Rapid Maxillary Expansion with Low Level Laser Therapy

Phase 3

Recruiting

• Conditions: Cross Bite; Maxillary Constriction; Malocclusion; Crossbite
• Interventions: Device: Bonded-Hyrax; Combination Product: Bonded Rapid Maxillary Expansion and low-Level Laser therapy

• Registration Number: NCT05586997
• Lead Sponsor: National Research Centre, Egypt

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.

Study Timeline

• Study Start: 2019-05-17
• Study First Submitted: 2022-10-16
• Study First Submitted QC: 2022-10-16
• Study First Posted: 2022-10-19
• Status Verified: 2024-04
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bonded Rapid Maxillary Expansion and low-Level Laser	Bonded Rapid Maxillary Expansion and low-Level Laser therapy	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
Bonded Rapid Maxillary Expansion	Bonded-Hyrax	Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily
Bonded Rapid Maxillary Expansion and low-Level Laser	Bonded-Hyrax	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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
Bone density of the nasal side of the Midpalatal suture	six months of retention	Average density in hounsfield units.
Intermolar width	six months of retention	Distance between the right and left central fossae of the permanent maxillary first molar
Inter-second premolar width	six months of retention	Distance between the right and left first premolar buccal cusp tips.
Nasal width	six months of retention	Horizontal distance between right and left lateral nasale points in millimeters
Facial width	six months of retention	Horizontal distance between right and left zygomatico-temporal points in millimeter.
Inter-lateral pterygoid width	six months of retention	Horizontal distance between right and left lateral pterygoid points in millimeters
Inter-mental width	six months of retention	Horizontal distance between right and left mental foramen in millimeters
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
Inter-first premolar width	six months of retention	Distance between the right and left first premolar buccal cusp tips.
Inter-infraorbitale width	six months of retention	Horizontal distance between right and left infraorbitale points
Bi-gonial width	six months of retention	Horizontal distance between right and left gonion points in millimeters
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.
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.
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

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Cairo, Egypt