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

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

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Device: Mandibular Protraction Appliance; Device: PowerScope Appliance

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Abubakr Mohamed Fouad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mandibular Protraction Appliance; the first group that received Mandibular Protraction Appliance	Device: Mandibular Protraction Appliance; Mandibular Protraction Appliance was installed on fixed orthodontic appliance
Experimental: PowerScope Appliances; the first group that received PowerScope Appliances	Device: PowerScope Appliance; PowerScope Appliance was installed on fixed orthodontic appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNA angle (on Cephalometric radiograph)	Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)	6 months
SNB angle (on Cephalometric radiograph)	Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)	6 months
ANB angle (on Cephalometric radiograph)	The relationaship between maxilla and mandible	6 months
Effective mandibular length (mm) (on Cephalometric radiograph)	the length of the mandible (change in length before and after treatment)	6 months
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Abubakr M Fouad, Al-azhar university, Cairo - Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: PowerScope; Mandibular Protraction Appliance
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 346/1137/16/10/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No