CompletedNCT04588831Updated Oct 19, 2020

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

An interventional study of Mouthguard in Mouth Protectors, sponsored by Royal Surrey County Hospital NHS Foundation Trust. Completed. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Royal Surrey County Hospital NHS Foundation Trust · Not applicable, Interventional, and Prevention

From the registry’s dates

Registered 3 years 11 months after the study started (first participant enrolled Oct 2016, registered Oct 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 10 Years and older
Sex: All

Study 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 studied

Mouth Protectors

Keywords

mouth protectors

In context

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 10 Years and older
Sexes eligible: 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

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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
Pre-fabricated
Device: Mouthguard
Experimental
Mouth-formed
Device: Mouthguard
Experimental
Custom-fitted
Device: Mouthguard

Interventions

DeviceMouthguard
Protective device for orofacial complex for patients playing contact sports

What researchers measure

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

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 34748017 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04588831
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Collaborators: King's College London
Responsible party: Sponsor
First posted: Oct 19, 2020
Start date: Oct 16, 2016
Primary completion: Jan 2020
Completion: Jan 2020
Last update: Oct 19, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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