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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04825951
Enrollment
33
Registered
2021-04-01
Start date
2021-05-01
Completion date
2021-12-30
Last updated
2023-02-03

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

Conditions

Malocclusion, Angle Class III

Keywords

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

Brief summary

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.

Detailed description

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.

Interventions

OTHERCS 2000

treating growing Skeletal growing Class III patients

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants and statistician will be blinded (double blind) to the intervention group. After data collection is completed, the randomization code will be broken to reveal the allocation group. The operator will be blinded during recording of the measurements.

Intervention model description

randomized controlled clinical trial, parallel design.

Eligibility

Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Soft tissue readings in millimeters6 monthsUL- E plane in millimeters LL- E plane in millimeters
Dental readings angles6 monthsU1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
Dental readings in millimeters6 monthsU1-NA millimeters L1-NB in millimeters.
Skeletal readings angles6 monthsSNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
Skeletal readings percetanges6 monthsLAFH in percentage
Skeletal readings in millimeters6 monthsWits appraisal in millimeters

Secondary

MeasureTime frameDescription
Changes in TMJ6 monthsanterior, posterior, superior and medial joint space in cubic milimeters.
Changes in airway6 monthsdifference in airway volume in cubic millimeters .

Countries

Egypt

Outcome results

None listed

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