The aim of this exploratory clinical study is to investigate the tooth whitening potential, Dentin Hypersensitivity (DH) efficacy, and oral tolerability of two experimental toothpastes in a DH population with appropriate tooth shade and dental stain levels for the evaluation of whitening performance.
This will be a single center, randomized, controlled, examiner-blind, 3-treatment arm, stratified (Baseline mean VITA Bleached Guide 3D-MASTER score), parallel design, clinical study in healthy participants, aged 18-65 years inclusive, with sufficient tooth discoloration/surface stain to evaluate the whitening potential of the experimental formulations, and self-reported/clinically diagnosed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be randomized to one of three study toothpastes. Approximately 105 qualifying participants will be stratified and randomized to study treatment (approximately 35 participants per treatment group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
105
Toothpaste containing Potassium nitrate
Toothpaste containing Potassium nitrate
Regular fluoride toothpaste
Silverstone Research Group
Las Vegas, Nevada, United States
RECRUITINGMean VITA Shade Score at Baseline, Weeks 1, 2, 4 and 8
Tooth color of the facial surfaces of the six anterior maxillary teeth will be visually assessed using the VITA Bleachedguide 3D-MASTER shade guide. It consists of a value-ranked ordered scale from 1 (lightest) to 29 (darkest). The shade of each assessable tooth surface/region will be scored by the clinical examiner with reference to the guide, where lower score indicates improvement.
Time frame: Baseline, Weeks 1, 2, 4 and 8
Mean Total Modified Lobene Stain Index (MLSI) Score at Baseline, Weeks 1, 2, 4 and 8
Dental stain will be visually assessed for the facial surfaces of the teeth (incisors and canines) using the MLSI. For each tooth surface assessed, Area (A) and Intensity (I) of dental stain will be scored separately on the scale of 0 to 3 and the mean total score will be 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 ranging from 0 to 9, where lower score indicates improvement.
Time frame: Baseline, Weeks 1, 2, 4 and 8
Schiff Sensitivity Score at Baseline, Week 4 and Week 8
Evaporative (air) sensitivity will be assessed by participant's response to an evaporative (air) stimulus after stimulation of 2 selected test teeth. Response of participant will be scored using Schiff sensitivity scale which ranges from 0-3, where 0=Does not respond to air stimulation; 1=Responds to air stimulus but does not request discontinuation of stimulus; 2=Responds to air stimulus and requests discontinuation or moves from stimulus; 3=Responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The lower score indicates improvement.
Time frame: Baseline, Week 4 and 8
Tactile Threshold at Baseline, Week 4 and Week 8
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The tactile sensitivity will be assessed by administrating a constant pressure using a Yeaple probe. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for 2 selected test teeth will be determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutives 'yes' responses will be recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth.
Time frame: Baseline, Week 4 and 8