Condition category
Oral Health
Date applied
16/11/2005
Date assigned
16/11/2005
Last edited
10/12/2007
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

Dr Paul John Allison

ORCID ID

Contact details

Faculty of Dentistry
McGill University
Rm 238D
Strathcona Building
3640
University St.
Montreal
H3A 2B2
Canada
+1 514 398 7203 (00045)
paul.allison@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-63155

Study information

Scientific title

Acronym

Study hypothesis

The hypotheses are that at study completion:
1. Children of caregivers randomised to the intervention group will have a mean number of decayed, missing or filled tooth surfaces (dmfs) one less than that of children whose caregivers were randomised to the control group
2. The proportion of children of caregivers in the intervention group who are caries free will be 20% more than the proportion of children caries free in the control group

Ethics approval

Ethics approval received from the McGill Faculty of Medicine Institutional Review Board on the 6th January 2003.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Early childhood caries

Intervention

The test intervention is an educational one delivered by dental hygienists to parents of infants when the latter are 6, 12, 18 and 24 months old. Each of the four sessions lasts approximately 15 minutes.

The control group receive no intervention i.e. 'normal care'.

Trial details received: 12 September 2005

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of decayed missing and filled tooth surfaces 24 months following recruitment.

Secondary outcome measures

1. Percentage of children without dental caries
2. Parent caries-related knowledge
3. Parent caries-related behaviour
4. Oral health-related impacts/quality of life
5. Child weight
6. Financial costs

Overall trial start date

01/09/2003

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Caregivers (parents) who have a child of five to seven months, either sex (inclusive), with whom they are attending the vaccination clinics of the study community health centre recruitment sites (CLSCs) and who live with that child for 50% or more of the time will be asked to participate
2. The subjects included are parent/infant dyads

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

821

Participant exclusion criteria

Dyads will be excluded if parents are unable to understand the consent form and self-complete questionnaires for linguistic reasons

Recruitment start date

01/09/2003

Recruitment end date

31/05/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Faculty of Dentistry
Montreal
H3A 2B2
Canada

Sponsor information

Organisation

McGill University (Canada)

Sponsor details

3640 University St.
Montreal
H3A 2B2
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63155)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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