ClassII Division 1 MalocclusionNCT04255511
Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
A study testing Twin Block and Fixed orthodontic appliance in people with ClassII Division 1 Malocclusion and Mandibular Retrognathism, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- ClassII Division 1 Malocclusion, Mandibular Retrognathism
- What is being tested?
- Twin Block and Fixed orthodontic appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2019to 1 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Skeletal class II division 1 malocclusion due to mandibular retrognathism.
- Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4.
- Overjet ≥ 6 mm.
- Patient in circumpubertal stage CVM2 and CVM3.
Who cannot join
- History of orthodontic treatment.
- Presence of craniofacial anomalies or TMJ disorders.
- Systemic problems that may affect craniofacial growth.
- Abnormal oral habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial
This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.
Read the detailed description
The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.
- Being tested
- Twin Block, Fixed orthodontic appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin BlockDevice
Functional appliance
Fixed orthodontic applianceDevice
Braces
| Study group | Role | What they receive |
|---|---|---|
| Twin block | Experimental | Removable Functional appliance Receives: Device: Twin Block |
| Fixed appliance | Active comparator | Preadjusted fixed appliance Receives: Device: Fixed orthodontic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharyngeal airway volume
CBCT images will be used to measure the pharyngeal airway volume in mm3
Measured: One year
Nocturnal breathing
Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.
Measured: One year
Secondary outcomes (3)
Maximum expiratory pressure
Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.
Measured: One year
Craniofacial changes
Lateral cephalometric images extracted from the CBCT images will be used to measure linear (mm) skeletal, dental and soft tissue changes of maxilla and mandible.
Measured: One year
Craniofacial changes
Lateral cephalometric images extracted from the CBCT images will be used to measure angular (º) skeletal, dental and soft tissue changes of maxilla and mandible.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start10 Dec 2019
- Primary completion10 Jun 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ClassII Division 1 MalocclusionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Montasser, Mansoura University
- Investigators
- Mona A Montasser, Phd, Study chair, Mansoura UniversityEman S Radwan, MSc, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255511
- Sponsor's protocol ID
- A09061119
- Status last verified
- Dec 2021
- First submitted
- 30 Jan 2020
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will be based on the facility regulations and approval.
Publications
Radwan ES, Maher A, Montasser MA. Effect of functional appliances on sleep-disordered breathing in Class II division 1 malocclusion children: Randomized controlled trial. Orthod Craniofac Res. 2024 Feb;27(1):126-138. doi: 10.1111/ocr.12696. Epub 2023 Jul 31.
PubMed 37522361
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04255511
- Acronym / sponsor ID
- A09061119
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 5 Feb 2020 (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.
This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.
Detailed description
The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Twin block | Experimental | Device: Twin BlockRemovable Functional appliance |
| Fixed appliance | Active comparator | Device: Fixed orthodontic appliancePreadjusted fixed appliance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Skeletal class II division 1 malocclusion due to mandibular retrognathism.
- Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4.
- Overjet ≥ 6 mm.
- Patient in circumpubertal stage CVM2 and CVM3.
Key exclusion criteria (4 listed)
- History of orthodontic treatment.
- Presence of craniofacial anomalies or TMJ disorders.
- Systemic problems that may affect craniofacial growth.
- Abnormal oral habits.
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 |
|---|---|---|
| Twin BlockFunctional appliance | Device | Twin block |
| Fixed orthodontic applianceBraces | Device | Fixed appliance |
Primary outcome
Pharyngeal airway volume
Time frame: One year
CBCT images will be used to measure the pharyngeal airway volume in mm3
Nocturnal breathing
Time frame: One year
Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.
3 secondary outcomes
Maximum expiratory pressure
Time frame: One year
Craniofacial changes
Time frame: One year
Craniofacial changes
Time frame: One year
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 7 Dec 2021.
- Derived from this study: PubMed 37522361Radwan ES, Maher A, Montasser MA. Effect of functional appliances on sleep-disordered breathing in Class II division 1 malocclusion children: Randomized controlled trial. Orthod Craniofac Res. 2024 Feb;27(1):126-138. doi: 10.1111/ocr.12696. Epub 2023 Jul 31.
- Individual participant dataSharing planned: Yes. Will be based on the facility regulations and approval.
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.
Mona A Montasser, Phd study chair
Mansoura University
Eman S Radwan, MSc principal investigator
Mansoura 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 Twin Block and Fixed orthodontic appliance in people with ClassII Division 1 Malocclusion and Mandibular Retrognathism, run by Mansoura 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 4 inclusion and 4 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 7 Dec 2021. 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?
Pharyngeal airway volume (time frame: One year). The study lists 2 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 NCT04255511, which also lists 1 linked publication.
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 7 Dec 2021.