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OpenTrials
Enrolling by Invitation

NCT Number: NCT06050655

The Efficacy of Lingual Aligners in Adults.

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?

Enrolling by Invitation

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Key information

Conditions

Malocclusion, Angle Class I Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Lingual aligners

Device

orthodontic treatment with lingual aligners

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient discomfort / pain

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

    Rate of Patient discomfort using the visual assessment scale

  2. Appliance defects

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

    Rate of Breakage or cracking of the aligners

  3. Patient compliance

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

    Indice of Patient compliance evaluated with a questionnaire

  4. Chair and treatment time

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

    The amount of time the patient spends on the dental chair at each visit measured in minutes; and treatment length in months

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

The Efficacy of Lingual Aligners in Adults: a Pilot Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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