Rapid Maxillary Expansion with Low Level Laser Therapy

NCT05586997 | Recruiting Phase 3

• 1 other identifier: 18055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Crossbite; Malocclusion; Cross Bite; Maxillary Constriction

Keywords

bonded-Hyrax; Hyrax-expander; Maxillary constriction; Posterior cross bite; Rapid maxillary expansion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (21)

• Facial width

  six months of retention

• Inter-infraorbitale width

  six months of retention

• Inter-lateral pterygoid width

  six months of retention

• Nasal width

  six months of retention

• Palatal maxillary width

  six months of retention

Study Arms (2)

Bonded Rapid Maxillary Expansion

ACTIVE COMPARATOR

Bonded-hyrax with a 7mm expansion screw activated a full turn twice daily

Device: Bonded-Hyrax

Bonded Rapid Maxillary Expansion and low-Level Laser

EXPERIMENTAL

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; Combination Product: Bonded Rapid Maxillary Expansion and low-Level Laser therapy

Interventions

Bonded-Hyrax DEVICE

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

Also known as: Rapid maxillary expansion (RME)

Bonded Rapid Maxillary Expansion; Bonded Rapid Maxillary Expansion and low-Level Laser

Bonded Rapid Maxillary Expansion and low-Level Laser therapy COMBINATION_PRODUCT

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

Also known as: low level laser therapy (LLLT)

Bonded Rapid Maxillary Expansion and low-Level Laser

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Research Centre, Egypt: lead
• Al-Azhar University: collaborator

Study Sites (1)

Al-Azhar University

Cairo, Cairo Governorate, 18884, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 15825776 BACKGROUND

• 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.

  PMID: 29072861 BACKGROUND

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

  PMID: 24812743 BACKGROUND

• 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.

  PMID: 21803251 BACKGROUND

• 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.

  PMID: 20381753 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Hend S ElSayed, PhD

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ElAlkamy

CONTACT

+20233371615; aminaelalkamy@gmail.com

Hossam

CONTACT

+20233371615; hadeelhossam@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: May 17, 2019
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: February 24, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)