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

Primary Purpose

Malocclusion, Angle Class III

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CS 2000
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class III focused on measuring Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age range from 9 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.(20)
  • Congenitally missing teeth or extracted teeth.
  • History of systemic disease or craniofacial syndromes or presence of cleft.

Sites / Locations

  • Alexandria University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

CS 2000 appliance

Reversed Forsus Fatigue resistant appliance

Control

Arm Description

treating growing skeletal Class III patients

treating growing skeletal Class III patients

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in airway
difference in airway volume in cubic millimeters .
Changes in TMJ
anterior, posterior, superior and medial joint space in cubic milimeters.

Full Information

First Posted
March 26, 2021
Last Updated
February 2, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04825951
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class III
Keywords
Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled clinical trial, parallel design.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS 2000 appliance
Arm Type
Active Comparator
Arm Description
treating growing skeletal Class III patients
Arm Title
Reversed Forsus Fatigue resistant appliance
Arm Type
Active Comparator
Arm Description
treating growing skeletal Class III patients
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CS 2000
Other Intervention Name(s)
Reversed Forsus Fatigue resistant appliance
Intervention Description
treating growing Skeletal growing Class III patients
Primary Outcome Measure Information:
Title
Skeletal readings angles
Description
SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
Time Frame
6 months
Title
Skeletal readings percetanges
Description
LAFH in percentage
Time Frame
6 months
Title
Skeletal readings in millimeters
Description
Wits appraisal in millimeters
Time Frame
6 months
Title
Dental readings angles
Description
U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
Time Frame
6 months
Title
Dental readings in millimeters
Description
U1-NA millimeters L1-NB in millimeters.
Time Frame
6 months
Title
Soft tissue readings in millimeters
Description
UL- E plane in millimeters LL- E plane in millimeters
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in airway
Description
difference in airway volume in cubic millimeters .
Time Frame
6 months
Title
Changes in TMJ
Description
anterior, posterior, superior and medial joint space in cubic milimeters.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant A Abbas, PHD resident
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University Faculty of Dentistry
City
Alexandria
ZIP/Postal Code
03
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
TREATMENT OF GROWING SKELETAL CLASS III PATIENTS
Citations:
PubMed Identifier
32005472
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.
Results Reference
background
PubMed Identifier
11357217
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.
Results Reference
result

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

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