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The Efficacy of Lingual Aligners in Adults.

Primary Purpose

Malocclusion, Angle Class I

Status

Not yet recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Lingual aligners

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Geneva

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adults with Angle Class I malocclusion

Arm Description

Adults older than 18 years old About to undergo orthodontic treatment

Outcomes

Primary Outcome Measures

Tooth movement

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

Secondary Outcome Measures

Patient discomfort / pain

Rate of Patient discomfort using the visual assessment scale

Appliance defects

Rate of Breakage or cracking of the aligners

Patient compliance

Indice of Patient compliance evaluated with a questionnaire

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

Full Information

NCT ID

NCT06050655

First Posted

September 8, 2023

Last Updated

September 18, 2023

Sponsor

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT06050655

Brief Title

The Efficacy of Lingual Aligners in Adults.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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?

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion, Angle Class I

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adults with Angle Class I malocclusion

Arm Type

Experimental

Arm Description

Adults older than 18 years old About to undergo orthodontic treatment

Intervention Type

Device

Intervention Name(s)

Lingual aligners

Intervention Description

orthodontic treatment with lingual aligners

Primary Outcome Measure Information:

Title

Tooth movement

Description

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 Outcome Measure Information:

Title

Patient discomfort / pain

Description

Rate of Patient discomfort using the visual assessment scale

Time Frame

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

Title

Appliance defects

Description

Rate of Breakage or cracking of the aligners

Time Frame

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

Title

Patient compliance

Description

Indice of Patient compliance evaluated with a questionnaire

Time Frame

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

Title

Chair and treatment time

Description

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 .

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

GREGORY ANTONARAKIS, DMD

Phone

+41 22 3794020

GREGORY.ANTONARAKIS@UNIGE.CH

First Name & Middle Initial & Last Name or Official Title & Degree

FABIANA MUTZENBERG, DMD

Phone

+41 22 3794020

FABIANA.MUTZENBERG@UNIGE.CH

Facility Information:

Facility Name

University of Geneva

City

Geneva

ZIP/Postal Code

1205

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

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The Efficacy of Lingual Aligners in Adults.

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