The aim of this clinical study is to evaluate the efficacy of an experimental mouthwash used with a marketed whitening toothpaste or a marketed regular fluoride toothpaste, compared to a marketed regular fluoride toothpaste alone, in preventing extrinsic dental stain build-up.
Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
Participant is willing and able to comply with scheduled visits, treatment/application/dosing plan, study restrictions, lifestyle considerations and other study procedures.
A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the ability to understand and follow study procedures and requirements.
Participant with good oral health.
Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
A participant with, in the opinion of the investigator (or medically qualified designee), an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study.
Parallel
Whitening Toothpaste
DrugA toothpaste containing 5% KNO3 and 0.25% NaF.
Experimental Mouthwash
DeviceA mouthwash containing Dipotassium Oxalate.
Regular Fluoride Toothpaste
DrugA marketed regular fluoride toothpaste containing 0.25% NaF.
Mean Total Modified Lobene Stain Index (MLSI) score [Group 1 Versus (vs.) Group 3]
Extrinsic dental stain will be assessed using the MLSI on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth. Area (A) and intensity (I) of extrinsic dental stain will be scored separately at the four gingival and body sites on the scale 0 to 3, where 0 equal to (=) Area with no stain and no intensity, 1= Area with stain covering up to one third of region and light stain intensity, 2= Area with stain covering up to two thirds of region and moderate stain intensity, 3= Area with stain covering more than two thirds of region and heavy stain intensity. The MLSI score for sites will be calculated by multiplying the Area score by the Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition. Mean Total MLSI Score is mean of MLSI score across all evaluable tooth surfaces.
Mean Total MLSI score (Group 1 vs. Group 3)
Extrinsic dental stain will be assessed using the MLSI on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain will be scored separately at the four gingival and body sites on the scale 0 to 3, where 0= Area with no stain and no intensity, 1= Area with stain covering up to one third of region and light stain intensity, 2= Area with stain covering up to two thirds of region and moderate stain intensity, 3= Area with stain covering more than two thirds of region and heavy stain intensity. The MLSI score for sites will be calculated by multiplying the Area score by the Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition. Mean Total MLSI Score is mean of MLSI score across all evaluable tooth surfaces.
Mean Total MLSI score (Group 2 vs. Group 3)
Extrinsic dental stain will be assessed using the MLSI on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain will be scored separately at the four gingival and body sites on the scale 0 to 3, where 0= Area with no stain and no intensity, 1= Area with stain covering up to one third of region and light stain intensity, 2= Area with stain covering up to two thirds of region and moderate stain intensity, 3= Area with stain covering more than two thirds of region and heavy stain intensity. The MLSI score for sites will be calculated by multiplying the Area score by the Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition. Mean Total MLSI Score is mean of MLSI score across all evaluable tooth surfaces.
Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 1 vs. Group 3)
Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth using MLSI. The facial surface of each assessable tooth will be divided into gingival site, body site and interproximal site. Area and Intensity of extrinsic dental stain will be scored separately for each teeth on the scale 0 to 3 and the mean score will be presented, where 0= No stain and no intensity, 1= Stain covering up to one third of region and light stain intensity, 2= Stain covering up to two thirds of region and moderate stain intensity, 3= Stain covering more than two thirds of region and heavy stain intensity. MLSI score= Area score multiplied by Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition.
Mean MLSI score for: Gingival Sites, Body Sites and Interproximal Sites (Group 2 vs. Group 3)
Extrinsic dental stain will be assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth, and lingual surfaces of the 6 mandibular anterior teeth using MLSI. The facial surface of each assessable tooth will be divided into gingival site, body site and interproximal site. Area and Intensity of extrinsic dental stain will be scored separately for each teeth on the scale 0 to 3 and the mean score will be presented, where 0= No stain and no intensity, 1= Stain covering up to one third of region and light stain intensity, 2= Stain covering up to two thirds of region and moderate stain intensity, 3= Stain covering more than two thirds of region and heavy stain intensity. MLSI score= Area score multiplied by Intensity score. Thus, the minimum and maximum possible total scores will be 0 and 9 respectively. Lower score indicates an improvement in condition.
