Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite

Posterior Crossbite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667508
• Other study ID #: UDDS-Ortho-19-2018
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 15, 2019
• Est. primary completion date: January 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Posterior Crossbite

Intervention

Procedure:
• Rapid Maxillary Expanding Device
The expansion screw will be turned two times in the first day, and then daily until the correction is achieved.
• Slow Maxillary Expanding Device
The expansion screw will be activated every five days until correcting the crossbite.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Orthodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View Citation

Bucci R, D'Antò 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. Review. — View Citation

Greenbaum KR, Zachrisson BU. The effect of palatal expansion therapy on the periodontal supporting tissues. Am J Orthod. 1982 Jan;81(1):12-21. — View Citation

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. — View Citation

Sandikçioglu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; normal path of closure; 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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)