Rapid Maxillary Expansion with Low Level Laser Therapy

February 20, 2025 updated by: Hend Salah ElSayed, National Research Centre, Egypt

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inter-jugale width
Time Frame: six months of retention
Horizontal distance between right and left Jugale points, in millimeters.
six months of retention
Buccal maxillary width
Time Frame: 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.
six months of retention
Bone density of the mid-palatal suture
Time Frame: six months of retention
Average density of 200mm3 volume, in hounsfield units.
six months of retention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Facial width
Time Frame: six months of retention
Horizontal distance between right and left zygomatico-temporal points in millimeter.
six months of retention
Inter-infraorbitale width
Time Frame: six months of retention
Horizontal distance between right and left infraorbitale points
six months of retention
Inter-lateral pterygoid width
Time Frame: six months of retention
Horizontal distance between right and left lateral pterygoid points in millimeters
six months of retention
Nasal width
Time Frame: six months of retention
Horizontal distance between right and left lateral nasale points in millimeters
six months of retention
Palatal maxillary width
Time Frame: 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.
six months of retention
Buccal alveolar bone thickness at the mesiobuccal root of the first maxillary permanent molar
Time Frame: 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
six months of retention
Buccal alveolar bone thickness at the distobuccal root of the first maxillary permanent molar
Time Frame: 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.
six months of retention
Palatal bone thickness
Time Frame: 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.
six months of retention
Bi-gonial width
Time Frame: six months of retention
Horizontal distance between right and left gonion points in millimeters
six months of retention
Inter-mental width
Time Frame: six months of retention
Horizontal distance between right and left mental foramen in millimeters
six months of retention
alveolar tipping angle
Time Frame: six months of retention
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
Time Frame: 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
six months of retention
Bone density of the nasal side of the Midpalatal suture
Time Frame: six months of retention
Average density in hounsfield units.
six months of retention
Bone density of the oral side of the Midpalatal suture
Time Frame: six months of retention
Average density in hounsfield units.
six months of retention
Upper airway dimension
Time Frame: six months of retention
Volume of the upper airway in mm3
six months of retention
Intercanine width
Time Frame: six months of retention
Distance between the right and left canine cusp tips.
six months of retention
Intermolar width
Time Frame: six months of retention
Distance between the right and left central fossae of the permanent maxillary first molar
six months of retention
Inter-first premolar width
Time Frame: six months of retention
Distance between the right and left first premolar buccal cusp tips.
six months of retention
Inter-second premolar width
Time Frame: six months of retention
Distance between the right and left first premolar buccal cusp tips.
six months of retention
Pain score
Time Frame: Day 1 of appliance activation
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
Time Frame: Two weeks
The day on which the patient reports no pain with appliance activation
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Research Centre, Egypt

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Al-Azhar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hend S ElSayed, PhD, National Research Centre, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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