Evidence map›Paper›PMID 34748017›Full record

Trial reportEuropean journal of orthodontics2022

Wearability and preference of mouthguard during sport in patients undergoing orthodontic treatment with fixed appliances: a randomized clinical trial.

Aneesh Kalra, Claire Harrington, Gursharan Minhas, Spyridon N Papageorgiou, Martyn T Cobourne

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of orthodontics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04588831 (Comfort and Wearability of Custom-fitted, Mouth-formed and Pre-fabricated Mouthguards for Patients Undergoing Fixed Appliance Therapy), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04588831 nacompletednot on this map

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

TypeinterventionalSponsorRoyal Surrey County Hospital NHS Foundation TrustRan2016 to 2020Enrolled30ConditionsMouth ProtectorsArmsMouthguard
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 13 citations in OpenAlex.

  1. Evidence Mapping and Quality Assessment of Randomized Controlled Trials in Dental Traumatology.Dental traumatology : official publication of International Association for Dental Traumatology · 2026
    Review
  2. Observational
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Aneesh KalraDepartment of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.
Claire HarringtonDepartment of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.
Gursharan MinhasDepartment of Orthodontics, Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.
Spyridon N PapageorgiouClinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Switzerland.ORCID 0000-0003-1968-3326
Martyn T CobourneCentre for Craniofacial Development & Regeneration, Department of Orthodontics, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, UK.ORCID 0000-0003-2857-0315
King's College London · GBRoyal Surrey County Hospital · GBUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOrthodontic patients wearing fixed appliances are susceptible to traumatic dental injuries during a wide range of sporting activities. This randomized clinical trial investigated wearability and preference of mouthguards during sporting activities in patients undergoing orthodontic treatment with fixed appliances.

methodsA prospective three-arm crossover randomized clinical trial conducted in the UK. Thirty patients in active orthodontic treatment with fixed appliances undertaking at least 120 minutes of contact sport per 6-8-week observation period were randomly assigned to one of six mouthguard allocation sequences consisting of three mouthguard types: (MG1) custom-made laboratory constructed, (MG2) mouth-formed OPRO® Gold Braces, and (MG3) pre-fabricated Shock Doctor® Single Brace. Patients completed a nine-outcome 100-mm visual analogue scale (VAS) questionnaire relating to mouthguard wearability during sport. Once feedback was completed, subjects were allocated the next mouthguard in the sequence. At study-end, subjects were asked to identify their preferred mouthguard.

resultsTwenty-four patients (median age = 13; inter-quartile range 12-14.5 years) completed n = 72 follow-up questionnaires with most playing rugby union or field hockey. Considering VAS score as a continuous variable, for comfort, stability, hardness, ability to breathe, ability to not cause nausea, and inclination to chew, MG2 performed better than MG3. For categorization of VAS score into low (less than 80 mm) or high (at least 80 mm) wearability, for comfort, stability, ability to not cause nausea, and inclination to chew, MG1 and MG2 also rated superior to MG3. Patients preferred MG1 overall.

conclusionsThis randomized clinical trial found that during contact sport patients in fixed appliances reported superior wearability for custom-made and mouth-formed mouthguards in comparison to pre-fabricated. Overall, patients preferred custom-made mouthguards. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov: NCT04588831.

Indexed as

Mouth ProtectorsAdolescentChildEquipment DesignHumansMouthOrthodontic Appliances, FixedProspective Studies

Identifiers

PMID34748017
PMCPMC8789322
OpenAlexW3213545142

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.