Rapid Maxillary Expansion With Low Level Laser Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Rapid Maxillary Expansion With Low Level Laser Therapy Versus Rapid Maxillary Expansion in Children With Posterior Cross Bite

Conditions
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Crossbite, Malocclusion, Cross Bite, Maxillary Constriction

Intervention / Treatment
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* Device: Bonded-Hyrax
* Combination Product: Bonded Rapid Maxillary Expansion and low-Level Laser therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bonded Rapid Maxillary Expansion<br>Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily | Device: Bonded-Hyrax<br>* 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<br>* Other names: Rapid maxillary expansion (RME);|
| Experimental: Bonded Rapid Maxillary Expansion and low-Level Laser<br>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 | Device: Bonded-Hyrax<br>* 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<br>* Other names: Rapid maxillary expansion (RME);Combination Product: Bonded Rapid Maxillary Expansion and low-Level Laser therapy<br>* Ten sessions of 0.5 watts for 20 seconds at 4 points along the mid-palatal suture<br>* Other names: low level laser therapy (LLLT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-jugale width | Horizontal distance between right and left Jugale points, in millimeters. | six months of retention | 
| 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. | six months of retention | 
| Bone density of the mid-palatal suture | Average density of 200mm3 volume, in hounsfield units. | six months of retention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial width | Horizontal distance between right and left zygomatico-temporal points in millimeter. | six months of retention | 
| Inter-infraorbitale width | Horizontal distance between right and left infraorbitale points | six months of retention | 
| Inter-lateral pterygoid width | Horizontal distance between right and left lateral pterygoid points in millimeters | six months of retention | 
| Nasal width | Horizontal distance between right and left lateral nasale points in millimeters | six months of retention | 
| 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. | six months of retention | 
| 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 | six months of retention | 
| 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. | six months of retention | 
| 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. | six months of retention | 
| Bi-gonial width | Horizontal distance between right and left gonion points in millimeters | six months of retention | 
| Inter-mental width | Horizontal distance between right and left mental foramen in millimeters | six months of retention | 
| alveolar tipping angle | Angle between the tangent to palatal alveolar bone at right and left first molar and the mid sagittal plane | six months of retention | 
| 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 | six months of retention | 
| Bone density of the nasal side of the Midpalatal suture | Average density in hounsfield units. | six months of retention | 
| Bone density of the oral side of the Midpalatal suture | Average density in hounsfield units. | six months of retention | 
| Upper airway dimension | Volume of the upper airway in mm3 | six months of retention | 
| Intercanine width | Distance between the right and left canine cusp tips. | six months of retention | 
| Intermolar width | Distance between the right and left central fossae of the permanent maxillary first molar | six months of retention | 
| Inter-first premolar width | Distance between the right and left first premolar buccal cusp tips. | six months of retention | 
| Inter-second premolar width | Distance between the right and left first premolar buccal cusp tips. | six months of retention | 
| Pain score | Visual Analogue Scale from 1-100. Zero denoting no pain and 100 denoting the worst pain imaginable | Day 1 of appliance activation | 
| Day on which pain on activation stopped | The day on which the patient reports no pain with appliance activation | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bonded-Hyrax, Hyrax-expander, Maxillary constriction, Posterior cross bite, Rapid maxillary expansion