Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy

Study Overview
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Brief Summary
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There is no current evidence on the comfort or wearability of orthodontic mouthguards. These mouthguards adapt to the mouth without the need for dental impressions and laboratory facilities and are suggested to be more comfortable for orthodontic patients by allowing the teeth to move during treatment without the need for them to be replaced regularly during treatment. This study aims to assess and compare the comfort and wearability of orthodontic mouthguards with custom-fitted mouthguards. The results of this study will allow orthodontists to provide evidence-based information to individuals undergoing fixed appliance therapy.

Official Title
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Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy: a Single-center, Single Blind Randomized Cross-over Trial

Conditions
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Mouth Protectors

Intervention / Treatment
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* Device: Mouthguard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing active orthodontic treatment with pre-adjusted edgewise fixed appliances only for a minimum period of 9 months Playing sports where the use of a mouthguard is recommended Playing at least 120 minutes of sport (match or training) during a 6-8 week period Class I, II or mild III (edge-to-edge) incisor malocclusion Able to complete a VAS questionnaire No diagnosed sensory processing disorder Exclusion Criteria: Undergoing active orthodontic treatment that is not pre-adjusted edgewise fixed appliances, or requires a fixed expander, or treatment is likely to be completed within 9 months Playing sports where the use of a mouthguard is not recommended Playing less than 120 minutes of sport (match or training) during a 6-8 week period Moderate to severe class III (reverse overjet) incisor malocclusion Unable to complete a VAS questionnaire Have a diagnosed sensory processing disorder

Ages Eligible for Study
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Minimum Age: 10 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-fabricated<br> | Device: Mouthguard<br>* Protective device for orofacial complex for patients playing contact sports<br>|
| Experimental: Mouth-formed<br> | Device: Mouthguard<br>* Protective device for orofacial complex for patients playing contact sports<br>|
| Experimental: Custom-fitted<br> | Device: Mouthguard<br>* Protective device for orofacial complex for patients playing contact sports<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort and wearability of all three mouthguards | The primary and only outcome of this study was the response to each question of the administered questionnaire. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mouth protectors