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

NCT04588831 | Completed

• 1 other identifier: RoyalSurreyNHS
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mouth Protectors

Keywords

mouth protectors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Pre-fabricated

EXPERIMENTAL

Device: Mouthguard

Mouth-formed

EXPERIMENTAL

Device: Mouthguard

Custom-fitted

EXPERIMENTAL

Device: Mouthguard

Interventions

Mouthguard DEVICE

Protective device for orofacial complex for patients playing contact sports

Custom-fitted; Mouth-formed; Pre-fabricated

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead
• King's College London: collaborator

Related Publications (1)

• 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.

  PMID: 34748017 DERIVED

MeSH Terms

Interventions

Mouth Protectors

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: October 16, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10