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

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class III
• Interventions: Other: CS 2000

• Registration Number: NCT04825951
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Study Start: 2021-05-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-02
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reversed Forsus Fatigue resistant appliance	CS 2000	treating growing skeletal Class III patients
CS 2000 appliance	CS 2000	treating growing skeletal Class III patients

Primary Outcome Measures

Name	Time	Method
Skeletal readings in millimeters	6 months	Wits appraisal in millimeters
Skeletal readings percetanges	6 months	LAFH in percentage
Dental readings angles	6 months	U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
Dental readings in millimeters	6 months	U1-NA millimeters L1-NB in millimeters.
Skeletal readings angles	6 months	SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
Soft tissue readings in millimeters	6 months	UL- E plane in millimeters LL- E plane in millimeters

Secondary Outcome Measures

Name	Time	Method
Changes in airway	6 months	difference in airway volume in cubic millimeters .
Changes in TMJ	6 months	anterior, posterior, superior and medial joint space in cubic milimeters.

Trial Locations

Locations (1)

Alexandria University Faculty of Dentistry; 🇪🇬 Alexandria, Egypt