The main aim of this study is to investigate the ability of an experimental dentifrice containing 5 percent (%) potassium nitrate (KNO3), 1% alumina and 5% sodium tripolyphosphate (STP), to maintain tooth color and reduce extrinsic dental stain accumulation following peroxide tooth bleaching compared to a regular fluoride dentifrice.
This will be a randomized, single-blind, single-center, controlled, two arm, stratified (clinically diagnosed dentine hypersensitivity \[DH\] \[Yes/No\]), parallel group study to evaluate the efficacy of an experimental dentifrice containing 5% KNO3, 1% alumina and 5% STP, to maintain tooth color and reduce the accumulation of extrinsic tooth stain following peroxide tooth bleaching compared to a regular fluoride-containing dentifrice. The study will recruit generally healthy participants who wish to undergo peroxide tooth bleaching. Sufficient participants will be screened to randomize approximately 160 participants to study treatment to ensure approximately 128 evaluable participants complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
Dentifrice containing 5% weight by weight (w/w) KNO3, 1% alumina, 5% STP and 1150 ppm fluoride as sodium fluoride.
Dentifrice containing 1150 ppm fluoride as sodium fluoride.
Silverstone Research Group
Las Vegas, Nevada, United States
Adjusted Mean VITA Shade Score at 24 Weeks After Tooth Bleaching
Tooth color of the facial surfaces of the six anterior maxillary teeth was assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It consisted of 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 Bleachedguide, where lower score indicated improvement.
Time frame: At Week 24 after tooth bleaching
Adjusted Mean VITA Shade Score at 12 Weeks After Tooth Bleaching
Tooth color of the facial surfaces of the six anterior maxillary teeth was assessed by a single, trained clinical examiner using the VITA Bleachedguide 3D-MASTER. It consisted of 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 Bleachedguide, where lower score indicated improvement.
Time frame: At Week 12 after tooth bleaching
Adjusted Mean Total Modified Lobene Stain Index (MLSI) Score at 12 and 24 Weeks After Tooth Bleaching
Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) and intensity (I) of extrinsic dental stain were scored separately for each tooth on the scale of 0 to 3 and the mean total score was presented, 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. Total MLSI score = Area score multiplied by Intensity score and ranged from 0 to 9, where lower score indicated improvement.
Time frame: At Week 12 and Week 24 after tooth bleaching
Adjusted Mean MLSI Score at 12 and 24 Weeks After Tooth Bleaching in Gingival Sites, Interproximal Sites and Body Sites
Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. The facial surface of each assessable tooth was divided into individual sites. The gingival site was defined as a crescent-shaped band, approximately 2 millimeters wide, adjacent to the free margin of the gingiva and extending to the crest of the interdental papillae of the adjacent teeth. The remainder of the tooth surface was called as body site. Area (A) and intensity (I) of extrinsic dental stain were scored separately for each tooth on the scale of 0 to 3 and the mean score was presented, 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. Total MLSI score = Area score multiplied by Intensity score and ranged from 0 to 9, where lower score indicated improvement.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At Week 12 and Week 24 after tooth bleaching
Adjusted Mean MLSI (Area) Score at 12 and 24 Weeks After Tooth Bleaching
Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Area (A) of extrinsic dental stain was scored separately for each tooth on the scale of 0 to 3, where 0=area with no stain, 1=Stain covering up to one third of area, 2=Stain covering up to two thirds of area, 3=Stain covering more than two thirds of area. Total score ranged from 0 to 3, where lower score indicated improvement.
Time frame: At Week 12 and Week 24 after tooth bleaching
Adjusted Mean MLSI (Intensity) Score at 12 and 24 Weeks After Tooth Bleaching
Extrinsic dental stain was assessed on the facial surfaces of the 6 maxillary anterior teeth using the MLSI. Intensity (I) of extrinsic dental stain was scored separately for each tooth on the scale of 0 to 3, where 0=no stain, 1=light intensity stain, 2=moderate intensity stain, 3=heavy intensity stain. Total score ranged from 0 to 3, where lower score indicated improvement.
Time frame: At Week 12 and Week 24 after tooth bleaching