Class II Malocclusion(AMDA)NCT06726694
Class II Malocclusion Correction Using the Mini-screw Supported Advanced Molar Distalization Appliance
A study testing class II molar relation correction by advanced molar distalization appliance in people with Class II Malocclusion, run by Ain Shams University at 1 site in Egypt.
Trial summary
the primary aim for this clinical trial was to assess the amount of molar distalization The subjects with the following inclusion criteria: 1. Early permanent dention. 2. Class II division 1 or class II division 2 dental occlusion. 3. Good oral hygiene. 4. No previous orthodontic treatment. 5. Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- class II molar relation correction by advanced molar distalization appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2020to 1 Jul 2022
- 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 11 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Patients with severe crowding requiring extraction.
- Vertical growth patterns.
- Syndromic patients.
- Vulnerable groups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Skeletal, Dental and Soft Tissue Changes in Class II Malocclusion Correction Using the Mini-screw Supported Advanced Molar Distalization Appliance
the primary aim for this clinical trial was to assess the amount of molar distalization
The subjects with the following inclusion criteria:
- Early permanent dention.
- Class II division 1 or class II division 2 dental occlusion.
- Good oral hygiene.
- No previous orthodontic treatment.
- No history of serious medical problems such as diabetes or autoimmune disease, allergies or bone disease.
- Good periodontal support of the upper molar.
Read the detailed description
Study procedure:
An informed consent was signed by the patients before their enrolment in the current study in which the aim of the study, the methodology and possible complications was clearly described. This research was reviewed by Research Ethics Committee, Faculty of Dentistry, Ain Shams University.
Full orthodontic records were taken for patients who meet the inclusion criteria. These records are:
- Extra-oral and intra-oral photographs.
- Orthodontic study cast before after distalization.
- Panoramic radiograph.
- Lateral cephalometric radiograph.
Procedure:
- Bands on first molars are fitted with lingual sheaths.
- Impression with bands in place is taken and poured into stone model.
- Positioning the appliance on the model by inserting the palatal extension in the lingual sheaths of the molar bands, where the arch wire should be apical and parallel to the occlusal plane. The width of the horseshoe type palatal arch wire is adjusted to fit palatal width.
- The mesial stop screws are moved distally to fully compressed the coil spring encased in the tubing system and the distal stop screws are screwed in place to stabilize the tubing system on the archwire.
- The final length of the palatal archwire is determined by marking its distal end with a pencil, leaving approximately 8-10mm extended out of the distal screw.
- Remove the appliance and cut off the distal end at the mark and bend or loop is formed on each distal end to act as mechanical stop to prevent any distalization beyond this point and to avoid any tissue irritation. Alternatively, or in addition, a small amount of light cured resin can be added to the end to ensure that the molar cannot slip out of the wire.
- The appliance is disinfected and inserted into the patient mouth, ensuring that it parallel to the occlusal plane and the two symmetrical loops are posterior to the incisive foramen.
- The wire extensions welded on the tubing system are inserted into the lingual sheath of the molar band and secured in position with SS ligature wire.
- The palatal is rinsed with a 0.02% chlorohexidine solution.
- Small amount of local anaesthesia is applied to the soft tissue of the palatal.
- 2 miniscrews implants are inserted through the two symmetrical closed loops of the horseshoe type palatal arch wire using especial screwdriver at the paramedian region of the palate.
- A small portion of light-cure resin can be added to cover the top of each implant head plus the ending of the ligature wires and the loops of the palatal arch wire to avoid plaque accumulation.
- Activation of the AMDA by unscrewing the distal screws to allow free distal sliding of the posterior part of the tubing system, the mesial stop screws are not altered.
- Following initial activation of the AMDA, the patient is monitored at 4-week intervals and reactivation is done when force decreases until Class I molar relationship is obtained
Adverse event reporting:
- acceptable discomfort and mild to moderate pain.
Methods of assessment:
- The rate of tooth movement was analyzed using computer software on digital models obtained by scanning orthodontic study casts taken before and after molar distalization. When a Class I molar relationship is obtained distalization will be considered complete, this was assessed visually.
- Lateral cephalometric radiograph was obtained before and after molar distalization for all participants.
- All data was tabulated and statistically analyzed.
- Conditions
- Class II Malocclusion
- Being tested
- class II molar relation correction by advanced molar distalization appliance
- Keywords
- Disatlization, class II, growing patient, molar tipping
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
class II molar relation correction by advanced molar distalization applianceDevice
Also called AMDA, miniscrews supported distalizer
correction of class II molar relation by a novel miniscrews distalizer
| Study group | Role | What they receive |
|---|---|---|
| class II malocclusion patients | Active comparator | class II molar relation correction by advanced maxillary molar distalization appliance Receives: Device: class II molar relation correction by advanced molar distalization appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of molar distalization
measuring the amount of molar distalization in millimeter by cephalometric analysis
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start20 May 2020
- Primary completion1 May 2022
- Study completion1 Jul 2022
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 Class II MalocclusionStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726694
- Sponsor's protocol ID
- Distalization
- Acronym
- (AMDA)
- Status last verified
- May 2020
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: inclusion criteria study procedures conclusions
Publications
Papadopoulos MA. Efficient Distalization of Maxillary Molars with Temporary Anchorage Devices for the Treatment of Class II Malocclusion. Turk J Orthod. 2020 Aug 20;33(3):197-201. doi: 10.5152/TurkJOrthod.2020.20064. eCollection 2020 Sep.
PubMed 32974067
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skeletal, Dental and Soft Tissue Changes in Class II Malocclusion Correction Using the Mini-screw Supported Advanced Molar Distalization Appliance
- ClinicalTrials.gov ID
- NCT06726694
- Acronym / sponsor ID
- (AMDA) / Distalization
- Conditions
- Class II Malocclusion
- Keywords
- Disatlization, class II, growing patient, molar tipping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 10 Dec 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.
the primary aim for this clinical trial was to assess the amount of molar distalization
The subjects with the following inclusion criteria:
- Early permanent dention.
- Class II division 1 or class II division 2 dental occlusion.
- Good oral hygiene.
- No previous orthodontic treatment.
- No history of serious medical problems such as diabetes or autoimmune disease, allergies or bone disease.
- Good periodontal support of the upper molar.
Detailed description
Study procedure:
An informed consent was signed by the patients before their enrolment in the current study in which the aim of the study, the methodology and possible complications was clearly described. This research was reviewed by Research Ethics Committee, Faculty of Dentistry, Ain Shams University.
Full orthodontic records were taken for patients who meet the inclusion criteria. These records are:
- Extra-oral and intra-oral photographs.
- Orthodontic study cast before after distalization.
- Panoramic radiograph.
- Lateral cephalometric radiograph.
Procedure:
- Bands on first molars are fitted with lingual sheaths.
- Impression with bands in place is taken and poured into stone model.
- Positioning the appliance on the model by inserting the palatal extension in the lingual sheaths of the molar bands, where the arch wire should be apical and parallel to the occlusal plane. The width of the horseshoe type palatal arch wire is adjusted to fit palatal width.
- The mesial stop screws are moved distally to fully compressed the coil spring encased in the tubing system and the distal stop screws are screwed in place to stabilize the tubing system on the archwire.
- The final length of the palatal archwire is determined by marking its distal end with a pencil, leaving approximately 8-10mm extended out of the distal screw.
- Remove the appliance and cut off the distal end at the mark and bend or loop is formed on each distal end to act as mechanical stop to prevent any distalization beyond this point and to avoid any tissue irritation. Alternatively, or in addition, a small amount of light cured resin can be added to the end to ensure that the molar cannot slip out of the wire.
- The appliance is disinfected and inserted into the patient mouth, ensuring that it parallel to the occlusal plane and the two symmetrical loops are posterior to the incisive foramen.
- The wire extensions welded on the tubing system are inserted into the lingual sheath of the molar band and secured in position with SS ligature wire.
- The palatal is rinsed with a 0.02% chlorohexidine solution.
- Small amount of local anaesthesia is applied to the soft tissue of the palatal.
- 2 miniscrews implants are inserted through the two symmetrical closed loops of the horseshoe type palatal arch wire using especial screwdriver at the paramedian region of the palate.
- A small portion of light-cure resin can be added to cover the top of each implant head plus the ending of the ligature wires and the loops of the palatal arch wire to avoid plaque accumulation.
- Activation of the AMDA by unscrewing the distal screws to allow free distal sliding of the posterior part of the tubing system, the mesial stop screws are not altered.
- Following initial activation of the AMDA, the patient is monitored at 4-week intervals and reactivation is done when force decreases until Class I molar relationship is obtained
Adverse event reporting:
- acceptable discomfort and mild to moderate pain.
Methods of assessment:
- The rate of tooth movement was analyzed using computer software on digital models obtained by scanning orthodontic study casts taken before and after molar distalization. When a Class I molar relationship is obtained distalization will be considered complete, this was assessed visually.
- Lateral cephalometric radiograph was obtained before and after molar distalization for all participants.
- All data was tabulated and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| class II malocclusion patients | Active comparator | Device: class II molar relation correction by advanced molar distalization applianceclass II molar relation correction by advanced maxillary molar distalization appliance |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patients with severe crowding requiring extraction.
- Vertical growth patterns.
- Syndromic patients.
- Vulnerable groups.
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 |
|---|---|---|
| class II molar relation correction by advanced molar distalization applianceAlso: AMDA, miniscrews supported distalizercorrection of class II molar relation by a novel miniscrews distalizer | Device | class II malocclusion patients |
Primary outcome
amount of molar distalization
Time frame: 8 months
measuring the amount of molar distalization in millimeter by cephalometric analysis
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 10 Dec 2024.
- Background: PubMed 32974067Papadopoulos MA. Efficient Distalization of Maxillary Molars with Temporary Anchorage Devices for the Treatment of Class II Malocclusion. Turk J Orthod. 2020 Aug 20;33(3):197-201. doi: 10.5152/TurkJOrthod.2020.20064. eCollection 2020 Sep.
- Individual participant dataSharing planned: Yes. inclusion criteria study procedures conclusions
Related trials for Class II 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
Recruiting
Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates
Malocclusion, Angle Class II
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing class II molar relation correction by advanced molar distalization appliance in people with Class II Malocclusion, run by Ain Shams 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 0 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 10 Dec 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?
amount of molar distalization (time frame: 8 months). 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 NCT06726694, 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 10 Dec 2024.