The Efficacy of Lingual Aligners in Adults.

Malocclusion, Angle Class I Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06050655
• Other study ID #: 2023-D0045
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Geneva
• Contact: GREGORY ANTONARAKIS, DMD
• Phone: +41 22 3794020
• Email: GREGORY.ANTONARAKIS[@]UNIGE.CH
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class I

Intervention

Device:
• Lingual aligners
orthodontic treatment with lingual aligners

Locations

Country	Name	City	State
Switzerland	University of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient discomfort / pain	Rate of Patient discomfort using the visual assessment scale	Each patient visit, through study completion, an average of 10 months
Secondary	Appliance defects	Rate of Breakage or cracking of the aligners	Each patient visit, through study completion, an average of 10 months
Secondary	Patient compliance	Indice of Patient compliance evaluated with a questionnaire	Each patient visit, through study completion, an average of 10 months
Secondary	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	Each patient visit, through study completion, an average of 10 months .