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Enrolling by invitationNCT06050655Updated Oct 18, 2024

The Efficacy of Lingual Aligners in Adults.

An interventional study of Lingual aligners in Malocclusion, Angle Class I, sponsored by University Hospital, Geneva. Enrolling by invitation at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-18.

Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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
02

Conditions studied

  • Malocclusion, Angle Class I
03

In context

Malocclusion, Angle Class I

35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.

This study's planned enrollment of 20 is below the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.

Browse Malocclusion, Angle Class I studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults older than 18 years old
  • About to undergo orthodontic treatment

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Adults with Angle Class I malocclusion

    * Adults older than 18 years old * About to undergo orthodontic treatment

    Device: Lingual aligners

Interventions

  • DeviceLingual aligners

    orthodontic treatment with lingual aligners

06

What researchers measure

Primary outcomes

  1. Tooth movement

    Tooth movement in the three planes of space measured millimetrically and with degrees, depending on the type of tooth movement

    Time frame: At the end of study completion, an average of 10 months.

Secondary outcomes

  1. Patient discomfort / pain

    Rate of Patient discomfort using the visual assessment scale

    Time frame: Each patient visit, through study completion, an average of 10 months

  2. Appliance defects

    Rate of Breakage or cracking of the aligners

    Time frame: Each patient visit, through study completion, an average of 10 months

  3. Patient compliance

    Indice of Patient compliance evaluated with a questionnaire

    Time frame: Each patient visit, through study completion, an average of 10 months

  4. 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

    Time frame: Each patient visit, through study completion, an average of 10 months .

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Primary participant data will only be shared with other researchers upon reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06050655
Responsible party
Fabiana Mutzenberg (Principal investigator, University Hospital, Geneva) — Principal investigator
First posted
Sep 22, 2023
Start date
Sep 19, 2024
Primary completion
Feb 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Oct 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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