Tooth whitening clinical trial
Research type
Research Study
Full title
The clinical effectiveness of 5% Carbamide Plus, 10% Carbamide Plus compared to two commercially available 10% Carbamide peroxide products: a double blind randomised placebo controlled clinical trial
IRAS ID
198404
Contact name
Ailbhe McDonald
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2016/06/88, UCL Data Protection Registration number
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
Tooth whitening with whitening gels can offer an alternative treatment for patients desiring whiter teeth, which in comparison has a lower cost and does not involve destruction of the dental hard tissues compared with crowns and veneers.
This study will take place in the Eastman Dental Hospital (University College London Hospitals. It will test 4 different formulations of tooth whitening gels and a placebo gel on adult volunteers (18 years and above) within the Eastman Dental Hospital.
The study will be carried out by Derek Hall (Specialty Registrar in Restorative Dentistry/Postgraduate Student studying for an MSc Conservative Dentistry).
The volunteers will be recruited from the staff members of UCLH and UCL who work in the hospital/university.
The volunteers will be randomised into 5 groups with each group using a different whitening gel or the placebo gel. Each participant will undergo a dental screening to make sure they are suitable for the study. This screening will include a dental examination and impressions of their teeth. Tooth whitening trays will be constructed from the impressions and the participants will attend for fitting of the trays along with instructions on how to use the tooth whitening gel.
The tooth whitening will be carried out by the participants at home for a 2 week period. The patients will be reviewed at 2 weeks, 3 months then 6 months. At each review the colour change in the teeth will be measured along with any increase in tooth sensitivity. The tooth colour will be assessed by a hand held device that measures the colour of the teeth and the tooth sensitivity assessed with a patient questionnaire.
The purpose of the study will be to assess if one preparation is superior over the other preparations with regards to colour change of the teeth (better whitening effect).
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0418
Date of REC Opinion
26 Jul 2016
REC opinion
Favourable Opinion