The Tayside Brushing Study - Adult Follow up

Sponsor
NHS Tayside (Other)
Overall Status
Completed
CT.gov ID
NCT02623283
Collaborator
(none)
68
1
40.6
1.7

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
68 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
Actual Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Apr 19, 2019
Actual Study Completion Date :
Apr 19, 2019

Outcome Measures

Primary Outcome Measures

  1. Caries experience (The number of each participant's Decayed, Missing and Filled Teeth (DMFT)) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years to 26 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • A participant on the original Tayside Brushing Study
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Broxden Dental Centre Perth Scotland United Kingdom PH1 1JT

Sponsors and Collaborators

  • NHS Tayside

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Morag Curnow, Clinical Dental Director, NHS Tayside
ClinicalTrials.gov Identifier:
NCT02623283
Other Study ID Numbers:
  • 186595
First Posted:
Dec 7, 2015
Last Update Posted:
Apr 22, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2019