Class II MalocclusionNCT06209125
Evaluation of Skeletal and Dental Effect of the New Hybrid Aesthetic Functional Appliance
A study testing hybrid aesthetic functional appliance in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- hybrid aesthetic functional appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 8 May 2023
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age included is the mixed dentition stage ( 6 -12 y )
- skeletal Class II division 1.
- Overjet more than 4 mm.
Who cannot join
- Previous orthodontic treatment.
- Bad oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Correction of Skeletal Class II Division I by the Hybrid Aesthetic Functional Appliances
use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion.
Read the detailed description
The Sample:
The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
A sample size of 16 data pairs achieves 80.3% power to reject the null hypothesis of zero effect size when the population effect size is 1.00 and the significance level (alpha) is 0.050 using a two-sided paired t-test.
The ten patients will be selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Mansoura University.
The parents of each patient will be informed regarding the study and will sign written consent before starting the treatment.
Records:
- Photographs:
- Extra-oral (frontal -lateral -frontal with a smile).
- Intra-oral (frontal -lateral - occlusal).
- Radiographs:
- Cephalometric.
- Panorama.
- Hand wrist radiographs.
- Upper and lower orthodontic casts.
Appliance construction:
- After taking the upper and lower impressions; a construction wax bite will be done, and the mandible will be positioned anteriorly to achieve an edge-to-edge relationship parallel to the functional occlusal plane. Single-step advancement of the mandible will be achieved If the overjet ranges between (3-4 mm) or segmental advancement if it is larger than 5 mm using the Exactobite.
- HAF appliance will be constructed It is of double plate design, consisting of thermoplastic and acrylic parts The upper component is a vacuum-formed plate, made of transparent hard-elastic polyethylene sheet with 2 mm thickness, equipped with an acrylic advancement bar positioned in the anterior midpalatal region.
Similarly, the lower plate is constructed by thermoplastic material of the same width covering the six anterior teeth.
An acrylic guidance surface is placed over the plastic coverage on the lingual surfaces of lower incisors and canines, aimed to fit the upper bar.
Two-sided arms are extended from the acrylic resin body up to second molars adapted to the morphology of the lingual vestibule.
To obtain optimal shape matching of the opposing attachments, the working casts are mounted on a semi-adjustable articulator to contact in an end-to-end relationship.
Posterior teeth are intentionally exposed to facilitate eruption and leveling of a deep curve of Spee.
White-colored acrylic resin is used for the fabrication of acrylic parts to enhance esthetics.
Using a special plier, buttons are formed at the cervical third of upper and lower dental midlines to enable night-time wear of vertical elastics, or light-cured composite resin combined with appropriate transparent matrices can be used for button construction.
- The patients will be instructed to:
- use the HAF appliance for 12-14 hours per day.
- Maintain good oral hygiene, and brush your teeth after each meal.
- Attain an orthodontic clinic every three weeks.
- Use elastics at night.
- When the overjet is corrected; the upper part is served shortly as the anterior bite plane.
- Conditions
- Class II Malocclusion
- Being tested
- hybrid aesthetic functional appliance
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid aesthetic functional applianceDevice
treatment of class II division one malocclusion
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | use new device for treatment of class II malocclusion Receives: Device: hybrid aesthetic functional appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)
early treatment of class II division 1 malocclusion using HAF appliance and evaluate the skeletal and dental effect of new appliance by take cephalogram before and after treatments
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 posted17 Jan 2024
- Study start1 Feb 2022
- Primary completion2 Mar 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohaila Adnan, Mansoura University
- Investigators
- sohaila ad ahmed, master, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209125
- Sponsor's protocol ID
- sohaila
- Other IDs
- IRB approval number
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Correction of Skeletal Class II Division I by the Hybrid Aesthetic Functional Appliances
- ClinicalTrials.gov ID
- NCT06209125
- Acronym / sponsor ID
- sohaila
- Conditions
- Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 17 Jan 2024 (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.
use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion.
Detailed description
The Sample:
The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.
A sample size of 16 data pairs achieves 80.3% power to reject the null hypothesis of zero effect size when the population effect size is 1.00 and the significance level (alpha) is 0.050 using a two-sided paired t-test.
The ten patients will be selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Mansoura University.
The parents of each patient will be informed regarding the study and will sign written consent before starting the treatment.
Records:
- Photographs:
- Extra-oral (frontal -lateral -frontal with a smile).
- Intra-oral (frontal -lateral - occlusal).
- Radiographs:
- Cephalometric.
- Panorama.
- Hand wrist radiographs.
- Upper and lower orthodontic casts.
Appliance construction:
- After taking the upper and lower impressions; a construction wax bite will be done, and the mandible will be positioned anteriorly to achieve an edge-to-edge relationship parallel to the functional occlusal plane. Single-step advancement of the mandible will be achieved If the overjet ranges between (3-4 mm) or segmental advancement if it is larger than 5 mm using the Exactobite.
- HAF appliance will be constructed It is of double plate design, consisting of thermoplastic and acrylic parts The upper component is a vacuum-formed plate, made of transparent hard-elastic polyethylene sheet with 2 mm thickness, equipped with an acrylic advancement bar positioned in the anterior midpalatal region.
Similarly, the lower plate is constructed by thermoplastic material of the same width covering the six anterior teeth.
An acrylic guidance surface is placed over the plastic coverage on the lingual surfaces of lower incisors and canines, aimed to fit the upper bar.
Two-sided arms are extended from the acrylic resin body up to second molars adapted to the morphology of the lingual vestibule.
To obtain optimal shape matching of the opposing attachments, the working casts are mounted on a semi-adjustable articulator to contact in an end-to-end relationship.
Posterior teeth are intentionally exposed to facilitate eruption and leveling of a deep curve of Spee.
White-colored acrylic resin is used for the fabrication of acrylic parts to enhance esthetics.
Using a special plier, buttons are formed at the cervical third of upper and lower dental midlines to enable night-time wear of vertical elastics, or light-cured composite resin combined with appropriate transparent matrices can be used for button construction.
- The patients will be instructed to:
- use the HAF appliance for 12-14 hours per day.
- Maintain good oral hygiene, and brush your teeth after each meal.
- Attain an orthodontic clinic every three weeks.
- Use elastics at night.
- When the overjet is corrected; the upper part is served shortly as the anterior bite plane.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Device: hybrid aesthetic functional applianceuse new device for treatment of class II malocclusion |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age included is the mixed dentition stage ( 6 -12 y )
- skeletal Class II division 1.
- Overjet more than 4 mm.
Key exclusion criteria (2 listed)
- Previous orthodontic treatment.
- Bad oral hygiene.
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 |
|---|---|---|
| hybrid aesthetic functional appliancetreatment of class II division one malocclusion | Device | study group |
Primary outcome
Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)
Time frame: one year
early treatment of class II division 1 malocclusion using HAF appliance and evaluate the skeletal and dental effect of new appliance by take cephalogram before and after treatments
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 22 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Class II Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
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.
sohaila ad ahmed, master 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 hybrid aesthetic functional appliance in people with Class II Malocclusion, 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 3 inclusion and 2 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 22 Jan 2024. 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?
Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.