.12.008.

  PMID: 23631965 BACKGROUND

• Bucci R, D'Anto V, Rongo R, Valletta R, Martina R, Michelotti A. Dental and skeletal effects of palatal expansion techniques: a systematic review of the current evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2016 Jul;43(7):543-64. doi: 10.1111/joor.12393. Epub 2016 Mar 23.

  PMID: 27004835 BACKGROUND

• Rabah N, Al-Ibrahim HM, Hajeer MY, Ajaj MA. Evaluation of rapid versus slow maxillary expansion in early adolescent patients with skeletal maxillary constriction using cone-beam computed tomography: A short-term follow-up randomized controlled trial. Dent Med Probl. 2022 Oct-Dec;59(4):583-591. doi: 10.17219/dmp/133513.

  PMID: 36108265 DERIVED

Study Officials

• Nancy Rabah, DDS

  MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

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: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: March 19, 2018
• Primary Completion: January 19, 2019
• Study Completion: June 15, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)