The aim of this study is to confirm the clinical Dentin Hypersensitivity (DH) efficacy of a 0.454 percent (%) Stannous Fluoride (SnF2) toothpaste.
This will be a single center, 8-week, randomized, controlled, examiner-blind, 2-treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected 'test teeth') clinical study to evaluate the anti-sensitivity efficacy of a 0.454% SnF2 toothpaste in a DH population. The clinical efficacy of the 0.454% SnF2 toothpaste (test toothpaste) will be compared with that of a reference toothpaste, a commercially available, regular fluoride toothpaste with no known anti-sensitivity properties (negative control). Sufficient participants will be screened to randomize approximately 110 participants to investigational product (approximately 55 per treatment group) and to ensure approximately 100 evaluable participants complete the entire study (approximately 50 per treatment group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
111
Toothpaste containing 0.454 % weight/weight (w/w) SnF2
Regular fluoride toothpaste containing 1100 parts per million (ppm) fluoride.
Salus Research
Fort Wayne, Indiana, United States
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged 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, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 56 score. A decrease in Schiff sensitivity score indicated an improvement.
Time frame: Baseline and Day 56
Adjusted Mean Change From Baseline in Tactile Threshold at Day 56
Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram (g). At baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at baseline. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 56 value.
Time frame: Baseline and Day 56
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 28
Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. Participant's response to the stimulus was evaluated by the examiner using the Schiff sensitivity scale immediately following administration of the evaporative air stimulus. Score ranged 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, requests discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at baseline by the examiner. Change from baseline was calculated by subtracting baseline score from Day 28 score. A decrease in Schiff sensitivity score indicated an improvement.
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Time frame: Baseline and Day 28
Adjusted Mean Change From Baseline in Tactile Threshold at Day 28
Tactile sensitivity was assessed by participant's response to tactile stimulus after the stimulation of the 2 test teeth selected at Baseline by the examiner. A constant pressure probe (Yeaple probe) was used for stimulation. The probe tip was placed perpendicular to the facial surface of tooth and drawn slowly across the exposed dentine. After each application, the participants were asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses was recorded as the tactile threshold in gram. At baseline, the upper force setting was 20g. Tactile threshold (g) was derived as the mean value for the two 'Test Teeth' selected by the examiner at baseline. An increase in tactile threshold indicated an improvement in sensitivity. Change from baseline was calculated by subtracting baseline value from Day 28 value.
Time frame: Baseline and Day 28
Adjusted Mean Change From Baseline in Impact on Everyday Life (Section 1 of Dentin Hypersensitivity Experience Questionnaire [DHEQ-48], Question [Q]7-9) at Days 28 and 56
DHEQ section 1, questions 7-9 were about teeth sensation and its impact on everyday life. Participants scored Q7 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q8 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q9 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). Thus, the total score ranged from 3 to 30; where the lower score indicated less sensitivity and less impact on everyday life. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Q1-34) at Days 28 and 56
The DHEQ was a condition-specific measure of Oral Health-related Quality of Life (OHrQoL) in relation to DH which consisted of a total of 34 questions in section 2 grouped into 5 separate domains: Restrictions(Q1-4), Adaptation(Q5-16), Social Impact(Q17-21), Emotional Impact(Q22-29), and Identity(Q30-34), each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 34 to 238; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56
Restrictions domain in DHEQ evaluated the ways in which any sensations in teeth affected participant's daily life. This consisted of 4 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 4 to 28; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56
Adaptation domain in DHEQ evaluated 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This consisted of 12 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 12 to 84; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in DHEQ Social Impact Domain (Section 2, Q17-21) Score at Days 28 and 56
Social Impact domain in DHEQ evaluated the way the sensations affected participants when they were with other people or in certain situations. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in DHEQ Emotional Impact Domain (Section 2, Q22-29) Score at Days 28 and 56
Emotional Impact Domain in DHEQ evaluated the way the sensations in participant's teeth made them feel. This consisted of 8 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 8 to 56; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56
Identity Domain in DHEQ evaluated what the sensations in participant's teeth meant for them. This consisted of 5 questions each scored using a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranged from 5 to 35; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56
Global Oral Health was evaluated using a single question which asked about the overall health of participant's mouth, teeth, and gums. The scale ranged from 1 (excellent) to 6 (Very poor), where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoints minus score at baseline.
Time frame: Baseline, Day 28 and Day 56
Adjusted Mean Change From Baseline in Effect on Life Overall (DHEQ Section 2, Q36-39) Score at Days 28 and 56
Effect on life was evaluated using 4 questions which asked how much the sensations in teeth affected participant's life overall. The scale ranged from 0 (not at all) to 4 (Very much) and thus, the total score ranged from 0 to 16; where the lower score indicated improvement in the symptoms. Change from baseline was calculated as score at indicated post-baseline timepoint minus score at baseline.
Time frame: Baseline, Day 28 and Day 56