The Tayside Brushing Study - Adult Follow up

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623283
• Other study ID #: 186595
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: April 19, 2019

Study information

• Verified date: April 2019
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 26 Years

Eligibility

Inclusion Criteria:

• A participant on the original Tayside Brushing Study

Exclusion Criteria:

Related Conditions & MeSH terms

• Dental Caries

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Broxden Dental Centre	Perth	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries experience (The number of each participant's Decayed, Missing and Filled Teeth (DMFT))	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