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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-16

Study Completion Date

2020-01-31

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.

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Detailed Description

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Conditions

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Mouth Protectors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pre-fabricated

Group Type EXPERIMENTAL

Mouthguard

Intervention Type DEVICE

Protective device for orofacial complex for patients playing contact sports

Mouth-formed

Group Type EXPERIMENTAL

Mouthguard

Intervention Type DEVICE

Protective device for orofacial complex for patients playing contact sports

Custom-fitted

Group Type EXPERIMENTAL

Mouthguard

Intervention Type DEVICE

Protective device for orofacial complex for patients playing contact sports

Interventions

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Mouthguard

Protective device for orofacial complex for patients playing contact sports

Intervention Type DEVICE

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

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes