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

Malocclusion, Angle Class III Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825951
• Other study ID #: 070320212
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Other:
• CS 2000
treating growing Skeletal growing Class III patients

Locations

Country	Name	City	State
Egypt	Alexandria University Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal readings angles	SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees	6 months
Primary	Skeletal readings percetanges	LAFH in percentage	6 months
Primary	Skeletal readings in millimeters	Wits appraisal in millimeters	6 months
Primary	Dental readings angles	U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees	6 months
Primary	Dental readings in millimeters	U1-NA millimeters L1-NB in millimeters.	6 months
Primary	Soft tissue readings in millimeters	UL- E plane in millimeters LL- E plane in millimeters	6 months
Secondary	Changes in airway	difference in airway volume in cubic millimeters .	6 months
Secondary	Changes in TMJ	anterior, posterior, superior and medial joint space in cubic milimeters.	6 months