Condition category
Oral Health
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
05/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rosy Armstrong

ORCID ID

Contact details

College of Health and Social Care
AD101 Allerton Building
University of Salford
Salford
M6 6PU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8483

Study information

Scientific title

A comparison of community based preventive services to improve child dental health: a single centre randomised interventional prevention trial

Acronym

Study hypothesis

The primary hypotheses are that:
1. There is no difference in the proportions of children with dental caries at age 3 years between test group 1 (behavioural intervention) and the control group
2. There is no difference in the proportions of children with dental caries at 3 years between test group 2 (fluoride varnishing) and the control group

The test interventions will be four semi-annual applications of a fluoride varnish from approximately age 12 months to 30 months, or a ten session group-based behavioural intervention targeting two dental health-related behaviours: establishing twice daily tooth-brushing and a sugar-free bedtime routine, compared to a new standard dental service offered to families with babies aged 9 - 12 months.

There will be no specific criteria for excluding any child in the trial except with reference to the provision of fluoride varnish which is contra indicated with previous hospitalisation because of hypersensitivity reactions including asthma.

Ethics approval

North West 8 REC Greater Manchester East, 26/03/2010, ref: 10/H1013/8

Study design

Single centre randomised interventional prevention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

1. A group-based behavioural intervention targeting two dental health related behaviours: Establishing twice daily tooth-brushing and a sugar-free bedtime routine, The behavioural interventions will be delivered as group sessions of 8 - 10 parents facilitated by a healthcare professional and an 'expert parent'. The intervention will be delivered in blocks of two or three weekly sessions over 10 to 12 sessions as the child's age increases from 12 to 30 months.
2. A clinical intervention of semi annual applications of fluoride varnish (up to 0.4 ml of 0.9% difluorosilane in a polyurethane varnish base). Four doses of topically applied fluoride varnish will be delivered to the deciduous teeth of infants commencing at a minimum age of 12 months and repeated at approximately 18, 24 and 30 months.

Duration of both interventions: 18 months
Follow up length: 24 months
Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Improvement in dental health, measured by the standard dental index (d1mft) number of decayed, extracted and filled teeth. Measured at age 2 years and age 3 years (12 and 24 months from enrolment respectively).

Secondary outcome measures

Enhancement of parental efficacy to undertake two key dental health-related behaviours, measured twice daily at baseline, age 2 and age 3 (enrolment,12 and 24 months).

Overall trial start date

30/04/2010

Overall trial end date

30/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Parents or principal carers of a child between eight and twelve months of age at recruitment
2. Residing in the City of Salford
3. Able to read and understand the study literature with/out a translator/interpreter and provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 732; UK sample size: 732

Participant exclusion criteria

There will be no specific criteria for excluding any child in the trial except with reference to the provision of fluoride varnish which is contra-indicated with previous hospitalisation because of hypersensitivity reactions including asthma.

Recruitment start date

30/04/2010

Recruitment end date

30/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

College of Health and Social Care
Salford
M6 6PU
United Kingdom

Sponsor information

Organisation

University of Salford (UK)

Sponsor details

c/o Tony Warne
Professor in Mental Health Care
Associate Dean (Research)
Head of School
School of Nursing & Midwifery
Mary Seacole Building
Salford
M6 6PU
United Kingdom
+44 (0) 161 295 2779
a.r.warne@salford.ac.uk

Sponsor type

University/education

Website

http://www.salford.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/02/2016: No publications found, study status unverified