Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
16/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr C Tredwin

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263177895

Study information

Scientific title

Investigation of the cellular effects and clinical effectiveness of currently prescribed doses of carbamide peroxide tooth whitening products: a randomised controlled trial

Acronym

Study hypothesis

What is the effect of differing concentrations of carbamide peroxide tooth whitening products on the oral hard and soft tissues?

Ethics approval

University College Hospitals NHS Foundation Trust Ethics Committee, July 2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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 names

Carbamide peroxide

Primary outcome measures

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 trial start date

09/03/2006

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers (aged 19- 53 years, either sex)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

09/03/2006

Recruitment end date

01/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Eastman Dental Hospital
London
WC1X 8LD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

University College London Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes