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The Tayside Brushing Study - Adult Follow up

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ClinicalTrials.gov Identifier: NCT02623283
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : April 13, 2017
Information provided by (Responsible Party):
Dr Morag Curnow, NHS Tayside

Brief Summary:

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.

Condition or disease Intervention/treatment
Dental Caries Other: No intervention given

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 534 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : December 2015
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Intervention Details:
    Other: No intervention given
    Participants will have a full dental examination but no operative intervention

Primary Outcome Measures :
  1. Caries experience (The number of each participant's Decayed, Missing and Filled Teeth (DMFT)) [ Time Frame: 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years to 26 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults aged 25 who were enrolled on the Tayside Brushing Study Randomised Controlled Trial

Inclusion Criteria:

  • A participant on the original Tayside Brushing Study

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623283

Contact: Morag Curnow, BDS 01738450550 ext 1 morag.curnow@nhs.net

United Kingdom
Broxden Dental Centre Recruiting
Perth, Scotland, United Kingdom, PH1 1JT
Contact: Morag Curnow, BDS    01738 450550 ext 1    morag.curnow@nhs.net   
Sponsors and Collaborators
NHS Tayside

Responsible Party: Dr Morag Curnow, Clinical Dental Director, NHS Tayside
ClinicalTrials.gov Identifier: NCT02623283     History of Changes
Other Study ID Numbers: 186595
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases