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Completed

NCT Number: NCT05555719

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

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Key information

Conditions

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

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abubakr Mohamed Fouad

Cairo, 002, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular Protraction Appliance

Device

Mandibular Protraction Appliance was installed on fixed orthodontic appliance

PowerScope Appliance

Device

PowerScope Appliance was installed on fixed orthodontic appliance

Primary outcomes

  1. SNA angle (on Cephalometric radiograph)

    Time frame: 6 months

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

  2. SNB angle (on Cephalometric radiograph)

    Time frame: 6 months

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

  3. ANB angle (on Cephalometric radiograph)

    Time frame: 6 months

    The relationaship between maxilla and mandible

  4. Effective mandibular length (mm) (on Cephalometric radiograph)

    Time frame: 6 months

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

  5. Mandibular plane angle (on Cephalometric radiograph)

    Time frame: 6 months

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

  6. Maxillary incisors inclination (angle) (on Cephalometric radiograph)

    Time frame: 6 months

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

  7. Mandibular incisors inclination (angle) (on Cephalometric radiograph)

    Time frame: 6 months

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

Secondary outcomes

  1. Upper lip retrusion (mm) (on Cephalometric radiograph)

    Time frame: 6 months

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

  2. Lower lip protrusion (on Cephalometric radiograph)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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