- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825951
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)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt, 03
- Alexandria University Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CS 2000 appliance
treating growing skeletal Class III patients
|
treating growing Skeletal growing Class III patients
Other Names:
|
Active Comparator: Reversed Forsus Fatigue resistant appliance
treating growing skeletal Class III patients
|
treating growing Skeletal growing Class III patients
Other Names:
|
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
Time Frame: 6 months
|
SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
|
6 months
|
Skeletal readings percetanges
Time Frame: 6 months
|
LAFH in percentage
|
6 months
|
Skeletal readings in millimeters
Time Frame: 6 months
|
Wits appraisal in millimeters
|
6 months
|
Dental readings angles
Time Frame: 6 months
|
U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
|
6 months
|
Dental readings in millimeters
Time Frame: 6 months
|
U1-NA millimeters L1-NB in millimeters.
|
6 months
|
Soft tissue readings in millimeters
Time Frame: 6 months
|
UL- E plane in millimeters LL- E plane in millimeters
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in airway
Time Frame: 6 months
|
difference in airway volume in cubic millimeters .
|
6 months
|
Changes in TMJ
Time Frame: 6 months
|
anterior, posterior, superior and medial joint space in cubic milimeters.
|
6 months
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malocclusion, Angle Class III
-
AL YousefKing Abdullah International Medical Research CenterUnknownMalocclusion, Angle Class I | Malocclusion; Angle Class II Division 1Saudi Arabia
-
State University of New York at BuffaloCompletedDental Malocclusion | Crowding, Tooth | Angle Class II | Angle Class IUnited States
-
Cairo UniversityUnknownClass III Malocclusion | Class II Malocclusion
-
Postgraduate Institute of Dental Sciences RohtakUnknownAngle Class II, Division 1 MalocclusionIndia
-
Future University in EgyptCompletedBimaxillary Protrusion | Class III Malocclusion | Crowding, Tooth | Class II MalocclusionEgypt
-
FCI SystemTerminatedMalocclusion, Angle Class II, Division 1France
-
Damascus UniversityCompletedClass III Malocclusion in Growing PatientsSyrian Arab Republic
-
mahmoud abdelhameed mohamedCompleted
-
Damascus UniversityCompletedAngle Class IISyrian Arab Republic
-
Postgraduate Institute of Dental Sciences RohtakCompleted
Clinical Trials on CS 2000
-
Milton S. Hershey Medical CenterCompletedOsteoarthritis, KneeUnited States
-
University of OxfordCompleted
-
Instituto Nacional de Psiquiatría Dr. Ramón de...Recruiting
-
Virginia Polytechnic Institute and State UniversityRecruiting
-
London School of Hygiene and Tropical MedicineMedical Research Council; University of OxfordCompleted
-
Eximis SurgicalTerminatedLaparoscopic Gynecological SurgeryUnited States
-
CorrectSequence Therapeutics Co., LtdFirst Affiliated Hospital of Guangxi Medical UniversityEnrolling by invitation
-
PATHUnited States Agency for International Development (USAID); Centers for Disease... and other collaboratorsCompletedMalariaUnited States, Mozambique
-
University of Illinois at ChicagoCompleted
-
Stryker GI Ltd.Unknown