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Completed

NCT Number: NCT04588831

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

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.

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Key information

Conditions

Mouth Protectors

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mouthguard

Device

Protective device for orofacial complex for patients playing contact sports

Primary outcomes

  1. Comfort and wearability of all three mouthguards

    Time frame: 4 years

    The primary and only outcome of this study was the response to each question of the administered questionnaire.

Sponsors and collaborators

Lead sponsor

Royal Surrey County Hospital NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2020
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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