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Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite

Primary Purpose

Posterior Crossbite

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Rapid Maxillary Expanding Device
Slow Maxillary Expanding Device
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Crossbite

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rapid Maxillary Expansion

Slow Maxillary Expansion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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)
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.)
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2018
Last Updated
July 16, 2019
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT03667508
Brief Title
Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite
Official Title
Evaluation the Efficacy of Rapid and Slow Maxillary Expansion in Posterior Crossbite Treatment Using Cone Beam Computed Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
January 19, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Crossbite

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid Maxillary Expansion
Arm Type
Experimental
Arm Description
Patients will undergo Rapid Maxillary Expansion using a rapid maxillary expanding device, i.e. a Hyrax expander (modified by McNamra).
Arm Title
Slow Maxillary Expansion
Arm Type
Active Comparator
Arm Description
Patients will undergo Slow Maxillary Expansion using a slow maxillary expanding device, i.e. a removable appliance with a central screw.
Intervention Type
Procedure
Intervention Name(s)
Rapid Maxillary Expanding Device
Other Intervention Name(s)
Bonded Acrylic Hyrax Expander
Intervention Description
The expansion screw will be turned two times in the first day, and then daily until the correction is achieved.
Intervention Type
Procedure
Intervention Name(s)
Slow Maxillary Expanding Device
Other Intervention Name(s)
Removable Expansion Plate
Intervention Description
The expansion screw will be activated every five days until correcting the crossbite.
Primary Outcome Measure Information:
Title
Change in the mandibular path of closure
Description
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
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)
Title
Change in the anterior maxillary expansion width
Description
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)
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)
Title
Change in the posterior expansion width
Description
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.)
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)
Title
Change in the Pterygoid expansion width
Description
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)
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)
Title
Change in the inter-molar width
Description
This will be assessed using cone-beam computed tomography. The inter-molar width is measured at molar cusps between the right and left teeth.
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)
Title
Change in molar tipping
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Rabah, DDS
Organizational Affiliation
MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22812438
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.
Results Reference
background
PubMed Identifier
6758588
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. doi: 10.1016/0002-9416(82)90283-4.
Results Reference
background
PubMed Identifier
9082855
Citation
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.
Results Reference
background
PubMed Identifier
23631965
Citation
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.
Results Reference
background
PubMed Identifier
27004835
Citation
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.
Results Reference
background

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Effectiveness of Rapid and Slow Maxillary Expansion in Treating Posterior Crossbite

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