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CrossbitePhase 3NCT05586997

Rapid Maxillary Expansion with Low Level Laser Therapy

A Phase 3 study testing Bonded-Hyrax and Bonded Rapid Maxillary Expansion and low-Level Laser therapy in people with Crossbite and Malocclusion, run by National Research Centre, Egypt at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 14 years
Conditions the study is for
Crossbite, Malocclusion, Cross Bite
What is being tested?
Bonded-Hyrax and Bonded Rapid Maxillary Expansion and low-Level Laser therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
17 May 2019to 30 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Posterior crossbite
  • Patent mid-palatal suture
  • Mixed dentition or early permanent teeth
  • Subjects who reported no medical conditions or prolonged medications

Who cannot join

  • Poor oral hygiene
  • Active periodontal disease
  • Craniofacial abnormalities
  • Previous orthodontic treatment
  • Any systemic disease or medication that might affect bone metabolism.

Trial locations and contacts

1 site in 1 country.

ElAlkamy contact

+20233371615 ext. 2143

aminaelalkamy@gmail.com

Hossam contact

+20233371615 ext. 2106

hadeelhossam@gmail.com

Egypt1 site, 1 recruiting

  • Al-Azhar University

    Cairo, Cairo Governorate, 18884

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

Being tested
Bonded-Hyrax, Bonded Rapid Maxillary Expansion and low-Level Laser therapy
Keywords
bonded-Hyrax, Hyrax-expander, Maxillary constriction, Posterior cross bite, Rapid maxillary expansion
Medical subject headings
Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bonded-HyraxDevice

    Also called Rapid maxillary expansion (RME)

    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

  • Bonded Rapid Maxillary Expansion and low-Level Laser therapyCombination product

    Also called low level laser therapy (LLLT)

    Ten sessions of 0.5 watts for 20 seconds at 4 points along the mid-palatal suture

Study groups in NCT05586997
Study groupRoleWhat they receive
Bonded Rapid Maxillary ExpansionActive comparatorBonded-hyrax with a 7mm expansion screw activated a full turn twice daily
Receives: Device: Bonded-Hyrax
Bonded Rapid Maxillary Expansion and low-Level LaserExperimentalBonded-hyrax with a 7mm expansion screw activated a full turn twice daily with 10 sessions of Indium Gallium Arsenide Phosphoride (940nm) semiconductor diode laser
Receives: Device: Bonded-Hyrax; Combination Product: Bonded Rapid Maxillary Expansion and low-Level Laser therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inter-jugale width

    Horizontal distance between right and left Jugale points, in millimeters.

    Measured: six months of retention

  2. 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.

    Measured: six months of retention

  3. Bone density of the mid-palatal suture

    Average density of 200mm3 volume, in hounsfield units.

    Measured: six months of retention

Secondary outcomes (21)

  1. Facial width

    Horizontal distance between right and left zygomatico-temporal points in millimeter.

    Measured: six months of retention

  2. Inter-infraorbitale width

    Horizontal distance between right and left infraorbitale points

    Measured: six months of retention

  3. Inter-lateral pterygoid width

    Horizontal distance between right and left lateral pterygoid points in millimeters

    Measured: six months of retention

  4. Nasal width

    Horizontal distance between right and left lateral nasale points in millimeters

    Measured: six months of retention

  5. 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.

    Measured: six months of retention

  6. 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

    Measured: six months of retention

  7. 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.

    Measured: six months of retention

  8. 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.

    Measured: six months of retention

  9. Bi-gonial width

    Horizontal distance between right and left gonion points in millimeters

    Measured: six months of retention

  10. Inter-mental width

    Horizontal distance between right and left mental foramen in millimeters

    Measured: six months of retention

  11. alveolar tipping angle

    Angle between the tangent to palatal alveolar bone at right and left first molar and the mid sagittal plane

    Measured: six months of retention

  12. 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

    Measured: six months of retention

  13. Bone density of the nasal side of the Midpalatal suture

    Average density in hounsfield units.

    Measured: six months of retention

  14. Bone density of the oral side of the Midpalatal suture

    Average density in hounsfield units.

    Measured: six months of retention

  15. Upper airway dimension

    Volume of the upper airway in mm3

    Measured: six months of retention

  16. Intercanine width

    Distance between the right and left canine cusp tips.

    Measured: six months of retention

  17. Intermolar width

    Distance between the right and left central fossae of the permanent maxillary first molar

    Measured: six months of retention

  18. Inter-first premolar width

    Distance between the right and left first premolar buccal cusp tips.

    Measured: six months of retention

  19. Inter-second premolar width

    Distance between the right and left first premolar buccal cusp tips.

    Measured: six months of retention

  20. Pain score

    Visual Analogue Scale from 1-100. Zero denoting no pain and 100 denoting the worst pain imaginable

    Measured: Day 1 of appliance activation

  21. Day on which pain on activation stopped

    The day on which the patient reports no pain with appliance activation

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start17 May 2019
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586997
Sponsor's protocol ID
18055
Status last verified
Apr 2024
First submitted
16 Oct 2022
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 15825776

  • 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.

    PubMed 29072861

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

    PubMed 24812743

  • 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.

    PubMed 21803251

  • 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.

    PubMed 20381753

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bonded-Hyrax and Bonded Rapid Maxillary Expansion and low-Level Laser therapy in people with Crossbite and Malocclusion, run by National Research Centre, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ElAlkamy (+20233371615 ext. 2143, aminaelalkamy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inter-jugale width (time frame: six months of retention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586997, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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