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

NCT04825951 | Completed DMC

• 1 other identifier: 070320212
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class III

Keywords

Cone beam computed tomography; growing skeletal Class III; CS 2000® appliance; Reversed Forsus Fatigue resistant device

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Changes in airway

  6 months

• Changes in TMJ

  6 months

Study Arms (3)

CS 2000 appliance

ACTIVE COMPARATOR

treating growing skeletal Class III patients

Other: CS 2000

Reversed Forsus Fatigue resistant appliance

ACTIVE COMPARATOR

treating growing skeletal Class III patients

Other: CS 2000

Control

NO INTERVENTION

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.

Interventions

CS 2000 OTHER

treating growing Skeletal growing Class III patients

Also known as: Reversed Forsus Fatigue resistant appliance

CS 2000 appliance; Reversed Forsus Fatigue resistant appliance

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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˚).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Dentistry

Alexandria, 03, Egypt

Location

Related 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.

  PMID: 32005472 BACKGROUND

• 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.

  PMID: 11357217 RESULT

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bassant A Abbas, PHD resident

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and statistician will be blinded (double blind) to the intervention group. After data collection is completed, the randomization code will be broken to reveal the allocation group. The operator will be blinded during recording of the measurements.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized controlled clinical trial, parallel design.

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 1, 2021
• Study Start: May 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)