An evaluation of a model system for active prevention in the general dental service.
| ISRCTN | ISRCTN88646311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88646311 |
| Protocol serial number | RDO/90/19 |
| Sponsor | Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK) |
| Funder | NHS National Programme for Primary Dental Care (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Anthony Blinkhorn
Scientific
Scientific
Dept of Dental Health and Medicine
Dental School Higher
University of Manchester
Cambridge Street
Manchester
M15 6FH
United Kingdom
| Phone | +44 (0)161 2756610 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | A randomised, controlled trial will evaluate the benefit to child patients aged 2-5 years of a structured, practice-based dental health education package given to parents by dental health educators over a two year period. The null hypotheses tested will be: 1. The secondment of dental health educators to general dental practices will not influence the caries incidence of 'at risk' regularly attending pre-school child patients over a two year period. 2. There will be no cost-effective health gain from the use of dental health educators in the general practice setting. 3. The parents in the test group will not increase their knowledge on the prevention of caries more than those in the control group. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral health/stomatognathic diseases |
| Intervention | 1. Control group children given a toothbrush and toothpaste and the parents will be interviewed and given instruction in the child's oral hygiene; they will be recalled at the end of two years, re-examined and the parents interviewed again. 2. Test group children will be given three dental health education visits at the beginning and one recall visit every 4 months for the two year study period. Children also given toothbrush and toothpaste and parents interviewed. The dental health education package will consist of detailed counselling on sugar control and the use of fluoride toothpaste for young children. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of caries |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 5 Years |
| Sex | All |
| Key inclusion criteria | Children 2-5 years |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/10/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dept of Dental Health and Medicine
Manchester
M15 6FH
United Kingdom
M15 6FH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/10/2003 | Yes | No |