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

Sponsor

Royal Surrey County Hospital NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT04588831

Collaborator

King's College London (Other)

Enrollment

Arms

38.5

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mouth Protectors	Device: Mouthguard	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 16, 2016

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-fabricated	Device: Mouthguard Protective device for orofacial complex for patients playing contact sports
Experimental: Mouth-formed	Device: Mouthguard Protective device for orofacial complex for patients playing contact sports
Experimental: Custom-fitted	Device: Mouthguard Protective device for orofacial complex for patients playing contact sports

Arm

Intervention/Treatment

Experimental: Pre-fabricated

Device: Mouthguard

Protective device for orofacial complex for patients playing contact sports

Experimental: Mouth-formed

Device: Mouthguard

Protective device for orofacial complex for patients playing contact sports

Experimental: Custom-fitted

Device: Mouthguard

Protective device for orofacial complex for patients playing contact sports

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Royal Surrey County Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT04588831

Other Study ID Numbers:

RoyalSurreyNHS

First Posted:

Oct 19, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Royal Surrey County Hospital NHS Foundation Trust

mouth protectors

Study Results

No Results Posted as of Oct 19, 2020