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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05555719

Enrollment

Registered

2022-09-27

Start date

2019-11-01

Completion date

2022-08-01

Last updated

2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class II Malocclusion

Keywords

PowerScope, Mandibular Protraction Appliance

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

Interventions

DEVICEMandibular Protraction Appliance

Mandibular Protraction Appliance was installed on fixed orthodontic appliance

DEVICEPowerScope Appliance

PowerScope Appliance was installed on fixed orthodontic appliance

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

2 treatment groups, both have class II malocclusion

Eligibility

Sex/Gender

ALL

Age

13 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)
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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026