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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05555719
Other study ID # 346/1137/16/10/19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date August 1, 2022

Study information

Verified date October 2022
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date August 1, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 13 Years to 16 Years
Eligibility 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


Intervention

Device:
Mandibular Protraction Appliance
Mandibular Protraction Appliance was installed on fixed orthodontic appliance
PowerScope Appliance
PowerScope Appliance was installed on fixed orthodontic appliance

Locations

Country Name City State
Egypt Abubakr Mohamed Fouad Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

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