NCT02623283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

3.4 years

First QC Date

November 19, 2015

Last Update Submit

April 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Participants will have a full dental examination but no operative intervention

Eligibility Criteria

Age24 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • A participant on the original Tayside Brushing Study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Broxden Dental Centre

Perth, Scotland, PH1 1JT, United Kingdom

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Dental Director

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 7, 2015

Study Start

December 1, 2015

Primary Completion

April 19, 2019

Study Completion

April 19, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations