Rapid Maxillary Expansion with Low Level Laser Therapy

Effect of Rapid Maxillary Expansion with Low Level Laser Therapy Versus Rapid Maxillary Expansion in Children with Posterior Cross Bite

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.

Study Overview

• Status: Recruiting
• Conditions: Malocclusion; Cross Bite; Crossbite; Maxillary Constriction
• Intervention / Treatment: Device: Bonded-Hyrax; Combination product: Bonded Rapid Maxillary Expansion and low-Level Laser therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ElAlkamy; Phone Number: 2143 +20233371615; Email: aminaelalkamy@gmail.com
• Study Contact Backup: Name: Hossam; Phone Number: 2106 +20233371615; Email: hadeelhossam@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 18884
    • Recruiting
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bonded Rapid Maxillary Expansion; Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily	Device: Bonded-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; Other Names: Rapid maxillary expansion (RME)
Experimental: Bonded Rapid Maxillary Expansion and low-Level Laser; 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; 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; Other Names: Rapid maxillary expansion (RME); Combination product: Bonded 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; Other Names: low level laser therapy (LLLT)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt
• Collaborators: Al-Azhar University
• Investigators: Principal Investigator: Hend S ElSayed, PhD, National Research Centre, Egypt

Publications and helpful links

General Publications

• 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.
• 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.
• Kang Y, Rabie AB, Wong RW. A review of laser applications in orthodontics. Int J Orthod Milwaukee. 2014 Spring;25(1):47-56.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: bonded-Hyrax; Hyrax-expander; Maxillary constriction; Posterior cross bite; Rapid maxillary expansion
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathological Conditions, Anatomical; Tooth Diseases; Malocclusion; Constriction, Pathologic
• Other Study ID Numbers: 18055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No