Crossbite, Cross Bite, Malocclusion, Maxillary Constriction
Conditions
Keywords
bonded-Hyrax, Hyrax-expander, Maxillary constriction, Posterior cross bite, Rapid maxillary expansion
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.
Interventions
DEVICEBonded-Hyrax
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
COMBINATION_PRODUCTBonded Rapid Maxillary Expansion and low-Level Laser therapy
Ten sessions of 0.5 watts for 20 seconds at 4 points along the mid-palatal suture
Sponsors
Al-Azhar University
National Research Centre, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Posterior crossbite 2. Patent mid-palatal suture 3. Mixed dentition or early permanent teeth 4. Subjects who reported no medical conditions or prolonged medications
Exclusion criteria
1. Poor oral hygiene 2. Active periodontal disease 3. Craniofacial abnormalities 4. Previous orthodontic treatment 5. Any systemic disease or medication that might affect bone metabolism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-jugale width | six months of retention | Horizontal distance between right and left Jugale points, in millimeters. |
| Buccal maxillary width | six months of retention | 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 | six months of retention | Average density of 200mm3 volume, in hounsfield units. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal width | six months of retention | Horizontal distance between right and left lateral nasale points in millimeters |
| Palatal maxillary width | six months of retention | 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 | six months of retention | 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 | six months of retention | 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 | six months of retention | 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 | six months of retention | Horizontal distance between right and left gonion points in millimeters |
| Inter-mental width | six months of retention | Horizontal distance between right and left mental foramen in millimeters |
| alveolar tipping angle | six months of retention | Angle between the tangent to palatal alveolar bone at right and left first molar and the mid sagittal plane |
| Dental tipping angle | six months of retention | 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 |
| Facial width | six months of retention | Horizontal distance between right and left zygomatico-temporal points in millimeter. |
| Bone density of the oral side of the Midpalatal suture | six months of retention | Average density in hounsfield units. |
| Upper airway dimension | six months of retention | Volume of the upper airway in mm3 |
| Intercanine width | six months of retention | Distance between the right and left canine cusp tips. |
| Intermolar width | six months of retention | Distance between the right and left central fossae of the permanent maxillary first molar |
| Inter-first premolar width | six months of retention | Distance between the right and left first premolar buccal cusp tips. |
| Inter-second premolar width | six months of retention | Distance between the right and left first premolar buccal cusp tips. |
| Pain score | Day 1 of appliance activation | Visual Analogue Scale from 1-100. Zero denoting no pain and 100 denoting the worst pain imaginable |
| Day on which pain on activation stopped | Two weeks | The day on which the patient reports no pain with appliance activation |
| Bone density of the nasal side of the Midpalatal suture | six months of retention | Average density in hounsfield units. |
| Inter-infraorbitale width | six months of retention | Horizontal distance between right and left infraorbitale points |
| Inter-lateral pterygoid width | six months of retention | Horizontal distance between right and left lateral pterygoid points in millimeters |
Countries
Egypt
Contacts
Primary ContactElAlkamy
Backup ContactHossam
Outcome results
None listed