Clinical trial NCT04825951: Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class III
Keywords: Cone beam computed tomography
growing skeletal Class III
CS 2000® appliance
Reversed Forsus Fatigue resistant device
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial, parallel design.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skeletal readings angles
timeFrame: 6 months
measure: Skeletal readings percetanges
timeFrame: 6 months
measure: Skeletal readings in millimeters
timeFrame: 6 months
measure: Dental readings angles
timeFrame: 6 months
measure: Dental readings in millimeters
timeFrame: 6 months
measure: Soft tissue readings in millimeters
timeFrame: 6 months
Secondary outcomes:
measure: Changes in airway
timeFrame: 6 months
measure: Changes in TMJ
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Faculty of Dentistry
Study officials:
affiliation: Alexandria University
name: Bassant A Abbas, PHD resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliveira PM, Cheib-Vilefort PL, de Parsia Gontijo H, Melgaco CA, Franchi L, McNamara JA Jr, Souki BQ. Three-dimensional changes of the upper airway in patients with Class II malocclusion treated with the Herbst appliance: A cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2020 Feb;157(2):205-211. doi: 10.1016/j.ajodo.2019.03.021.
citation: World Medical Association.. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373-4. Epub 2003 Jul 2. No abstract available.