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

NCT05555719 | Completed

• 1 other identifier: 346/1137/16/10/19
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Class II Malocclusion

Keywords

PowerScope; Mandibular Protraction Appliance

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Upper lip retrusion (mm) (on Cephalometric radiograph)

  6 months

• Lower lip protrusion (on Cephalometric radiograph)

  6 months

Study Arms (2)

Mandibular Protraction Appliance

EXPERIMENTAL

the first group that received Mandibular Protraction Appliance

Device: Mandibular Protraction Appliance

PowerScope Appliances

EXPERIMENTAL

the first group that received PowerScope Appliances

Device: PowerScope Appliance

Interventions

Mandibular Protraction Appliance DEVICE

Mandibular Protraction Appliance was installed on fixed orthodontic appliance

Mandibular Protraction Appliance

PowerScope Appliance DEVICE

PowerScope Appliance was installed on fixed orthodontic appliance

PowerScope Appliances

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal and dental class II malocclusion with mandibular retrognathia, SNB\>= 4.
• Patients in cervical vertebral maturation index 3 -5.
• Age ranged from 13-16 years.
• Overjet ≥ 5 mm.
• Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).
• Good oral hygiene and general health.
• No previous orthodontic treatment or jaw's surgery.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Abubakr Mohamed Fouad

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abubakr M Fouad

  Al-azhar university, Cairo - Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, orthodontic department, Al Azhar university Cairo Boys

Model Details: 2 treatment groups, both have class II malocclusion

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 27, 2022
• Study Start: November 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Locations

EG (1)