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NCT Number: NCT04825951

Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients

Early orthodontic treatment of Class III malocclusions with skeletal and dentoalveolar imbalances, represents a continuous dilemma. This difficulty starts from their meticulous diagnosis and treatment planning till reaching satisfactory results and finally stability. Some appliances could be used to correct growing skeletal Class III patients, improving the skeletal and dentoalveolar relationships, creating proper conditions for final orthodontic treatment, more importantly avoiding surgery. These appliances remove patient compliance from the equation.

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Key information

Conditions

Malocclusion, Angle Class III Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University Faculty of Dentistry

Alexandria, 03, Egypt

About this study

Aim of the work: Evaluate the skeletal, dentoalveolar and soft tissue effects of two different force application systems which are the pulling force (CS 2000® appliance/ CS appliance) and the pushing force (Reversed Forsus fatigue-resistant device/ RF appliance).

Materials and methods: A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty three growing skeletal Class III patients (9-11 years) will be recruited upon a lateral cephalometric x-ray. Subjects complying with the inclusion criteria will be randomly assigned using a computer-generated list to one of the three groups Group I: Eleven patients treated with CS2000 appliance, Group II: Eleven patients treated with reversed Forsus Fatigue Resistant device and Group III: control group of Eleven untreated patients with a ratio of 1:1:1 allocation. A CBCT will be made before installing the appliances. After gaining a 2 mm positive overjet or a 6 months period, alginate impressions will be poured and dental casts will be made. Photographs and CBCTs will also be performed to record the dentofacial effect of the used appliances.

Keywords: Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age range from 8 years to 11 years.
  • Cervical vertebrae maturation index (CVMI 2 and 3) identified on the lateral cephalometric radiograph.
  • Angle Class III molar relation.
  • Skeletal class III ANB ranges between (-4) - (0).
  • Wits appraisal ranges between (0) - (-5).
  • Patients with good oral hygiene, and a healthy periodontal condition.
  • Reversed over jet (-1) - (-6).
  • Normal vertical growth pattern (SN/MP angle 28˚-38˚).

Exclusion criteria

  • A discrepancy between centric relation and maximum intercuspation.
  • Patients who underwent previous orthodontic treatment.
  • Patients currently receiving drug therapy that may affect orthodontic tooth movement.
  • Congenitally missing teeth or extracted teeth.
  • History of systemic disease or craniofacial syndromes or presence of cleft.

Treatment and study plan

CS 2000

Other

treating growing Skeletal growing Class III patients

Other names: Reversed Forsus Fatigue resistant appliance

Primary outcomes

  1. Skeletal readings angles

    Time frame: 6 months

    SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees

  2. Skeletal readings percetanges

    Time frame: 6 months

    LAFH in percentage

  3. Skeletal readings in millimeters

    Time frame: 6 months

    Wits appraisal in millimeters

  4. Dental readings angles

    Time frame: 6 months

    U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees

  5. Dental readings in millimeters

    Time frame: 6 months

    U1-NA millimeters L1-NB in millimeters.

  6. Soft tissue readings in millimeters

    Time frame: 6 months

    UL- E plane in millimeters LL- E plane in millimeters

Secondary outcomes

  1. Changes in airway

    Time frame: 6 months

    difference in airway volume in cubic millimeters .

  2. Changes in TMJ

    Time frame: 6 months

    anterior, posterior, superior and medial joint space in cubic milimeters.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Three Dimensional Evaluation Of Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients (A Randomized Controlled Clinical Trial)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Feb 3, 2023

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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