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

Royal Surrey County Hospital NHS Foundation Trust

Status

Completed

Conditions

Mouth Protectors

Treatments

Device: Mouthguard

Study type

Interventional

Funder types

Other

Identifiers

NCT04588831

RoyalSurreyNHS

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

10+ years old

Volunteers

Accepts Healthy Volunteers

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