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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN32619484
Enrollment
30
Registered
2006-09-29
Start date
2006-03-09
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth whitening Oral Health Tooth whitening

Interventions

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 w

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026