Rapid Maxillary Expansion With Low Level Laser Therapy

Malocclusion Clinical Trial

Official title:

Effect of Rapid Maxillary Expansion With Low Level Laser Therapy Versus Rapid Maxillary Expansion in Children With Posterior Cross Bite

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586997
• Other study ID #: 18055
• Status: Recruiting
• Phase: Phase 3
• Start date: May 17, 2019
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: National Research Centre, Egypt
• Contact: ElAlkamy
• Phone: +20233371615
• Email: aminaelalkamy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Cross Bite
• Crossbite
• Malocclusion
• Maxillary Constriction

Intervention

Device:
• 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

Combination Product:
• 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

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre, Egypt	Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-jugale width	Horizontal distance between right and left Jugale points, in millimeters.	six months of retention
Primary	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
Primary	Bone density of the mid-palatal suture	Average density of 200mm3 volume, in hounsfield units.	six months of retention
Secondary	Facial width	Horizontal distance between right and left zygomatico-temporal points in millimeter.	six months of retention
Secondary	Inter-infraorbitale width	Horizontal distance between right and left infraorbitale points	six months of retention
Secondary	Inter-lateral pterygoid width	Horizontal distance between right and left lateral pterygoid points in millimeters	six months of retention
Secondary	Nasal width	Horizontal distance between right and left lateral nasale points in millimeters	six months of retention
Secondary	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.	six months of retention
Secondary	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	six months of retention
Secondary	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.	six months of retention
Secondary	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.	six months of retention
Secondary	Bi-gonial width	Horizontal distance between right and left gonion points in millimeters	six months of retention
Secondary	Inter-mental width	Horizontal distance between right and left mental foramen in millimeters	six months of retention
Secondary	alveolar tipping angle	Angle between the tangent to palatal alveolar bone at right and left first molar and the mid sagittal plane	six months of retention
Secondary	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	six months of retention
Secondary	Bone density of the nasal side of the Midpalatal suture	Average density in hounsfield units.	six months of retention
Secondary	Bone density of the oral side of the Midpalatal suture	Average density in hounsfield units.	six months of retention
Secondary	Upper airway dimension	Volume of the upper airway in mm3	six months of retention
Secondary	Intercanine width	Distance between the right and left canine cusp tips.	six months of retention
Secondary	Intermolar width	Distance between the right and left central fossae of the permanent maxillary first molar	six months of retention
Secondary	Inter-first premolar width	Distance between the right and left first premolar buccal cusp tips.	six months of retention
Secondary	Inter-second premolar width	Distance between the right and left first premolar buccal cusp tips.	six months of retention
Secondary	Pain score	Visual Analogue Scale from 1-100. Zero denoting no pain and 100 denoting the worst pain imaginable	Day 1 of appliance activation
Secondary	Day on which pain on activation stopped	The day on which the patient reports no pain with appliance activation	Two weeks