NCT00881790

Brief Summary

The behaviour of 12 dental nurses seeing 600 nursery school children in East Scotland will be video-taped to determine the interaction patterns adopted by the staff in the application of a fluoride varnish to the surfaces of the child's teeth. The aim is to test the benefit of certain communication strategies used by the nurses to affect an efficient application controlling for nursery school site, age of child and experience of dental nurse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

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

Study Start

First participant enrolled

April 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

April 14, 2009

Last Update Submit

January 9, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Distinct defined communicative behaviour of dental nurse

    6 months

Study Arms (1)

Fluoride application

Other: Fluoride varnish

Interventions

the topical application of fluoride varnish to all surfaces of exposed teeth

Also known as: Duraphat
Fluoride application

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Nursery school children from designated nursery schools (from under resourced communities) in East Scotland. Health Boards involved include: Fife, Forth Valley and Tayside

You may qualify if:

  • children attending nursery schools (to be designated in the Health Boards described above)

You may not qualify if:

  • consent of parent not supplied
  • learning difficulties
  • child refuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of St Andrews

St Andrews, Fife, KY16 9TS, United Kingdom

Location

Related Publications (1)

  • Zhou Y, Humphris GM. Reassurance and distress behavior in preschool children undergoing dental preventive care procedures in a community setting: a multilevel observational study. Ann Behav Med. 2014 Aug;48(1):100-11. doi: 10.1007/s12160-013-9566-7.

Related Links

MeSH Terms

Conditions

Dental Caries

Interventions

sodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Gerald M Humphris, PhD

    Univ of St Andrews

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of Health Psychology

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2011

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations