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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04588831

Enrollment

Registered

2020-10-19

Start date

2016-10-16

Completion date

2020-01-31

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mouth Protectors

Keywords

mouth protectors

Brief summary

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.

Interventions

DEVICEMouthguard

Protective device for orofacial complex for patients playing contact sports

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026