This exploratory study will investigate the effect of long-term management of Dentine Hypersensitivity (DH) by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene (as measured by supra-gingival plaque accumulation), with associated changes in gingival health.
This is a single center, non-comparative design study to investigate the effect of long-term management of DH by use of a sensitivity toothpaste on selected oral health parameters, such as changes in oral hygiene, with associated changes in gingival health. Sufficient participants will be screened to ensure approximately 70 eligible participants get allocated the study toothpaste in order to ensure that approximately 60 participants complete the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Marketed toothpaste containing 5 percent (%) weight by weight (w/w) NovaMin / 1426 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
Intertek CRS Ltd
Ellesmere Port, Cheshire, United Kingdom
Change From Baseline in Schiff Sensitivity Score
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 and up to Week 24
Change From Baseline in Tactile Threshold
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 and up to Week 24
Change From Baseline in Labelled Magnitude Scales (LMS) Score
The tooth sensitivity questionnaire will be used to describe the overall tooth sensitivity experienced by the participant. Participants will indicate whether they have felt tooth sensitivity during the previous 24 hours. Participants who indicate they did feel tooth sensitivity will complete the remainder of the questionnaire and rate the intensity, duration, tolerability and descriptive quality of their tooth sensitivity using the four individual 100 millimeter (mm) LMS. Participants will mark each scale to indicate the best description of their sensitivity and the marked-off line segment will be measured in 'mm'. Lower scores indicate an improvement in sensitivity. Change from Baseline will be calculated by subtracting Baseline score from the score at the indicated timepoints.
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Time frame: Baseline and up to Week 24
Change From Baseline in Turesky Plaque Index (TPI)
TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. Disclosed plaque will be scored on a scale ranging from 0-6, where 0= No plaque, 1= Slight flecks of plaque at the cervical margin of the tooth, 2= Thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3= Band of plaque wider than 1 mm but covering less than (\<)1/3 of the area, 4= Plaque covering at least 1/3 but less than 2/3 of the area, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicates improvement in the symptoms. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Time frame: Baseline and up to Week 24
Change From Baseline in Modified Gingival Index [MGI]
The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis. It will be assessed on the facial and lingual surfaces of each scorable tooth using a 5-point scale ranging from 0 to 4, where 0= absence of inflammation 1= mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit. 2= mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit. 3= moderate inflammation; glazing, redness, oedema, and/or hypertrophy of the marginal or papillary gingival unit. 4= severe inflammation; marked redness, oedema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicates improvement in the symptoms. Change from Baseline will be calculated by subtracting the Baseline score from the score at the indicated timepoints.
Time frame: Baseline and up to Week 24
Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score
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 and up to Week 24