Malocclusion, Angle Class IIINCT04825951
Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients
A study testing CS 2000 in people with Malocclusion, Angle Class III, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class III
- What is being tested?
- CS 2000
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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˚).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Malocclusion, Angle Class III
- Being tested
- CS 2000
- Keywords
- Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS 2000Other
Also called Reversed Forsus Fatigue resistant appliance
treating growing Skeletal growing Class III patients
| Study group | Role | What they receive |
|---|---|---|
| CS 2000 appliance | Active comparator | treating growing skeletal Class III patients Receives: Other: CS 2000 |
| Reversed Forsus Fatigue resistant appliance | Active comparator | treating growing skeletal Class III patients Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal readings angles
SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
Measured: 6 months
Skeletal readings percetanges
LAFH in percentage
Measured: 6 months
Skeletal readings in millimeters
Wits appraisal in millimeters
Measured: 6 months
Dental readings angles
U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
Measured: 6 months
Dental readings in millimeters
U1-NA millimeters L1-NB in millimeters.
Measured: 6 months
Soft tissue readings in millimeters
UL- E plane in millimeters LL- E plane in millimeters
Measured: 6 months
Secondary outcomes (2)
Changes in airway
difference in airway volume in cubic millimeters .
Measured: 6 months
Changes in TMJ
anterior, posterior, superior and medial joint space in cubic milimeters.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 May 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIIStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial, parallel design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant Alaa, Alexandria University
- Investigators
- Bassant A Abbas, PHD resident, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825951
- Sponsor's protocol ID
- 070320212
- Status last verified
- Feb 2023
- First submitted
- 26 Mar 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: TREATMENT OF GROWING SKELETAL CLASS III PATIENTS
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.
PubMed 32005472World 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.
PubMed 11357217
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04825951
- Acronym / sponsor ID
- 070320212
- Conditions
- Malocclusion, Angle Class III
- Keywords
- Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled clinical trial, parallel design.
| Arm | Type | Receives |
|---|---|---|
| CS 2000 appliance | Active comparator | Other: CS 2000treating growing skeletal Class III patients |
| Reversed Forsus Fatigue resistant appliance | Active comparator | Other: CS 2000treating growing skeletal Class III patients |
| 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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS 2000Also: Reversed Forsus Fatigue resistant appliancetreating growing Skeletal growing Class III patients | Other | CS 2000 appliance, Reversed Forsus Fatigue resistant appliance |
Primary outcome
Skeletal readings angles
Time frame: 6 months
SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees
Skeletal readings percetanges
Time frame: 6 months
LAFH in percentage
Skeletal readings in millimeters
Time frame: 6 months
Wits appraisal in millimeters
Dental readings angles
Time frame: 6 months
U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees
Dental readings in millimeters
Time frame: 6 months
U1-NA millimeters L1-NB in millimeters.
Soft tissue readings in millimeters
Time frame: 6 months
UL- E plane in millimeters LL- E plane in millimeters
2 secondary outcomes
Changes in airway
Time frame: 6 months
Changes in TMJ
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 32005472Oliveira 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 publication: PubMed 11357217World 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.
- Individual participant dataSharing planned: No. TREATMENT OF GROWING SKELETAL CLASS III PATIENTS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassant A Abbas, PHD resident principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS 2000 in people with Malocclusion, Angle Class III, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal readings angles (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04825951, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.