Clinical trial NCT05586997: Rapid Maxillary Expansion with Low Level Laser Therapy
Official title: Effect of Rapid Maxillary Expansion with Low Level Laser Therapy Versus Rapid Maxillary Expansion in Children with Posterior Cross Bite
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crossbite
Malocclusion
Cross Bite
Maxillary Constriction
Keywords: bonded-Hyrax
Hyrax-expander
Maxillary constriction
Posterior cross bite
Rapid maxillary expansion
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2022-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inter-jugale width
timeFrame: six months of retention
measure: Buccal maxillary width
timeFrame: six months of retention
measure: Bone density of the mid-palatal suture
timeFrame: six months of retention
Secondary outcomes:
measure: Facial width
timeFrame: six months of retention
measure: Inter-infraorbitale width
timeFrame: six months of retention
measure: Inter-lateral pterygoid width
timeFrame: six months of retention
measure: Nasal width
timeFrame: six months of retention
measure: Palatal maxillary width
timeFrame: six months of retention
measure: Buccal alveolar bone thickness at the mesiobuccal root of the first maxillary permanent molar
timeFrame: six months of retention
measure: Buccal alveolar bone thickness at the distobuccal root of the first maxillary permanent molar
timeFrame: six months of retention
measure: Palatal bone thickness
timeFrame: six months of retention
measure: Bi-gonial width
timeFrame: six months of retention
measure: Inter-mental width
timeFrame: six months of retention
measure: alveolar tipping angle
timeFrame: six months of retention
measure: Dental tipping angle
timeFrame: six months of retention
measure: Bone density of the nasal side of the Midpalatal suture
timeFrame: six months of retention
measure: Bone density of the oral side of the Midpalatal suture
timeFrame: six months of retention
measure: Upper airway dimension
timeFrame: six months of retention
measure: Intercanine width
timeFrame: six months of retention
measure: Intermolar width
timeFrame: six months of retention
measure: Inter-first premolar width
timeFrame: six months of retention
measure: Inter-second premolar width
timeFrame: six months of retention
measure: Pain score
timeFrame: Day 1 of appliance activation
measure: Day on which pain on activation stopped
timeFrame: Two weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar University
Study officials:
affiliation: National Research Centre, Egypt
name: Hend S ElSayed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Kang Y, Rabie AB, Wong RW. A review of laser applications in orthodontics. Int J Orthod Milwaukee. 2014 Spring;25(1):47-56.
citation: 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.
citation: 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.