The Efficacy of Lingual Aligners in Adults.

October 16, 2024 updated by: Fabiana Mutzenberg, University Hospital, Geneva

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • University of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults with Angle Class I malocclusion
  • Adults older than 18 years old
  • About to undergo orthodontic treatment
Device: Lingual aligners
orthodontic treatment with lingual aligners

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the end of study completion, an average of 10 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Rate of Breakage or cracking of the aligners
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
Indice of Patient compliance evaluated with a questionnaire
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 .
The amount of time the patient spends on the dental chair at each visit measured in minutes; and treatment length in months
Each patient visit, through study completion, an average of 10 months .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-D0045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Primary participant data will only be shared with other researchers upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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