Malocclusion, Angle Class INCT06050655
The Efficacy of Lingual Aligners in Adults.
A study testing Lingual aligners in people with Malocclusion, Angle Class I, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to test the effectiveness of lingual aligners in adults. The main question to answer is: Are lingual aligners effective in achieving desired and predicted tooth movements? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class I
- What is being tested?
- Lingual aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Sep 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults older than 18 years old
- About to undergo orthodontic treatment
Who cannot join
- Patients with tooth extractions or tooth agenesis with space closure
- Patients with surface enamel defects
- Pregnant patients
- Syndromic patients or those with cleft lip and/or palate
- Patients with metabolic diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Lingual Aligners in Adults: a Pilot Study.
The goal of this clinical trial is to test the effectiveness of lingual aligners in adults.
The main question to answer is:
- Are lingual aligners effective in achieving desired and predicted tooth movements?
Read the detailed description
The aim of this pilot study is to assess the effectiveness and the accuracy of lingual aligners by evaluating the discrepancy between the predicted and the achieved amounts of tooth movements.
Also:
- Patient discomfort and pain
- Appliance defects
- Patient compliance
- Chair and treatment time
Key inclusion criteria:
- Adults older than 18 years old
- About to undergo orthodontic treatment
Key exclusion criteria:
- Patients with tooth extractions or tooth agenesis with space closure
- Patients with surface enamel defects
- Pregnant patients
- Syndromic patients or those with cleft lip and/or palate
- Patients with metabolic diseases
- Conditions
- Malocclusion, Angle Class I
- Being tested
- Lingual aligners
- Medical subject headings
- Malocclusion, Angle Class I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual alignersDevice
orthodontic treatment with lingual aligners
| Study group | Role | What they receive |
|---|---|---|
| Adults with Angle Class I malocclusion | Experimental | * Adults older than 18 years old
* About to undergo orthodontic treatment Receives: Device: Lingual aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth movement
Tooth movement in the three planes of space measured millimetrically and with degrees, depending on the type of tooth movement
Measured: At the end of study completion, an average of 10 months.
Secondary outcomes (4)
Patient discomfort / pain
Rate of Patient discomfort using the visual assessment scale
Measured: Each patient visit, through study completion, an average of 10 months
Appliance defects
Rate of Breakage or cracking of the aligners
Measured: Each patient visit, through study completion, an average of 10 months
Patient compliance
Indice of Patient compliance evaluated with a questionnaire
Measured: Each patient visit, through study completion, an average of 10 months
Chair and treatment time
The amount of time the patient spends on the dental chair at each visit measured in minutes; and treatment length in months
Measured: Each patient visit, through study completion, an average of 10 months .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start19 Sep 2024
- Primary completionFeb 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiana Mutzenberg, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050655
- Sponsor's protocol ID
- 2023-D0045
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Primary participant data will only be shared with other researchers upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lingual Aligners in Adults: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06050655
- Acronym / sponsor ID
- 2023-D0045
- Conditions
- Malocclusion, Angle Class I
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 22 Sep 2023 (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 goal of this clinical trial is to test the effectiveness of lingual aligners in adults.
The main question to answer is:
- Are lingual aligners effective in achieving desired and predicted tooth movements?
Detailed description
The aim of this pilot study is to assess the effectiveness and the accuracy of lingual aligners by evaluating the discrepancy between the predicted and the achieved amounts of tooth movements.
Also:
- Patient discomfort and pain
- Appliance defects
- Patient compliance
- Chair and treatment time
Key inclusion criteria:
- Adults older than 18 years old
- About to undergo orthodontic treatment
Key exclusion criteria:
- Patients with tooth extractions or tooth agenesis with space closure
- Patients with surface enamel defects
- Pregnant patients
- Syndromic patients or those with cleft lip and/or palate
- Patients with metabolic diseases
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with Angle Class I malocclusion | Experimental | Device: Lingual aligners* Adults older than 18 years old * About to undergo orthodontic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults older than 18 years old
- About to undergo orthodontic treatment
Key exclusion criteria (5 listed)
- Patients with tooth extractions or tooth agenesis with space closure
- Patients with surface enamel defects
- Pregnant patients
- Syndromic patients or those with cleft lip and/or palate
- Patients with metabolic diseases
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 |
|---|---|---|
| Lingual alignersorthodontic treatment with lingual aligners | Device | Adults with Angle Class I malocclusion |
Primary outcome
Tooth movement
Time frame: At the end of study completion, an average of 10 months.
Tooth movement in the three planes of space measured millimetrically and with degrees, depending on the type of tooth movement
4 secondary outcomes
Patient discomfort / pain
Time frame: Each patient visit, through study completion, an average of 10 months
Appliance defects
Time frame: Each patient visit, through study completion, an average of 10 months
Patient compliance
Time frame: Each patient visit, through study completion, an average of 10 months
Chair and treatment time
Time frame: Each patient visit, through study completion, an average of 10 months .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No. Primary participant data will only be shared with other researchers upon reasonable request
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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.
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 Lingual aligners in people with Malocclusion, Angle Class I, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 18 Oct 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tooth movement (time frame: At the end of study completion, an average of 10 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 18 Oct 2024; AzTrials last refreshed its copy on 26 Oct 2026.