NCT02151058.

Methods	Title: a clinical trial to test the effect of a marketed mouthrinse on stain removal Trial design: single‐blinded, randomised controlled trial Location: not reported Language: English Number of centres: 1 Recruitment period: not reported Funding source: Johnson & Johnson Consumer and Personal Products Worldwide
Participants	Participants: 18 to 65 years Total number: 225 Inclusion criteria: able to comprehend and follow the requirements of the study (including availability on scheduled visits) able to provide written informed consent male or non‐pregnant non‐lactating medically acceptable forms of birth control that may be used by the subject and/or his/her partner able to read and understand the local language able to follow study procedures; willing for this to be the only investigational product used during this time period; and willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the investigator Exclusion criteria: suspected alcohol or substance abuse females who are pregnant or breastfeeding known sensitivity or history of significant adverse effects to any of the investigational products significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study participated in tooth stain removal trials in the last 3 months participation in any other clinical study within 30 days of visit 1 subjects who are related to those persons involved directly or indirectly with the conduct of this study Number randomised: not reported Method of randomisation: not reported Method of allocation concealment: not reported Method of blinding: not reported Number evaluated: not reported
Interventions	Total number of intervention groups: 3 Negative control: Colgate® Regular Cavity Protection Experimental: experimental mouthrinse Active comparator: Crest® 3D White MultiCareWhitening Rinse
Outcomes	Reduction in stain
Notes	Sample size calculation: not reported A protocol for a randomised controlled trial. Full text not available Contact: not reported