Cellular effects and clinical effectiveness of currently prescribed doses of carbamide peroxide tooth whitening products

ISRCTN	ISRCTN32619484
DOI	https://doi.org/10.1186/ISRCTN32619484
Protocol serial number	N0263177895
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	University College London Hospitals NHS Foundation Trust (UK), NHS R&D Support Funding (UK)

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

Department of Conservation
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Carbamide peroxide
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2007

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Eastman Dental Hospital

London
WC1X 8LD
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