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.
This will be a single-center, 12-week, randomized, controlled, examiner-blind, 3 treatment-arm, parallel-group, stratified clinical study in healthy participants to evaluate impact on the build-up of dental stain after 12 weeks twice daily use of an experimental mouthwash with either a marketed whitening toothpaste containing 5 percent (%) potassium nitrate (KNO3) and 0.25% sodium fluoride (NaF) or with a marketed regular fluoride toothpaste containing 0.25% NaF compared with use of a marketed regular fluoride toothpaste containing 0.25% NaF. Sufficient participants will be screened to ensure approximately 360 participants are randomized to treatment groups and approximately 342 participants complete the study (approximately 114 participants per treatment group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
360
A toothpaste containing 5% KNO3 and 0.25% NaF.
A mouthwash containing Dipotassium Oxalate.
A marketed regular fluoride toothpaste containing 0.25% NaF.
All Sum Research Center LTD
Melbourne, Florida, United States
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.
Time frame: At Week 12
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.
Time frame: At Week 6
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.
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Time frame: At Week 6 and 12
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.
Time frame: At Week 6 and 12
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.
Time frame: At Week 6 and 12