Comparison of Oral Health Related Quality of Life Changes Between Clear Aligners and Vestibular Fixed Appliances

Study Overview
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Brief Summary
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Patients who have severe crowding that required four premolars extraction will be treated in this study. The effects of clear aligners therapy on oral health related quality of life (OHRQoL) in comparison with vestibular fixed appliances using the validated OHIP-14 tool during orthodontic treatment. So the aim of the study was to compare the changes in OHRQoL between patients receiving clear aligners or fixed appliances during the first year of the orthodontic treatment. There are two groups: First group (Experimental): the patients in this group will be treated using clear aligners. Second group (Control): the patients in this group will be treated using fixed appliances.

Detailed Description
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For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the CAD/CAM technology, clear aligners treat a broader range of cases with greater precision. They consists of a series of plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

Official Title
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The Effectiveness of Clear Aligners vs Fixed Appliances on Oral Health-related Quality of Life in Patients With Severe Crowding: A 12-months Randomized Controlled Clinical Trial

Conditions
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Teeth Crowding

Intervention / Treatment
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* Device: Vestibular fixed appliances
* Device: Clear aligners


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I malocclusion with severe crowding (more than 5 mm of tooth-size-arch-length-discrepancy). Good oral hygiene and periodontal health. No congenitally missing or extracted teeth (except for the third molars). No history of previous trauma to the maxillofacial region or surgical interventions. Exclusion Criteria: Previous orthodontic treatment. Subject with psychological abnormalities. Subject with systemic diseases. Subject has known allergy to latex and plastic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vestibular fixed appliances<br>Adult patients in this group will be treated using fixed appliances. | Device: Vestibular fixed appliances<br>* The fixed appliances will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.<br>|
| Experimental: Clear aligners<br>Adult patients in this group will be treated using clear aligners. | Device: Clear aligners<br>* The clear aligners will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in oral health related quality of life | Patients in both groups will be given a questionnaire to be filled. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled in 3 minutes. OHIP-14 includes a subjective evaluation of the individual's oral health, functional well-being, emotional well-being, expectations and satisfaction with care and sense of self. | T0: immediately before the start of orthodontic treatment, T1: after 1 week, T2: after 2 weeks, T3: after 1 month, T4: after 6 months, T5: after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clear aligners, Oral health related quality of life, Orthodontic, Vestibular fixed appliances, Oral health impact profile