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)

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class III
• Intervention / Treatment: Other: CS 2000

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 03
    • Alexandria University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CS 2000 appliance; treating growing skeletal Class III patients	Other: CS 2000; treating growing Skeletal growing Class III patients; Other Names: Reversed Forsus Fatigue resistant appliance
Active Comparator: Reversed Forsus Fatigue resistant appliance; treating growing skeletal Class III patients	Other: CS 2000; treating growing Skeletal growing Class III patients; Other Names: Reversed Forsus Fatigue resistant appliance
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in airway	difference in airway volume in cubic millimeters .	6 months
Changes in TMJ	anterior, posterior, superior and medial joint space in cubic milimeters.	6 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Bassant A Abbas, PHD resident, Alexandria University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cone beam computed tomography; growing skeletal Class III; CS 2000® appliance; Reversed Forsus Fatigue resistant device
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: 070320212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: TREATMENT OF GROWING SKELETAL CLASS III PATIENTS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No