Class II MalocclusionNCT06631131
Distalization With Aligners: Anchorage Options
A study testing Distalization with clear aligners supported by Class II elastics and Distalization with clear aligners supported by miniscrew in people with Class II Malocclusion and Class II Malocclusion, Division 1, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Background: To compare the dentoskeletal effects of Class II elastic anchorage and infrazygomatic crest (IZC) miniscrew anchorage in sequential maxillary molar distalization using clear aligners. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Class II Malocclusion, Class II Malocclusion, Division 1
- What is being tested?
- Distalization with clear aligners supported by Class II elastics and Distalization with clear aligners supported by miniscrew
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 26 Dec 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The inclusion criteria were as follows:
- Class II molar relationship,
- mild or moderate dental crowding on both arches,
- previous extraction or absence of the upper third molars,
- good compliance to orthodontic treatment,
- availability of initial and progress stereothography (STL) files of intraoral scans and lateral cephalometric radiographs.
Who cannot join
- severe dental crowding on both arches,
- Class II subdivision malocclusion,
- severe skeletal Class II malocclusion requiring orthognathic surgery,
- presence of impacted or supernumerary teeth,
- tooth extraction (except third molars),
- poor compliance to orthodontic treatment,
- craniofacial and dentofacial disorders, syndromes, or systemic diseases impacting bone metabolism or tooth movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization With Clear Aligners: Class II Elastic Anchorage vs. Miniscrew Anchorage
Background: To compare the dentoskeletal effects of Class II elastic anchorage and infrazygomatic crest (IZC) miniscrew anchorage in sequential maxillary molar distalization using clear aligners.
Methods: A total of 22 patients with Angle Class II malocclusion treated with clear aligners and maxillary molar distalization were included. Based on the anchorage method patients were divided into two groups: Class II elastics (Group 1) or IZC miniscrews (Group 2). Lateral cephalometric radiographs and digital models were obtained from all patients before treatment (T0) and after distalization of the second premolars (T1) to assess skeletal and dental changes. Geomagic Control X was used to superimpose the digital models.
Read the detailed description
The data for this study were obtained from patients who presented for treatment at the Department of Orthodontics at Bezmialem Vakif University Faculty of Dentistry. All patients were treated with clear aligners (Invisalign®, Align Technology, CA, USA) at Bezmialem University Hospital. Sequential distalization (50%) was planned in the maxillary arch. For each aligner, a staging of 0.25 mm was determined. Distalization starts with the second molars, then the first molars after half of the second molar movement is completed, and finally the premolars. In the ClinCheck planning, 3 or 4 mm vertical rectangular attachments were placed from the second molar to the canine and were bevelled mesially to enhance the distalization forces. The patients were divided into two groups, those who were treated with sequential distalization with aligners supported by Class II elastics (group 1) or IZC miniscrews (group 2). In group 1, with the beginning of the movement of the upper first molars, Class II intermaxillary elastics were used from precision cuts of the upper canines to the buttons on the lower first molars. In group 2, IZC miniscrews were inserted in the IZC region between the upper molars in both sides before first molar movement started. The same intramaxillary elastics were used from precision cuts of the upper canines to the IZC miniscrew. The use of intra/intermaxillary elastics was started with the initiation of upper first molar movement to prevent anchorage loss and maxillary incisor proclination. Both groups were instructed to wear the elastics and aligners a minimum of 22 hours per day using a 10-day aligner wear protocol. Maxillary third molars were extracted before treatment.
Patients were scanned by iTero 5D Element intraoral scanner and radiographs were taken before treatment (T0) and after distalization of the second premolar (T1).
Cephalometric radiographs were obtained from all patients and these radiographs were used for two-dimensional measurements.Digital tracing and measurements of the cephalometric radiographs were performed using NemoCeph version 6.0 software. Angular dental measurements were performed between the long axis of the teeth and the sella-nasion (S-N) plane using Image J software. The long axis was determined as a line through the incisal edge and the root apex for the incisors, through the buccal cusp tip and the root apex for the premolars, and through the centroid and the furcation for the molars. Digital models were exported from OrthoCAD software as stereolithography (STL) files and imported into Geomagic Control X software for three-dimensional (3D) model comparison. All digital models were superimposed using the local best fit algorithm. A reference area in the palatal region was used for the model superimposition and 50 iteration points were defined in this area for the superimpositions.
After model superimposition, reference points of the teeth were selected on the two models to enable linear measurements. These points were the mesiobuccal cusp tips of the maxillary molars and the buccal cusp tips of the premolars. These reference points were marked on the T0 and T1 models and measurements were taken to observe changes on all three axis. In linear measurements,
- X-axis represent buccolingual (transversal) differences (X+ in the buccal direction and X- in the palatal direction);
- Y-axis represent mesiodistal (sagittal) differences (Y+ in the distal direction and Y- in the mesial direction); and
- Z-axis represent vertical differences (Z+ indicating extrusion and Z- indicating intrusion).
For angular measurements, reference points and vectors were identified on 3D models. These points were the mesiobuccal and mesiopalatal cusp tips of the molars and the buccal and palatal cusp tips of the premolars. The angles between reference vectors were measured. Rotational movements were measured using the XY-axis, with positive values indicating mesiobuccal rotation and negative values indicating distobuccal rotation.
- Being tested
- Distalization with clear aligners supported by Class II elastics, Distalization with clear aligners supported by miniscrew
- Keywords
- Class II malocclusion, Clear aligners, Distalization, Miniscrew anchorage
- Medical subject headings
- Overbite, Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distalization with clear aligners supported by Class II elasticsDevice
Sequential distalization (50%) with clear aligners was planned in the maxillary arch for each patient. ). In group 1, with the beginning of the movement of the upper first molars, Class II intermaxillary elastics were used from precision cuts of the upper canines to the buttons on the lower first molars for supporting distalization movement.
Distalization with clear aligners supported by miniscrewDevice
Sequential distalization (50%) with clear aligners was planned in the maxillary arch for each patient. In group 2, IZC miniscrews were inserted in the IZC region between the upper molars in both sides before first molar movement started. The same intramaxillary elastics were used from precision cuts of the upper canines to the IZC miniscrew for supporting distalization movement.
| Study group | Role | What they receive |
|---|---|---|
| Distalization with clear aligners supported by Class II elastics | Active comparator | Group 1: these patients were treated with sequential distalization with aligners supported by Class II elastics. Receives: Device: Distalization with clear aligners supported by Class II elastics |
| Distalization with clear aligners supported by miniscrew | Active comparator | Group 2: these patients were treated with sequential distalization with aligners supported by IZC miniscrews. Receives: Device: Distalization with clear aligners supported by miniscrew |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization with Clear Aligners: Class II Elastic Anchorage vs. Miniscrew Anchorage
Lateral cephalometric radiographs and digital models were obtained from all patients before treatment and after distalization of the second premolars to assess skeletal and dental changes.
Digital tracing and measurements of the cephalometric radiographs were performed by the same investigator using NemoCeph software. Angular dental measurements were performed between the long axis of the teeth and the sella-nasion (S-N) plane using Image J software.
Geomagic Control X was used to superimpose the digital models and measurement of dental movements.
Measured: Patients were collected and treatmets were started up to 9 months. At 12 weeks, miniscrews were inserted in group 2 and elastics were started to be used in each group. Final data were collected up to 20 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Dec 2021
- Primary completion30 Aug 2023
- Study completion26 Dec 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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of twenty-seven patients were initially included. However, five patients were excluded because they discontinued treatment (n=2), had poor treatment compliance (n=2), or had poor radiograph quality (n=1). Consequently, the final sample comprised 22 individuals, with 11 individuals (22 second molar, 22 first molar and 22 second premolar) in each group, ranging in age from 15 to 25. All patients were treated with clear aligners.The patients were divided into two groups, those who were treated with sequential distalization with aligners supported by Class II elastics (group 1) or IZC miniscrews (group 2).
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezgi Sunal Aktürk, Assistant professor, Study director, University of Health Sciences, Hamidiye Faculty of Dental Medicine, Department of OrthodonticsEzgi Kösen, PhD student, Principal investigator, Bezmialem Vakif University,Institute of Health Sciences, Department of Orthodontics,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631131
- Sponsor's protocol ID
- 40173
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data of this study belong to the PhD thesis and the thesis has not yet been defended.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization With Clear Aligners: Class II Elastic Anchorage vs. Miniscrew Anchorage
- ClinicalTrials.gov ID
- NCT06631131
- Acronym / sponsor ID
- 40173
- Keywords
- Class II malocclusion, Clear aligners, Distalization, Miniscrew anchorage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 8 Oct 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.
Background: To compare the dentoskeletal effects of Class II elastic anchorage and infrazygomatic crest (IZC) miniscrew anchorage in sequential maxillary molar distalization using clear aligners.
Methods: A total of 22 patients with Angle Class II malocclusion treated with clear aligners and maxillary molar distalization were included. Based on the anchorage method patients were divided into two groups: Class II elastics (Group 1) or IZC miniscrews (Group 2). Lateral cephalometric radiographs and digital models were obtained from all patients before treatment (T0) and after distalization of the second premolars (T1) to assess skeletal and dental changes. Geomagic Control X was used to superimpose the digital models.
Detailed description
The data for this study were obtained from patients who presented for treatment at the Department of Orthodontics at Bezmialem Vakif University Faculty of Dentistry. All patients were treated with clear aligners (Invisalign®, Align Technology, CA, USA) at Bezmialem University Hospital. Sequential distalization (50%) was planned in the maxillary arch. For each aligner, a staging of 0.25 mm was determined. Distalization starts with the second molars, then the first molars after half of the second molar movement is completed, and finally the premolars. In the ClinCheck planning, 3 or 4 mm vertical rectangular attachments were placed from the second molar to the canine and were bevelled mesially to enhance the distalization forces. The patients were divided into two groups, those who were treated with sequential distalization with aligners supported by Class II elastics (group 1) or IZC miniscrews (group 2). In group 1, with the beginning of the movement of the upper first molars, Class II intermaxillary elastics were used from precision cuts of the upper canines to the buttons on the lower first molars. In group 2, IZC miniscrews were inserted in the IZC region between the upper molars in both sides before first molar movement started. The same intramaxillary elastics were used from precision cuts of the upper canines to the IZC miniscrew. The use of intra/intermaxillary elastics was started with the initiation of upper first molar movement to prevent anchorage loss and maxillary incisor proclination. Both groups were instructed to wear the elastics and aligners a minimum of 22 hours per day using a 10-day aligner wear protocol. Maxillary third molars were extracted before treatment.
Patients were scanned by iTero 5D Element intraoral scanner and radiographs were taken before treatment (T0) and after distalization of the second premolar (T1).
Cephalometric radiographs were obtained from all patients and these radiographs were used for two-dimensional measurements.Digital tracing and measurements of the cephalometric radiographs were performed using NemoCeph version 6.0 software. Angular dental measurements were performed between the long axis of the teeth and the sella-nasion (S-N) plane using Image J software. The long axis was determined as a line through the incisal edge and the root apex for the incisors, through the buccal cusp tip and the root apex for the premolars, and through the centroid and the furcation for the molars. Digital models were exported from OrthoCAD software as stereolithography (STL) files and imported into Geomagic Control X software for three-dimensional (3D) model comparison. All digital models were superimposed using the local best fit algorithm. A reference area in the palatal region was used for the model superimposition and 50 iteration points were defined in this area for the superimpositions.
After model superimposition, reference points of the teeth were selected on the two models to enable linear measurements. These points were the mesiobuccal cusp tips of the maxillary molars and the buccal cusp tips of the premolars. These reference points were marked on the T0 and T1 models and measurements were taken to observe changes on all three axis. In linear measurements,
- X-axis represent buccolingual (transversal) differences (X+ in the buccal direction and X- in the palatal direction);
- Y-axis represent mesiodistal (sagittal) differences (Y+ in the distal direction and Y- in the mesial direction); and
- Z-axis represent vertical differences (Z+ indicating extrusion and Z- indicating intrusion).
For angular measurements, reference points and vectors were identified on 3D models. These points were the mesiobuccal and mesiopalatal cusp tips of the molars and the buccal and palatal cusp tips of the premolars. The angles between reference vectors were measured. Rotational movements were measured using the XY-axis, with positive values indicating mesiobuccal rotation and negative values indicating distobuccal rotation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of twenty-seven patients were initially included. However, five patients were excluded because they discontinued treatment (n=2), had poor treatment compliance (n=2), or had poor radiograph quality (n=1). Consequently, the final sample comprised 22 individuals, with 11 individuals (22 second molar, 22 first molar and 22 second premolar) in each group, ranging in age from 15 to 25. All patients were treated with clear aligners.The patients were divided into two groups, those who were treated with sequential distalization with aligners supported by Class II elastics (group 1) or IZC miniscrews (group 2).
| Arm | Type | Receives |
|---|---|---|
| Distalization with clear aligners supported by Class II elastics | Active comparator | Device: Distalization with clear aligners supported by Class II elasticsGroup 1: these patients were treated with sequential distalization with aligners supported by Class II elastics. |
| Distalization with clear aligners supported by miniscrew | Active comparator | Device: Distalization with clear aligners supported by miniscrewGroup 2: these patients were treated with sequential distalization with aligners supported by IZC miniscrews. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Class II molar relationship,
- mild or moderate dental crowding on both arches,
- previous extraction or absence of the upper third molars,
- good compliance to orthodontic treatment,
- availability of initial and progress stereothography (STL) files of intraoral scans and lateral cephalometric radiographs.
Key exclusion criteria (7 listed)
- severe dental crowding on both arches,
- Class II subdivision malocclusion,
- severe skeletal Class II malocclusion requiring orthognathic surgery,
- presence of impacted or supernumerary teeth,
- tooth extraction (except third molars),
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 |
|---|---|---|
| Distalization with clear aligners supported by Class II elasticsSequential distalization (50%) with clear aligners was planned in the maxillary arch for each patient. ). In group 1, with the beginning of the movement of the upper first molars, Class II intermaxillary elastics were used from precision cuts of the upper canines to the buttons on the lower first molars for supporting distalization movement. | Device | Distalization with clear aligners supported by Class II elastics |
| Distalization with clear aligners supported by miniscrewSequential distalization (50%) with clear aligners was planned in the maxillary arch for each patient. In group 2, IZC miniscrews were inserted in the IZC region between the upper molars in both sides before first molar movement started. The same intramaxillary elastics were used from precision cuts of the upper canines to the IZC miniscrew for supporting distalization movement. | Device | Distalization with clear aligners supported by miniscrew |
Primary outcome
Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization with Clear Aligners: Class II Elastic Anchorage vs. Miniscrew Anchorage
Time frame: Patients were collected and treatmets were started up to 9 months. At 12 weeks, miniscrews were inserted in group 2 and elastics were started to be used in each group. Final data were collected up to 20 months.
Lateral cephalometric radiographs and digital models were obtained from all patients before treatment and after distalization of the second premolars to assess skeletal and dental changes. Digital tracing and measurements of the cephalometric radiographs were performed by the same investigator using NemoCeph software. Angular dental measurements were performed between the long axis of the teeth and the sella-nasion (S-N) plane using Image J software. Geomagic Control X was used to superimpose the digital models and measurement of dental movements.
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 5 Feb 2025.
- Individual participant dataSharing planned: No. The data of this study belong to the PhD thesis and the thesis has not yet been defended.
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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.
Ezgi Sunal Aktürk, Assistant professor study director
University of Health Sciences, Hamidiye Faculty of Dental Medicine, Department of Orthodontics
Ezgi Kösen, PhD student principal investigator
Bezmialem Vakif University,Institute of Health Sciences, Department of Orthodontics,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distalization with clear aligners supported by Class II elastics and Distalization with clear aligners supported by miniscrew in people with Class II Malocclusion and Class II Malocclusion, Division 1, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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 5 Feb 2025. 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 Turkey (Türkiye). 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?
Evaluation of the Dentoskeletal Effects of Maxillary Molar Distalization with Clear Aligners: Class II Elastic Anchorage vs. Miniscrew Anchorage (time frame: Patients were collected and treatmets were started up to 9 months. At 12 weeks, miniscrews were inserted in group 2 and elastics were started to be used in each group. Final data were collected up to 20 months.). 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 5 Feb 2025.