The aim of this study is to investigate the stain removal efficacy of 2 experimental anti-dentin hypersensitivity (DH) dentifrices with four and eight weeks twice daily use. A daily use, regular fluoride dentifrice will be included as a reference dentifrice.
This will be a single-center, 8-week, randomized, controlled, single-blind, three treatment-arm, parallel design, stratified clinical study in healthy volunteers with a propensity to form dental stain. It has been designed to investigate changes in tooth stain and color, following twice-daily use of two experimental dentifrices, after four and eight weeks twice daily use; a regular fluoride dentifrice will be included as reference dentifrice. Sufficient participants will be screened to randomize approximately 300 participants to study treatment to ensure approximately 270 participants complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
5 percent (%) potassium nitrate (KNO3) dentifrice with 1% alumina and 5% sodium tripolyphosphate (STP).
5% KNO3 dentifrice with 1% alumina, 5% STP and 2% high cleaning silica.
Regular Fluoride Dentifrice.
All Sum Research Center (c/o Family & Cosmetic Dentistry)
Melbourne, Florida, United States
Change From Baseline in Mean Total Modified Lobene Stain Index (MLSI) Score at Week 8
Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third of area and light intensity stain, 2= Stain covering up to two thirds of area and moderate intensity stain, 3= Stain covering more than two thirds of area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 8 value.
Time frame: Baseline and Week 8
Change From Baseline in Mean Total MLSI Score at Week 4
Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score = Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third of area and light intensity stain, 2= Stain covering up to two thirds of area and moderate intensity stain, 3= Stain covering more than two thirds of area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the Week 4 value.
Time frame: Baseline and Week 4
Change From Baseline in Mean Total MLSI Score at Weeks 4 and 8
Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. MLSI score = Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third of area and light intensity stain, 2= Stain covering up to two thirds of area and moderate intensity stain, 3= Stain covering more than two thirds of area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score = Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.
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Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Mean VITA Shade Score (Examiner Assessed) at Weeks 4 and 8
Tooth shade (color) of the facial surfaces of the four central and lateral maxillary incisors was assessed by a trained clinical examiner using the VITA Bleached guide 3D-MASTER. It used a value-ranked ordered scale from 1 (the lightest) to 29 (the darkest). The shade level of each tooth surface was scored visually by the clinical examiner with reference to the Bleached guide, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Mean Total MLSI Score in Gingival Sites, Interproximal Sites and Body Sites at Weeks 4 and 8
Extrinsic dental stain area and its intensity were assessed at the specific tooth sites (Gingival site: Crescent-shaped band, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. Body Site: The remainder of the tooth surface). MLSI score= Area score multiplied by Intensity score. Area and intensity of extrinsic dental stain was scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third area and light intensity stain, 2= Stain covering up to two thirds area and moderate intensity stain, 3= Stain covering more than two thirds area and heavy intensity stain. MLSI score ranged from 0 to 9. Mean Total MLSI Score= Mean of MLSI score across all evaluable tooth surfaces for the participant with a range from 0 to 9, where a lower score indicated an improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.
Time frame: Baseline, Week 4 and Week 8
Change From Baseline in Mean MLSI (Area) and MLSI (Intensity) at Weeks 4 and 8
Extrinsic dental stain area and its intensity were assessed on the facial surfaces of the 6 maxillary and 6 mandibular anterior teeth and the lingual surfaces of the 6 mandibular anterior teeth. Area and intensity of extrinsic dental stain were scored separately for each tooth on the scale 0 to 3, where 0= area with no stain, 1= Stain covering up to one third of area and light intensity stain, 2= Stain covering up to two thirds of area and moderate intensity stain, 3= Stain covering more than two thirds of area and heavy intensity stain. Thus, MLSI score for both Area and Intensity ranged from 0 to 3, where lower score indicated improvement. Change from Baseline was calculated by subtracting the Baseline value from the value at indicated timepoints.
Time frame: Baseline, Week 4 and Week 8