Evaluate Effect of a Toothpaste on Chlorhexidine Tooth Staining
Research type
Research Study
Full title
A study to evaluate the effect of a 67% Sodium Bicarbonate containing toothpaste on Chlorhexidine Digluconate tooth staining.
IRAS ID
134057
Contact name
Robert Maclure
Contact email
Sponsor organisation
GlaxoSmithKline Consumer Healthcare
Eudract number
2013-002418-11
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Chlorhexidine mouthwash is an antiseptic and disinfectant that is aimed at preventing plaque and prevents and treats gingivitis. Tooth staining is a major side effect of Chlorhexidine even with twice daily tooth brushing. It is thought that Chlorhexidine induced staining first occurs at the contact point between adjacent teeth and is more common in smokers. The use of a toothpaste with low abrasivity and good stain control properties would make the use of Chlorhexidine more acceptable to users concerned about staining.
The aim of this study is to compare the stain control effect of twice daily brushing with a sodium bicarbonate toothpaste versus a toothpaste without sodium bicarbonate during a 6 week course of Corsodyl 0.2% mouthwash.
This study is being run by GlaxoSmithKline Consumer Healthcare and will be conducted at Intertek CRS.
Healthy subjects aged 18 – 64 who currently suffer with tooth stain and moderate gingivitis will be invited to participate in the study.
Subjects will be required to attend the following visits over an 8 week period:
Visit 1 – assessments will be carried out to confirm eligibility. Eligible subjects will be provided with a standard toothpaste and toothbrush for brushing at home until the next visit.
Visit 2 – an oral soft tissue exam will be performed followed by measurement of baseline staining and the front teeth will be cleaned and flossed. Digital images will be taken. Subjects will be allocated to their study treatment regime.
Visit 3 – an oral soft tissue exam will be performed followed by measurement of staining following 3 weeks of product use. Digital images will be taken.
Visit 4 - an oral soft tissue exam will be performed followed by measurement of staining following 6 weeks of product use. Digital images will be taken. Subjects will be offered a scale and polish.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
13/EM/0274
Date of REC Opinion
12 Aug 2013
REC opinion
Further Information Favourable Opinion