The Efficacy of Lingual Aligners in Adults.

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Malocclusion, Angle Class I

Intervention / Treatment
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* Device: Lingual aligners


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Each patient visit, through study completion, an average of 10 months | 
| Patient compliance | Indice of Patient compliance evaluated with a questionnaire | Each patient visit, through study completion, an average of 10 months | 
| 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 . |