The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients). One experimental formulation to be used either once daily or twice daily, and the second experimental formulation and placebo, to be used twice daily for the treatment of dentinal hypersensitivity.
This study will be an 8 week, randomized, examiner blind four treatment arm, parallel group design, stratified (by Baseline Schiff Sensitivity Score), in participants that meet all the criteria at the Screening and Baseline visits. Approximately 280 participants will be screened to randomize approximately 115 participants (to achieve approximately 30 participants to complete in each treatment group for twice daily usage and 15 to complete for the once daily usage group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
118
3.0% weight by weight (w/w) KNO3 with 217 parts per million (ppm) sodium fluoride.
2.0% w/w HPC mouthwash with 217ppm sodium fluoride.
0% w/w KNO3 with 217ppm sodium fluoride.
proDERM
Harburg, Free and Hanseatic City of Hamburg, Germany
Change From Baseline in Schiff Sensitivity Score at Weeks 4, 6 and 8
Evaporative (air) sensitivity will be assessed by the participant's response to an evaporative (air) stimulus administered by the clinical examiner. Participant response will be evaluated immediately following application of the stimulus using the Schiff sensitivity scale (0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of stimulus). A decrease in Schiff sensitivity score indicates improvement. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
Time frame: Baseline, Weeks 4, 6 and 8
Change From Baseline in Tactile Threshold at Weeks 4, 6 and 8
Tactile sensitivity will be assessed by the participant's response to a tactile stimulus administered by the clinical examiner using a constant pressure probe (Yeaple probe). After each application of the stimulus, the participant will be asked to indicate whether they experienced any pain or discomfort (yes/no response). The pressure setting with two consecutive 'yes' responses will be recorded as the tactile threshold in gram. An increase in tactile threshold (gram) indicates improvement. Change from Baseline will be calculated by subtracting Baseline value from the value at the indicated timepoints.
Time frame: Baseline, Weeks 4, 6 and 8
Change From Baseline in Individual Questions Score from Dentine Hypersensitivity Experience Questionnaire (DHEQ) at Weeks 4 and 8
The DHEQ is used to measure how Dentin Hypersensitivity (DH) affects participants quality of life. Participant will respond to three individual questions from section 1 of DHEQ- 1. How intense are the sensations? 2. How bothered are you by any sensations? 3. How well can you tolerate sensations? The response to the questions will be scored using a 10-point scale ranging from 1 to 10, where lower score indicates a less severity of symptoms. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
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Time frame: Baseline, Weeks 4 and 8
Change From Baseline in DHEQ Total Score at Week 4 and 8
The DHEQ is used to measure how DH affects participants quality of life. Section 2 has 34 questions in grouped into 5 domains (Restrictions, Adaptation, Social Impact, Emotional Impact, and Identity). Participants will score each question using a 7-point scale ranging from 1 to 7, where 1= strongly disagree, 2=disagree, 3=disagree a little, 4=neither agree nor disagree, 5=agree a little, 6=agree, and 7=strongly agree. The total score will be derived from the sum of scores across all domains and it ranges from 34 to 238. A lower score indicates a better quality of life regarding DH. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Time frame: Baseline, Weeks 4 and 8
Change From Baseline in Global Oral Health Score at Week 4 and 8
Global Oral Health is evaluated using a single question of DHEQ. Participants will rate the overall health of their mouth, teeth, and gums using a 6-point scale ranging from 1 to 6 where 1=excellent, 2=very good, 3=good, 4=fair, 5=poor, and 6=very poor. Lower score indicates better oral health. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Time frame: Baseline, Weeks 4 and 8
Change From Baseline in Effect on Life Overall Score at Week 4 and 8
Effect on life will be evaluated using 4 questions of DHEQ about how much the sensation in teeth affects participant's life overall. Participants will score each question on a 5-point scale ranging from 0 to 4 where 0=not at all, 1=a little, 2=somewhat; 3=quite a bit, and 4=very much. Thus, the total score ranges from 0 to 16, where lower score indicates less effect of sensations on participant's life overall. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Time frame: Baseline, Weeks 4 and 8