Effectiveness of supervised toothbrushing on prevention of childish dental caries
| ISRCTN | ISRCTN18548869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18548869 |
| Protocol serial number | 06/51300-0 |
| Sponsor | Catholic University of Santos (Universidade Catolica de Santos) (Brazil) |
| Funder | State of Sao Paulo Research Foundation (Fundacao de Amparo a Pesquisa do Estado de Sao Paulo [FAPESP]) (Brazil) |
- Submission date
- 03/11/2007
- Registration date
- 11/12/2007
- Last edited
- 30/03/2011
- 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
Dr Paulo Frazao
Scientific
Scientific
Rua Carvalho de Mendonca 144 - 4th floor
Santos
11070906
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | An interventional community-randomised controlled single-centre trial will be conducted in six preschools with 5 - 6 year-old children. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Cost-effectiveness of supervised toothbrushing on prevention of dental caries in permanent molar first |
| Study objectives | To compare two techniques of direct supervised toothbrushing with fluoridated dentifrice on occurrence of caries lesions in permanent molar first. |
| Ethics approval(s) | Ethics approval received from the Research Ethical Committee from Catholic University of Santos on the 20th November 2005. |
| Health condition(s) or problem(s) studied | Caries lesion on surface of permanent molar first |
| Intervention | Intervention group: A modified technique of direct supervised toothbrushing with fluoridated dentifrice will be carried out in eligible children every 45 days in three randomly selected preschools (test-units). The modified technique includes professional toothbrushing on occlusal surfaces of permanent molar first carried out by trained auxiliary personnel. Control group: A conventional technique of direct supervised toothbrushing with same fluoridated dentifrice will be carried out in eligible children every 90 days in three preschools (control-units). Total duration of intervention and follow-up is the same: twenty-four months |
| Intervention type | Other |
| Primary outcome measure(s) |
Enamel caries measured by visual exam with aid of a ball point instrument recommended by World Health Organization. The outcomes will be measured at first, 6th, 12th and 18th month. |
| Key secondary outcome measure(s) |
Dentine caries measured by visual exam with aid of a ball-point instrument recommended by World Health Organization. The outcomes will be measured at first, 6th, 12th and 18th month. |
| Completion date | 02/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | Eligible subjects with one or more sound erupted permanent molar first. |
| Key exclusion criteria | Infants with condition or disease that increase caries risk. |
| Date of first enrolment | 02/04/2007 |
| Date of final enrolment | 02/05/2009 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rua Carvalho de Mendonca 144 - 4th floor
Santos
11070906
Brazil
11070906
Brazil
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 | 22/03/2011 | Yes | No |
