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

Royal Surrey County Hospital NHS Foundation Trust30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Mouth Protectors

Interventions

Eligibility

Sex: ALLMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 4 years