The Efficacy of Lingual Aligners in Adults. | NCT06050655

Studies
The Efficacy of Lingual Aligners in Adults.

NCT06050655

Sponsor

University Hospital, Geneva

Status

Enrolling by invitation

Last Update Posted

Oct 18, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Malocclusion, Angle Class I

Interventions

Lingual aligners

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 19, 2024Actual

Primary Completion Date

Feb 2025Estimated

Completion Date

Aug 2025Estimated

First Submitted Date

Sep 8, 2023

First Submission Date that Met QC Criteria

Sep 18, 2023

First Posted Date

Sep 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2024

Last Update Posted Date

Oct 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adults with Angle Class I malocclusion	Experimental	Adults older than 18 years old About to undergo orthodontic treatment	Device: Lingual aligners

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lingual aligners	Device	orthodontic treatment with lingual aligners	Adults with Angle Class I malocclusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Patient discomfort / pain	Rate of Patient discomfort using the visual assessment scale	Each patient visit, through study completion, an average of 10 months
Appliance defects	Rate of Breakage or cracking of the aligners

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Geneva		Geneva	Canton of Geneva	1205	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008311	Malocclusion, Angle Class I

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided