Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study

Class II Malocclusion Clinical Trial

Official title:

Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05555719
• Other study ID #: 346/1137/16/10/19
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases

Description:

Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance. the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

Inclusion Criteria:

1. Skeletal and dental class II malocclusion with mandibular retrognathia, SNB>= 4.

2. Patients in cervical vertebral maturation index 3 -5.

3. Age ranged from 13-16 years.

4. Overjet = 5 mm.

5. Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).

6. Good oral hygiene and general health.

7. No previous orthodontic treatment or jaw's surgery.

Exclusion Criteria:

• Class I skeletal malocclusion
• periodontally compromised patient
• patients have systemic diseases interfering with orthodontic treatment

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• Mandibular Protraction Appliance
Mandibular Protraction Appliance was installed on fixed orthodontic appliance
• PowerScope Appliance
PowerScope Appliance was installed on fixed orthodontic appliance

Locations

Country	Name	City	State
Egypt	Abubakr Mohamed Fouad	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNA angle (on Cephalometric radiograph)	Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)	6 months
Primary	SNB angle (on Cephalometric radiograph)	Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)	6 months
Primary	ANB angle (on Cephalometric radiograph)	The relationaship between maxilla and mandible	6 months
Primary	Effective mandibular length (mm) (on Cephalometric radiograph)	the length of the mandible (change in length before and after treatment)	6 months
Primary	Mandibular plane angle (on Cephalometric radiograph)	the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line)	6 months
Primary	Maxillary incisors inclination (angle) (on Cephalometric radiograph)	The change of maxillary incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)	6 months
Primary	Mandibular incisors inclination (angle) (on Cephalometric radiograph)	The change of mandibular incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)	6 months
Secondary	Upper lip retrusion (mm) (on Cephalometric radiograph)	the amount of upper lip retrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)	6 months
Secondary	Lower lip protrusion (on Cephalometric radiograph)	the amount of lower lip protrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)	6 months