Crowding, ToothNCT06516185
Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement
A study testing direct-printed aligner and thermoformed aligner in people with Crowding, Tooth and Tipped Tooth or Teeth, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crowding, Tooth, Tipped Tooth or Teeth, Rotation of Tooth
- What is being tested?
- direct-printed aligner and thermoformed aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2024to Jun 2026
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment
- Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries.
- No history of previous orthodontic treatment.
- Complete permanent dentition (excluding third molars, their presence or absence being irrelevant).
Who cannot join
- Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
Alejandro Iglesias-Linares contact
Spain1 site, 1 recruiting
- Recruiting
Complutense University of Madrid
Madrid, 28040
Alejandro Piñeda-Zayas, apined01@ucm.es
Alejandro Iglesias-Linares, aleigl01@ucm.es
About this study
Official title: Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.
The purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.
Read the detailed description
Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.
- Being tested
- direct-printed aligner, thermoformed aligner
- Keywords
- clear aligner therapy, direct-printed aligner, predictability, shape memory, stratification
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct-printed alignerDevice
Patients will be treated with direct-printed aligners until dental alignment is achieved.
thermoformed alignerDevice
Patients will be treated with thermoformed aligners until dental alignment is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Direct-printed aligner | Experimental | The experimental group will be treated with the aligner system fabricated by direct printing. The current protocols described in the literature and by the manufacturer for the fabrication of the printed orthodontic devices will be followed. Receives: Device: direct-printed aligner |
| Thermoformed aligner | Active comparator | The control group will be treated with the thermoformed or gold standard aligner system. The established protocols for treatment with thermoformed clear aligners will be followed. Receives: Device: thermoformed aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.
The primary outcome will be quantified through a continuous numerical variable, tooth movement efficiency or predictability (%) measured as the change between the final, intra-treatment and initial position for each of the individual movements studied, expressed as a percentage (%). The end of treatment or endpoint (E1) of this study will be established when the measurement of Little's Irregularity Index (hereafter LII) LII=0.
Measured: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries.
This will be assessed by quantifying the change between the predictability with auxiliaries and without auxiliaries for each of the individual movements studied respectively, expressed as a percentage (%).
Measured: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
Secondary outcomes (2)
PROMs of the patient undergoing direct-printed aligner treatment compared to the control group.
Participants will complete a validated pre-defined questionnaire [Patient-reported outcome measures (PROMs)] on treatment use and perceptions. The level of pain will be assessed using questionnaires.
Measured: These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months.
influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print.
This will be assessed by quantifying the change between the predictability, varying the degree of inclination of the aligner print, expressed as a percentage (%).
Measured: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start22 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crowding, ToothStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- This study is designed following CONSORT guidelines as a randomized equivalence clinical trial, controlled, with two parallel arms, and single-blind.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516185
- Sponsor's protocol ID
- 125-120324
- Other IDs
- 24/098-EC_P
- Status last verified
- Jun 2024
- First submitted
- 8 Jul 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Efficacy and Effectiveness of Two Types of Aligners Based on Stratification by Type of Movement.
- ClinicalTrials.gov ID
- NCT06516185
- Acronym / sponsor ID
- 125-120324
- Keywords
- clear aligner therapy, direct-printed aligner, predictability, shape memory, stratification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 Jul 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 purpose of this study is to evaluate the biomechanical behaviour of direct-printed and thermoformed aligners in different tooth movements, creating a biomechanical planning protocol based on a stratification of tooth movements according to the degree of predictability.
Detailed description
Once the objectives, benefits, risks and follow-up of the study have been explained to each eligible patient, patients will be asked to sign an informed consent form. They will also be informed that they may cancel their participation in the study at any time. Patient will be allocated randomly in two groups: The first group will receive orthodontic treatment with direct-printed aligner, while the second group will receive orthodontic treatment with conventional or gold standard thermoformed aligner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is designed following CONSORT guidelines as a randomized equivalence clinical trial, controlled, with two parallel arms, and single-blind.
| Arm | Type | Receives |
|---|---|---|
| Direct-printed aligner | Experimental | Device: direct-printed alignerThe experimental group will be treated with the aligner system fabricated by direct printing. The current protocols described in the literature and by the manufacturer for the fabrication of the printed orthodontic devices will be followed. |
| Thermoformed aligner | Active comparator | Device: thermoformed alignerThe control group will be treated with the thermoformed or gold standard aligner system. The established protocols for treatment with thermoformed clear aligners will be followed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with malocclusion and invididual dental malpositions requiring orthodontic treatment
- Adequate oral and periodontal health, with absence of periodontal disease, periapical infection or untreated caries.
- No history of previous orthodontic treatment.
- Complete permanent dentition (excluding third molars, their presence or absence being irrelevant).
Key exclusion criteria (2 listed)
- Altered bone metabolism (including use of antiresorptive, steroid or immunosuppressive drugs).
- Pregnant women.
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 |
|---|---|---|
| direct-printed alignerPatients will be treated with direct-printed aligners until dental alignment is achieved. | Device | Direct-printed aligner |
| thermoformed alignerPatients will be treated with thermoformed aligners until dental alignment is achieved. | Device | Thermoformed aligner |
Primary outcome
Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners.
Time frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
The primary outcome will be quantified through a continuous numerical variable, tooth movement efficiency or predictability (%) measured as the change between the final, intra-treatment and initial position for each of the individual movements studied, expressed as a percentage (%). The end of treatment or endpoint (E1) of this study will be established when the measurement of Little's Irregularity Index (hereafter LII) LII=0.
impact on the effectiveness and predictability of biomechanics auxiliaries compared to a control group in which movements are performed without the use of auxiliaries.
Time frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
This will be assessed by quantifying the change between the predictability with auxiliaries and without auxiliaries for each of the individual movements studied respectively, expressed as a percentage (%).
2 secondary outcomes
PROMs of the patient undergoing direct-printed aligner treatment compared to the control group.
Time frame: These should be completed five times after each visit (at 24 hours, 48 hours, 72 hours, 7 days and 14 days of aligner use) until reaching the defined endpoint (crowding resolution, LII=0), an average of 6 months.
influence on the printed orthodontic device (POD) of varying the degree of inclination of the aligner print.
Time frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Alejandro Iglesias-Linares contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct-printed aligner and thermoformed aligner in people with Crowding, Tooth and Tipped Tooth or Teeth, run by Universidad Complutense de Madrid at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 12 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Piñeda-Zayas (+34626923397, apined01@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictability for each type of tooth movement in patients with direct-printed aligners compared to a control group in which the movements are performed with thermoformed aligners. (time frame: Baseline and when the defined endpoint (crowding resolution, LII=0) is reached, an average of six months.). 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?
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 12 Dec 2024.