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

Not Applicable

Completed

• Conditions: Class II Malocclusion
• Interventions: Device: Mandibular Protraction Appliance; Device: PowerScope Appliance

• Registration Number: NCT05555719
• Lead Sponsor: Al-Azhar University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mandibular Protraction Appliance	Mandibular Protraction Appliance	the first group that received Mandibular Protraction Appliance
PowerScope Appliances	PowerScope Appliance	the first group that received PowerScope Appliances

Primary Outcome Measures

Name	Time	Method
SNB angle (on Cephalometric radiograph)	6 months	Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)
SNA angle (on Cephalometric radiograph)	6 months	Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)
ANB angle (on Cephalometric radiograph)	6 months	The relationaship between maxilla and mandible
Mandibular incisors inclination (angle) (on Cephalometric radiograph)	6 months	The change of mandibular incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)
Effective mandibular length (mm) (on Cephalometric radiograph)	6 months	the length of the mandible (change in length before and after treatment)
Mandibular plane angle (on Cephalometric radiograph)	6 months	the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line)
Maxillary incisors inclination (angle) (on Cephalometric radiograph)	6 months	The change of maxillary incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)

Secondary Outcome Measures

Name	Time	Method
Upper lip retrusion (mm) (on Cephalometric radiograph)	6 months	the amount of upper lip retrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)
Lower lip protrusion (on Cephalometric radiograph)	6 months	the amount of lower lip protrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)

Trial Locations

Locations (1)

Abubakr Mohamed Fouad; 🇪🇬 Cairo, Egypt