An interventional study of CS 2000 in Malocclusion, Angle Class III, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-03.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
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.
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.
57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.
This study's enrollment of 33 is close to the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.
Browse Malocclusion, Angle Class III studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
treating growing skeletal Class III patients
Other: CS 2000
treating growing skeletal Class III patients
Other: CS 2000
A group of untreated skeletally growing class III patients will be recruited to account for the possible effects of growth in the treatment groups. This group matches the treated groups in malocclusion, stages of skeletal maturation, and mean observation period. Those patients will be treated after the period of the study.
treating growing Skeletal growing Class III patients
Also known as: Reversed Forsus Fatigue resistant appliance
Skeletal readings angles
SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
Time frame: 6 months
Skeletal readings percetanges
LAFH in percentage
Time frame: 6 months
Skeletal readings in millimeters
Wits appraisal in millimeters
Time frame: 6 months
Dental readings angles
U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
Time frame: 6 months
Dental readings in millimeters
U1-NA millimeters L1-NB in millimeters.
Time frame: 6 months
Soft tissue readings in millimeters
UL- E plane in millimeters LL- E plane in millimeters
Time frame: 6 months
Changes in airway
difference in airway volume in cubic millimeters .
Time frame: 6 months
Changes in TMJ
anterior, posterior, superior and medial joint space in cubic milimeters.
Time frame: 6 months
Plan to share: No — TREATMENT OF GROWING SKELETAL CLASS III PATIENTS
Ran from May 2021 to primary completion in Dec 2021, 7 months.
Of 37 non-industry interventional studies with no phase under Malocclusion, Angle Class III, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 7 months is below that.
Counting every sponsor, half of 38 studies reached it within 13 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Malocclusion, Angle Class III →