Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway

Mandibular Retrognathism Clinical Trial

Official title:

Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255511
• Other study ID #: A09061119
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.

Description:

The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Skeletal class II division 1 malocclusion due to mandibular retrognathism.

2. Cephalometric angular measurements: SNA = 82, SNB = 78, ANB = 4.

3. Overjet = 6 mm.

4. Patient in circumpubertal stage CVM2 and CVM3.

Exclusion Criteria:

1. History of orthodontic treatment.

2. Presence of craniofacial anomalies or TMJ disorders.

3. Systemic problems that may affect craniofacial growth.

4. Abnormal oral habits.

Related Conditions & MeSH terms

• ClassII Division 1 Malocclusion
• Malocclusion
• Mandibular Retrognathism
• Retrognathia

Intervention

Device:
• Twin Block
Functional appliance
• Fixed orthodontic appliance
Braces

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharyngeal airway volume	CBCT images will be used to measure the pharyngeal airway volume in mm3	One year
Primary	Nocturnal breathing	Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.	One year
Secondary	Maximum expiratory pressure	Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.	One year
Secondary	Craniofacial changes	Lateral cephalometric images extracted from the CBCT images will be used to measure linear (mm) skeletal, dental and soft tissue changes of maxilla and mandible.	One year
Secondary	Craniofacial changes	Lateral cephalometric images extracted from the CBCT images will be used to measure angular (º) skeletal, dental and soft tissue changes of maxilla and mandible.	One year