The Efficacy of Lingual Aligners in Adults.

NCT06050655 | Enrolling By Invitation

• 1 other identifier: 2023-D0045
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Malocclusion, Angle Class I

Outcome Measures

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

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

Secondary Outcomes (4)

• Patient discomfort / pain

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

• Appliance defects

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

• Patient compliance

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

• Chair and treatment time

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

Study Arms (1)

Adults with Angle Class I malocclusion

EXPERIMENTAL

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

Device: Lingual aligners

Interventions

Lingual aligners DEVICE

orthodontic treatment with lingual aligners

Adults with Angle Class I malocclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 22, 2023
• Study Start: September 19, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)