NCT04588831

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mouth Protectors

Interventions

Type	Name	Description
DEVICE	Mouthguard	Protective device for orofacial complex for patients playing contact sports

Timeline

• Start date: 2016-10-16
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2020-10-19
• Last updated: 2020-10-19