Cellular effects and clinical effectiveness of currently prescribed doses of carbamide peroxide tooth whitening products
| ISRCTN | ISRCTN32619484 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32619484 |
| Secondary identifying numbers | N0263177895 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 16/12/2014
- 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
Mr C Tredwin
Scientific
Scientific
Department of Conservation
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | Investigation of the cellular effects and clinical effectiveness of currently prescribed doses of carbamide peroxide tooth whitening products: a randomised controlled trial |
| Study objectives | What is the effect of differing concentrations of carbamide peroxide tooth whitening products on the oral hard and soft tissues? |
| Ethics approval(s) | University College Hospitals NHS Foundation Trust Ethics Committee, July 2006 |
| Health condition(s) or problem(s) studied | Tooth whitening |
| Intervention | 1. Treatment with whitening kits with 10% carbamide peroxide 2. Treatment with whitening kits with 16% carbamide peroxide 3. Treatment with whitening kits with 22% carbamide peroxide 4. Treatment with inactive gel 5. Treatment with 16% whitening strips carbamide peroxide Total duration of active tooth whitening treatment was 14 days. Patient were seen for clinical assessement on Day 0 (start), Day 14 and at 3 months for final review. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Carbamide peroxide |
| Primary outcome measure | Current information as of 26/01/2009: Alteration in tooth colour from the three prescribed agents (non-active placebo, 10% carbamide peroxide and 16% carbamide peroxide) during a 2 week course of tooth whitening and the overall colour stability at 3 months. Initial information at time of registration: 1. To measure the efficacy of carbamide peroxide concentration on rate and longevity of tooth shade variation 2. To investigate the effect of currently used dosages of carbamide peroxide on human oral epithelium |
| Secondary outcome measures | Added 26/01/2009: 1. Soft tissue changes during the active treatment period and on subsequent review 2. Tooth senstivitiy over the active treatment period 3. Patients perceptions of tooth colour at baseline, 2 weeks and 3 months |
| Overall study start date | 09/03/2006 |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Healthy volunteers (aged 19- 53 years, either sex) |
| Key exclusion criteria | 1. Pregnant or breast-feeding women 2. Absence of systemic diseases, periodontal problems or any kind of medication or prosthesis in the regions assigned for the brush biopsy |
| Date of first enrolment | 09/03/2006 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Eastman Dental Hospital
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
University College London Hospitals NHS Foundation Trust (UK)
No information available
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
