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

Mouth Protectors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588831
• Other study ID #: RoyalSurreyNHS
• Status: Completed
• Phase: N/A
• Start date: October 16, 2016
• Est. completion date: January 2020

Study information

• Verified date: October 2020
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mouth Protectors

Intervention

Device:
• Mouthguard
Protective device for orofacial complex for patients playing contact sports

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust	King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years