Rapid Maxillary Expansion with Low Level Laser Therapy

National Research Centre, Egypt

Status and phase: Enrolling; Phase 3

Conditions: Malocclusion; Maxillary Constriction; Crossbite; Cross Bite

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05586997

18055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Bonded Rapid Maxillary Expansion

Active Comparator group

Description:

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

Treatment:

Device: Bonded-Hyrax

Bonded Rapid Maxillary Expansion and low-Level Laser

Experimental group

Description:

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

Treatment:

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

Device: Bonded-Hyrax