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

Primary Purpose

Class II Malocclusion

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Mandibular Protraction Appliance

PowerScope Appliance

About this trial

This is an interventional treatment trial for Class II Malocclusion focused on measuring PowerScope, Mandibular Protraction Appliance

Eligibility Criteria

13 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Abubakr Mohamed Fouad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mandibular Protraction Appliance

PowerScope Appliances

Arm Description

the first group that received Mandibular Protraction Appliance

the first group that received PowerScope Appliances

Outcomes

Primary Outcome Measures

SNA angle (on Cephalometric radiograph)

Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)

SNB angle (on Cephalometric radiograph)

Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)

ANB angle (on Cephalometric radiograph)

The relationaship between maxilla and mandible

Effective mandibular length (mm) (on Cephalometric radiograph)

the length of the mandible (change in length before and after treatment)

Mandibular plane angle (on Cephalometric radiograph)

the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line)

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)

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)

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT05555719

First Posted

September 21, 2022

Last Updated

October 12, 2022

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05555719

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

August 1, 2022 (Actual)

Study Completion Date

August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Class II Malocclusion

Keywords

PowerScope, Mandibular Protraction Appliance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

2 treatment groups, both have class II malocclusion

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mandibular Protraction Appliance

Arm Type

Experimental

Arm Description

the first group that received Mandibular Protraction Appliance

Arm Title

PowerScope Appliances

Arm Type

Experimental

Arm Description

the first group that received PowerScope Appliances

Intervention Type

Device

Intervention Name(s)

Mandibular Protraction Appliance

Intervention Description

Mandibular Protraction Appliance was installed on fixed orthodontic appliance

Intervention Type

Device

Intervention Name(s)

PowerScope Appliance

Intervention Description

PowerScope Appliance was installed on fixed orthodontic appliance

Primary Outcome Measure Information:

Title

SNA angle (on Cephalometric radiograph)

Description

Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)

Time Frame

6 months

Title

SNB angle (on Cephalometric radiograph)

Description

Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)

Time Frame

6 months

Title

ANB angle (on Cephalometric radiograph)

Description

The relationaship between maxilla and mandible

Time Frame

6 months

Title

Effective mandibular length (mm) (on Cephalometric radiograph)

Description

the length of the mandible (change in length before and after treatment)

Time Frame

6 months

Title

Mandibular plane angle (on Cephalometric radiograph)

Description

the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line)

Time Frame

6 months

Title

Maxillary incisors inclination (angle) (on Cephalometric radiograph)

Description

The change of maxillary incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)

Time Frame

6 months

Title

Mandibular incisors inclination (angle) (on Cephalometric radiograph)

Description

The change of mandibular incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Upper lip retrusion (mm) (on Cephalometric radiograph)

Description

the amount of upper lip retrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)

Time Frame

6 months

Title

Lower lip protrusion (on Cephalometric radiograph)

Description

the amount of lower lip protrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Class I skeletal malocclusion periodontally compromised patient patients have systemic diseases interfering with orthodontic treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abubakr M Fouad

Organizational Affiliation

Al-azhar university, Cairo - Egypt

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abubakr Mohamed Fouad

City

Cairo

ZIP/Postal Code

002

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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