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Evaluation of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention

21. september 2022 oppdatert av: Queen Mary University of London

Evaluation of the Effect of Tailored Electronic Reminders on Compliance With Removable Orthodontic Retention: A Randomised Controlled Trial

Participants will be recruited for inclusion at a routine adjustment appointment prior to planned removal of the appliances. Following removal of the appliances, consenting participants will be randomly allocated to one of two groups by computer-generated random allocation. Allocation will be concealed from the treating clinician using of an opaque sealed envelope system. Standard stone model records will be available for all participants following removal of the appliances (T0).

Participants in both groups will have follow-up scheduled for 3 (T1), 6 (T2) and 12 (T3) months following removal of the braces. All participants will be instructed to wear standard clear, plastic (Essix-type) retainers on a full-time basis for 6 months, followed by night-time wear for a further 6 months. A micro-electronic timer will be integrated within the upper Essix-type retainer. All participants will be given standard advice at each recall visit.

Participants in the intervention group will receive tailored electronic reminders in the form of a mobile application. The frequency and content of the reminders will be informed by qualitative interviews involving participants from an allied trial, and from posts related to orthodontic retainers shared on social media. Instructions on the necessary duration of retention, maintenance of retainers, departmental details, allied to advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear will be included. Also, information related the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application. Participants in the control group will not receive additional reminders. Treating clinicians will be kept blind to the study group.

All patients failing an appointment will be sent another. Those wishing to withdraw from the trial may do so at any point without affecting continuing care with records taken at the point of withdrawal from the study with data analysis on an intention to treat basis.

Thereafter, patient experiences with electronic reminders will be evaluated on a subset of participants using one-to-one interviews.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Details related to the intervention:

Participants in the intervention group will receive access to the 'My Retainers' mobile application via a unique identification code. The researcher will demonstrate the use of the mobile application with a brief description of its features. Participants in the control group will not have access to the mobile application.

Studietype

Intervensjonell

Registrering (Faktiske)

84

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • London, Storbritannia, E1 1BB
        • The Royal London Hospital Barts Health NHS Trust

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år til 21 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Aged 12 to 21 years
  • Planned for removable retention with Essix-type vacuum-formed retainers
  • In the permanent dentition

Exclusion Criteria:

  • Inability to access or peruse electronic mail
  • Cleft lip and palate and other craniofacial anomalies

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Receive electronic reminder
Participants in the intervention group will receive tailored electronic reminders. The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.
Annen: Electronic reminder
The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.
Ingen inngripen: Control group
Participants in the control group will not receive additional reminders.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wear of removable retainer per day (hours) in the intervention and the control groups
Tidsramme: 3 months - 6 months - 12 months
Objective levels of retainer wear will be recorded from an integrated micro-electronic sensor in the retainer
3 months - 6 months - 12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-reported hours of retainer wear per day
Tidsramme: 3 months - 6 months - 12 months
Subjective levels of retainer wear as reported by participants using retainer wear chart
3 months - 6 months - 12 months
Study model based outcomes
Tidsramme: 3 months - 6 months - 12 months
Stability of teeth following orthodontic treatment measured from study models (in millimetres)
3 months - 6 months - 12 months
Patients' experience with electronic reminders in a related qualitative element (positive and negative experiences, in addition to feedback from participants in relation to tailored electronic reminders based on one-to-one interviews)
Tidsramme: 6 months
Questionnaire
6 months
Assessment of oral hygiene levels and periodontal outcomes including: plaque scores, bleeding on probing, and clinical attachment level
Tidsramme: Baseline - 3 months - 6 months
Clinical assessment
Baseline - 3 months - 6 months
Knowledge with orthodontic retainers
Tidsramme: 3 months
Questionnaire
3 months
Experience with orthodontic retainers
Tidsramme: 3 months - 6 months
Questionnaire
3 months - 6 months
Anxiety levels on the day of debond
Tidsramme: Baseline
Questionnaire
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Queen Mary University of London

Etterforskere

  • Studiestol: Padhraig Fleming, Queen Mary University of London

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. mars 2018

Primær fullføring (Faktiske)

31. desember 2020

Studiet fullført (Faktiske)

31. desember 2020

Datoer for studieregistrering

Først innsendt

24. oktober 2016

Først innsendt som oppfylte QC-kriteriene

19. juli 2017

Først lagt ut (Faktiske)

21. juli 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. september 2022

Sist bekreftet

1. februar 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 11153

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Data will be freely available to reviewers in future and may be made available on a public database

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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