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The Tayside Brushing Study - Adult Follow up

19 aprile 2019 aggiornato da: Dr Morag Curnow, NHS Tayside

Assessing the Long-term Effects of a School-to-home Childhood Supervised Brushing Programme in Young Adults From High Caries Risk Groups - The Tayside Brushing Study Adult Follow up

Historically dental health of Scottish children had been poor for many years. Evidence form clinical trials of fluoride toothpaste identified a route to improving prevention. Those who had poor dental health used fluoride toothpaste infrequently at home. The investigators hypothesised that this disadvantage could be overcome by supplying toothpaste to disadvantaged families and supervising child toothbrushing at school. In 1997, 534 children 5.3 years were recruited in 12 primary schools in Tayside; randomly assigned to one of two groups - test group followed a home-to-school toothbrushing programme with fluoride toothpaste; control group: usual care. Children in test group were provided with toothbrushes and toothpaste (1,000ppmF as sodium monofluorophosphate) for home use; also brushed their teeth school daily. After 2 years, children participating in the supervised brushing programme developed significantly less caries (tooth decay).

Permission was given for longitudinal follow up of children and dental records. The original intervention lasted 30 months and children were re-examined at 36 months after baseline, 48, 60 and 84 months. At 84 month examination, 77% were available, found prolonged benefits of brushing programme. This was 4.5 years after the end of the programme; children were aged 11.5 years. At age 14 years, 6.5 years after intervention end, 65% of children were reexamined; benefit was still evident at 20-26% less caries experience. However, there had been greater subject loss and insufficient funds available to undertake a more individual followup of participants.

Since then, records have been followed; up-to-date contact details identified. Using this new data, the investigators seek to reconsent the participants, now aged 23 to invite them to attend a followup dental examination. This study has the potential to provide unique information on longterm costs and benefits of a home-to-school toothbrushing programme.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Participants on the original trial will be sent an information letter and information leaflet and consent form in the post. The letter will provide contact details for the chief investigator (CI) should they wish to discuss the study before making a decision about whether they would like to take part. The letter will ask participants to complete the informed consent form and return it to the Chief Investigator in the pre-paid envelope provided. If participants do not respond to the first letter a second will be sent two weeks later. No further letters will be sent.

The consent form will ask participants to give details of which days and times are most convenient for them to attend an appointment (evening and weekend appointments will be offered). The letter will advise people that attendance does not replace their usual dental care visits. For those who do not have a dentist and wish to find one, appropriate advice and assistance will be provided by the CI, or a member of the Dental Team.

Participants who return their consent forms will be contacted by telephone by a member of the NHS Tayside dental team to arrange an appointment at a time convenient to them. If participants are unable to travel to the two centres (Broxden Dental Centre in Perth or Kings Cross Dental Department in Dundee) they may be offered a home visit.

When participants attend for their appointment they will be asked to confirm their consent verbally. Dr Morag Curnow (the same dentist that examined the participants when they were in School on the original toothbrushing trial) or another appropriately trained Dentist (named on the study delegation log) will conduct a short dental examination, recording the presence of plaque on anterior teeth and the caries status of each tooth surface using dental lighting and fibre-optic transillumination. The examining dentist will be unaware of which study group the adults belonged to when they were child participants in the trial. Participants will also be asked to complete oral health related questionnaires. Questionnaires will be analysed by a statistician.

Participants will be asked to give consent for their dental records to be accessed using health service records to record dental treatment history. Consent will be recorded in writing. Approval has already been provided by Information Services Division (ISD), NHS National Services Scotland to access the dental treatment records.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

68

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Scotland
      • Perth, Scotland, Regno Unito, PH1 1JT
        • Broxden Dental Centre

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 24 anni a 26 anni (Adulto)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adults aged 25 who were enrolled on the Tayside Brushing Study Randomised Controlled Trial

Descrizione

Inclusion Criteria:

  • A participant on the original Tayside Brushing Study

Exclusion Criteria:

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caries experience (The number of each participant's Decayed, Missing and Filled Teeth (DMFT))
Lasso di tempo: Over an eight week period, each participant will be examined once
The number of each participant's Decayed, Missing and Filled Teeth (DMFT), recorded by and extrapolated from surfaces (DMFS)
Over an eight week period, each participant will be examined once

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 dicembre 2015

Completamento primario (Effettivo)

19 aprile 2019

Completamento dello studio (Effettivo)

19 aprile 2019

Date di iscrizione allo studio

Primo inviato

19 novembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

4 dicembre 2015

Primo Inserito (Stima)

7 dicembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 186595

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Carie dentale

Prove cliniche su No intervention given

3
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