Rapid Maxillary Expansion With Low Level Laser Therapy
Primary Purpose
Crossbite, Malocclusion, Cross Bite
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Bonded-Hyrax
Bonded Rapid Maxillary Expansion and low-Level Laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Crossbite focused on measuring bonded-Hyrax, Hyrax-expander, Maxillary constriction, Posterior cross bite, Rapid maxillary expansion
Eligibility Criteria
Inclusion Criteria:
- Posterior crossbite
- Patent mid-palatal suture
- Mixed dentition or early permanent teeth
- Subjects who reported no medical conditions or prolonged medications
Exclusion Criteria:
- Poor oral hygiene
- Active periodontal disease
- Craniofacial abnormalities
- Previous orthodontic treatment
- Any systemic disease or medication that might affect bone metabolism.
Sites / Locations
- Al-Azhar UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bonded Rapid Maxillary Expansion
Bonded Rapid Maxillary Expansion and low-Level Laser
Arm Description
Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily
Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily with 10 sessions of Indium Gallium Arsenide Phosphoride (940nm) semiconductor diode laser
Outcomes
Primary Outcome Measures
Inter-jugale width
Horizontal distance between right and left Jugale points, in millimeters.
Buccal maxillary width
Horizontal distance between the most lateral point on the right and left buccal alveolar plate at the level of the root trifurcation, in millimeters.
Bone density of the mid-palatal suture
Average density of 200mm3 volume, in hounsfield units.
Secondary Outcome Measures
Facial width
Horizontal distance between right and left zygomatico-temporal points in millimeter.
Inter-infraorbitale width
Horizontal distance between right and left infraorbitale points
Inter-lateral pterygoid width
Horizontal distance between right and left lateral pterygoid points in millimeters
Nasal width
Horizontal distance between right and left lateral nasale points in millimeters
Palatal maxillary width
Horizontal distance between the most lateral point on the right and left palatal alveolar plate at the level of the root trifurcation, in millimeters.
Buccal alveolar bone thickness at the mesiobuccal root of the first maxillary permanent molar
Horizontal distance between the most lateral point on the buccal alveolar plate opposite to the midpoint of the width of the mesiobuccal root of the upper permanent maxillary first molar at the level of the trifurcation
Buccal alveolar bone thickness at the distobuccal root of the first maxillary permanent molar
Horizontal distance between the most lateral point on the buccal alveolar plate opposite to the midpoint of the width of the distobuccal root of the upper permanent maxillary first molar at the level of the trifurcation, in millimeter.
Palatal bone thickness
Horizontal distance between the most lateral point on the right and left palatal alveolar plates at the level of the trifurcation of the upper permanent maxillary first molar.
Bi-gonial width
Horizontal distance between right and left gonion points in millimeters
Inter-mental width
Horizontal distance between right and left mental foramen in millimeters
alveolar tipping angle
Angle between the tangent to palatal alveolar bone at right and left first molar and the mid sagittal plane
Dental tipping angle
Angle between the line passing through palatal root apex and palatal cusp tip of the right and left first molar and the mid sagittal plane
Bone density of the nasal side of the Midpalatal suture
Average density in hounsfield units.
Bone density of the oral side of the Midpalatal suture
Average density in hounsfield units.
Upper airway dimension
Volume of the upper airway in mm3
Intercanine width
Distance between the right and left canine cusp tips.
Intermolar width
Distance between the right and left central fossae of the permanent maxillary first molar
Inter-first premolar width
Distance between the right and left first premolar buccal cusp tips.
Inter-second premolar width
Distance between the right and left first premolar buccal cusp tips.
Pain score
Visual Analogue Scale from 1-100. Zero denoting no pain and 100 denoting the worst pain imaginable
Day on which pain on activation stopped
The day on which the patient reports no pain with appliance activation
Full Information
NCT ID
NCT05586997
First Posted
October 16, 2022
Last Updated
October 19, 2022
Sponsor
National Research Centre, Egypt
Collaborators
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05586997
Brief Title
Rapid Maxillary Expansion With Low Level Laser Therapy
Official Title
Effect of Rapid Maxillary Expansion With Low Level Laser Therapy Versus Rapid Maxillary Expansion in Children With Posterior Cross Bite
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt
Collaborators
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The posterior crossbite is a common type of malocclusion that might affect the normal growth pattern. Early treatment is recommended by rapid maxillary expansion with different appliances. This line of treatment needs a sufficient retention period to decrease the rate of relapse. The low level laser therapy has been used to enhance tissue regeneration. This study aims to compare the effect of rapid maxillary expansion with low level laser versus rapid maxillary expansion in children with posterior cross bite malocclusions.
Detailed Description
This study aims to evaluate the effect of rapid maxillary expansion using the bonded Hyrax expander combined with low level Laser therapy versus rapid maxillary expansion alone. The investigators intend to recruit sixty subjects of both sexes, between the age of 7 and 14 years. Patients with posterior crossbites and patent Mid-palatal sutures will be randomized into one of the two groups of treatment. Full orthodontic records will be collected and the standard orthodontic radiographs will be replaced by cone beam computer tomographic images. The records will be taken before the maxillary expansion and after 6 months of retention. The skeletal, dentoalveolar, and soft tissue effects of the two interventions will be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crossbite, Malocclusion, Cross Bite, Maxillary Constriction
Keywords
bonded-Hyrax, Hyrax-expander, Maxillary constriction, Posterior cross bite, Rapid maxillary expansion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The patients will be masked by receiving sham LASER therapy in the control group. While, the outcome assessors will evaluate unidentified radiographic images and will have no knowledge of the intervention allocated.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bonded Rapid Maxillary Expansion
Arm Type
Active Comparator
Arm Description
Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily
Arm Title
Bonded Rapid Maxillary Expansion and low-Level Laser
Arm Type
Experimental
Arm Description
Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily with 10 sessions of Indium Gallium Arsenide Phosphoride (940nm) semiconductor diode laser
Intervention Type
Device
Intervention Name(s)
Bonded-Hyrax
Other Intervention Name(s)
Rapid maxillary expansion (RME)
Intervention Description
The expansion screw of the bonded-hyrax will be activated until the palatal cusps of the permanent maxillary first molars are opposing the buccal cusps of the permanent mandibular first molars
Intervention Type
Combination Product
Intervention Name(s)
Bonded Rapid Maxillary Expansion and low-Level Laser therapy
Other Intervention Name(s)
low level laser therapy (LLLT)
Intervention Description
Ten sessions of 0.5 watts for 20 seconds at 4 points along the mid-palatal suture
Primary Outcome Measure Information:
Title
Inter-jugale width
Description
Horizontal distance between right and left Jugale points, in millimeters.
Time Frame
six months of retention
Title
Buccal maxillary width
Description
Horizontal distance between the most lateral point on the right and left buccal alveolar plate at the level of the root trifurcation, in millimeters.
Time Frame
six months of retention
Title
Bone density of the mid-palatal suture
Description
Average density of 200mm3 volume, in hounsfield units.
Time Frame
six months of retention
Secondary Outcome Measure Information:
Title
Facial width
Description
Horizontal distance between right and left zygomatico-temporal points in millimeter.
Time Frame
six months of retention
Title
Inter-infraorbitale width
Description
Horizontal distance between right and left infraorbitale points
Time Frame
six months of retention
Title
Inter-lateral pterygoid width
Description
Horizontal distance between right and left lateral pterygoid points in millimeters
Time Frame
six months of retention
Title
Nasal width
Description
Horizontal distance between right and left lateral nasale points in millimeters
Time Frame
six months of retention
Title
Palatal maxillary width
Description
Horizontal distance between the most lateral point on the right and left palatal alveolar plate at the level of the root trifurcation, in millimeters.
Time Frame
six months of retention
Title
Buccal alveolar bone thickness at the mesiobuccal root of the first maxillary permanent molar
Description
Horizontal distance between the most lateral point on the buccal alveolar plate opposite to the midpoint of the width of the mesiobuccal root of the upper permanent maxillary first molar at the level of the trifurcation
Time Frame
six months of retention
Title
Buccal alveolar bone thickness at the distobuccal root of the first maxillary permanent molar
Description
Horizontal distance between the most lateral point on the buccal alveolar plate opposite to the midpoint of the width of the distobuccal root of the upper permanent maxillary first molar at the level of the trifurcation, in millimeter.
Time Frame
six months of retention
Title
Palatal bone thickness
Description
Horizontal distance between the most lateral point on the right and left palatal alveolar plates at the level of the trifurcation of the upper permanent maxillary first molar.
Time Frame
six months of retention
Title
Bi-gonial width
Description
Horizontal distance between right and left gonion points in millimeters
Time Frame
six months of retention
Title
Inter-mental width
Description
Horizontal distance between right and left mental foramen in millimeters
Time Frame
six months of retention
Title
alveolar tipping angle
Description
Angle between the tangent to palatal alveolar bone at right and left first molar and the mid sagittal plane
Time Frame
six months of retention
Title
Dental tipping angle
Description
Angle between the line passing through palatal root apex and palatal cusp tip of the right and left first molar and the mid sagittal plane
Time Frame
six months of retention
Title
Bone density of the nasal side of the Midpalatal suture
Description
Average density in hounsfield units.
Time Frame
six months of retention
Title
Bone density of the oral side of the Midpalatal suture
Description
Average density in hounsfield units.
Time Frame
six months of retention
Title
Upper airway dimension
Description
Volume of the upper airway in mm3
Time Frame
six months of retention
Title
Intercanine width
Description
Distance between the right and left canine cusp tips.
Time Frame
six months of retention
Title
Intermolar width
Description
Distance between the right and left central fossae of the permanent maxillary first molar
Time Frame
six months of retention
Title
Inter-first premolar width
Description
Distance between the right and left first premolar buccal cusp tips.
Time Frame
six months of retention
Title
Inter-second premolar width
Description
Distance between the right and left first premolar buccal cusp tips.
Time Frame
six months of retention
Title
Pain score
Description
Visual Analogue Scale from 1-100. Zero denoting no pain and 100 denoting the worst pain imaginable
Time Frame
Day 1 of appliance activation
Title
Day on which pain on activation stopped
Description
The day on which the patient reports no pain with appliance activation
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Posterior crossbite
Patent mid-palatal suture
Mixed dentition or early permanent teeth
Subjects who reported no medical conditions or prolonged medications
Exclusion Criteria:
Poor oral hygiene
Active periodontal disease
Craniofacial abnormalities
Previous orthodontic treatment
Any systemic disease or medication that might affect bone metabolism.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ElAlkamy
Phone
+20233371615
Ext
2143
Email
aminaelalkamy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam
Phone
+20233371615
Ext
2106
Email
hadeelhossam@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hend S ElSayed, PhD
Organizational Affiliation
National Research Centre, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University
City
Cairo
ZIP/Postal Code
18884
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15825776
Citation
Lagravere MO, Major PW, Flores-Mir C. Long-term dental arch changes after rapid maxillary expansion treatment: a systematic review. Angle Orthod. 2005 Mar;75(2):155-61. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
Results Reference
background
PubMed Identifier
29072861
Citation
Skondra FG, Koletsi D, Eliades T, Farmakis ETR. The Effect of Low-Level Laser Therapy on Bone Healing After Rapid Maxillary Expansion: A Systematic Review. Photomed Laser Surg. 2018 Feb;36(2):61-71. doi: 10.1089/pho.2017.4278. Epub 2017 Oct 25.
Results Reference
background
PubMed Identifier
24812743
Citation
Kang Y, Rabie AB, Wong RW. A review of laser applications in orthodontics. Int J Orthod Milwaukee. 2014 Spring;25(1):47-56.
Results Reference
background
PubMed Identifier
21803251
Citation
Baratieri C, Alves M Jr, de Souza MM, de Souza Araujo MT, Maia LC. Does rapid maxillary expansion have long-term effects on airway dimensions and breathing? Am J Orthod Dentofacial Orthop. 2011 Aug;140(2):146-56. doi: 10.1016/j.ajodo.2011.02.019.
Results Reference
background
PubMed Identifier
20381753
Citation
Molen AD. Considerations in the use of cone-beam computed tomography for buccal bone measurements. Am J Orthod Dentofacial Orthop. 2010 Apr;137(4 Suppl):S130-5. doi: 10.1016/j.ajodo.2010.01.015.
Results Reference
background
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Rapid Maxillary Expansion With Low Level Laser Therapy
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