Rapid Maxillary Expansion with Low Level Laser Therapy

NCT ID: NCT05586997

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-17

Study Completion Date

2026-03-30

Brief Summary

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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

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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.

Conditions

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Crossbite Malocclusion Cross Bite Maxillary Constriction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Bonded Rapid Maxillary Expansion

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

Group Type ACTIVE_COMPARATOR

Bonded-Hyrax

Intervention Type 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

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

Group Type EXPERIMENTAL

Bonded-Hyrax

Intervention Type 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

Bonded Rapid Maxillary Expansion and low-Level Laser therapy

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Rapid maxillary expansion (RME) low level laser therapy (LLLT)

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role collaborator

National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Hend Salah ElSayed

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hend S ElSayed, PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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Al-Azhar University

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ElAlkamy

Role: CONTACT

+20233371615 ext. 2143

Hossam

Role: CONTACT

+20233371615 ext. 2106

References

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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.

Reference Type BACKGROUND
PMID: 15825776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29072861 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24812743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21803251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20381753 (View on PubMed)

Other Identifiers

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18055

Identifier Type: -

Identifier Source: org_study_id

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