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

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 Overview

• Status: Completed
• Conditions: Mouth Protectors
• Intervention / Treatment: Device: Mouthguard

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Collaborators: King's College London

Publications and helpful links

General Publications

• Kalra A, Harrington C, Minhas G, Papageorgiou SN, Cobourne MT. Wearability and preference of mouthguard during sport in patients undergoing orthodontic treatment with fixed appliances: a randomized clinical trial. Eur J Orthod. 2022 Jan 25;44(1):101-109. doi: 10.1093/ejo/cjab062.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: mouth protectors
• Other Study ID Numbers: RoyalSurreyNHS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No