A study of the demineralising potential of cooked Chinese starches with an in situ caries model
| ISRCTN | ISRCTN91273252 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91273252 |
| Protocol serial number | N0436118019 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 28/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss L Matthaiou
Scientific
Scientific
Department of Child Dental Health
Leeds Dental Institute
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom
| Phone | +44 (0)113 233 6177 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To measure the effect on enamel microhardness of three test foods as compared to a 10% sucrose solution and a 10% sorbitol solution. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Cariology |
| Intervention | Randomised controlled trial. Random allocation to: 1. Test food one 2. Test food two 3. Test food three 4. 10% sucrose solution 5. 10% sorbitol solution |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 10% sucrose solution, 10% sorbitol solution |
| Primary outcome measure(s) |
Demineralisation of enamel slabs (assessed by changes in microhardness) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 8 |
| Key inclusion criteria | Eight fit and healthy adults recruited from staff of the Leeds Dental Institute, Leeds NHS Trust, Leeds University, students (other than undergraduate dental students) of Leeds University. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 24/03/2003 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Child Dental Health
Leeds
LS2 9LU
United Kingdom
LS2 9LU
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 |
