An 8-Week, Randomized, Controlled, Examiner-Blind, Clinical Study to Evaluate the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentin Hypersensitivity in a Population of Dentin Hypersensitivity Sufferers
Overview
- Phase
- Not Applicable
- Intervention
- CSPS toothpaste
- Conditions
- Dentin Sensitivity
- Sponsor
- HALEON
- Enrollment
- 217
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste.
Detailed Description
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 5% CSPS toothpaste in a DH population. The clinical efficacy of the 5% CSPS 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 234 participants to investigational product (approximately 117 per treatment group) and to ensure approximately 210 evaluable participants complete the entire study (approximately 105 per treatment group).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant provision of signed and dated informed consent before any study procedures are performed.
- •Participant is male or female.
- •Participant is 18 to 65 years of age, inclusive, at the time of signing the informed consent.
- •Participant is willing and able to comply with the study visit schedule, product usage instructions, lifestyle restrictions and other study procedures.
- •Participant is in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in self-reported medical history, or upon oral examination, that would impact their safety or wellbeing, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements.
- •Screening (visit 1): Participant must have
- •History of tooth sensitivity lasting more than six months but not more than 10 years (self-reported).
- •Good general oral health, with a minimum of 20 natural teeth.
- •Minimum of 2 accessible, non-adjacent teeth (incisors, canines, premolars), in different quadrants, which meet all of the following criteria:
- •Exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR).
Exclusion Criteria
- •Participant is an employee of the investigator site directly involved in the conduct of the study, or an employee of the investigator site otherwise supervised by the investigator, or a member of their immediate family.
- •Participant is an employee of the sponsor directly involved in the conduct of the study or a member of their immediate family.
- •Female participant who is pregnant or intending to become pregnant during the study (self-reported).
- •Female participant who is breastfeeding (self-reported).
- •Participant with known or suspected intolerance or hypersensitivity to the study products, any of their stated ingredients or closely related compounds (self-reported).
- •Participant with a recent history (within the last year) of alcohol or other substance abuse (self-reported).
- •Participant is participating in or has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days of screening (Visit 1) or plans to participate in other studies (including non-medicinal studies) during this study.
- •Participant has participated in a tooth sensitivity study within 8 weeks of screening (Visit 1).
- •Participant is currently using an oral care product indicated for DH relief or care of sensitive teeth or has used an anti-sensitivity product within 8 weeks of screening (Visit 1). Participants will be required to bring their current oral care products to screening (Visit 1) for staff to verify the absence of known anti-sensitivity ingredients and sensitivity-related claims on the product packaging/label text.
- •Participant takes daily doses of medications/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with their perception of tooth sensitivity (for example, analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs).
Arms & Interventions
Test toothpaste
Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening), for approximately 56 days making sure to brush the sensitive areas of the two 'test teeth' carefully first. Participants who wish to rinse after brushing will be instructed to rinse with 10 milliliter (ml) water using graduated rinsing cup provided.
Intervention: CSPS toothpaste
Reference toothpaste (Negative control)
Participants will dose the toothbrush with a ribbon of toothpaste, across the full brush head and will brush the entire dentition thoroughly for at least 1-timed minute, twice daily (morning and evening) for approximately 56 days. Participants who wish to rinse after brushing will be instructed to rinse with 10 ml water using graduated rinsing cup provided.
Intervention: Regular fluoride toothpaste (Crest Cavity Protection)
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Day 56
Time Frame: Baseline (Day 0) and Day 56
Evaporative (air) sensitivity was assessed on facial surfaces of teeth by directing a 1 second application of air from standard dental syringe held perpendicular to tooth surface. Participant's response to the stimulus was evaluated using the Schiff sensitivity scale, an examiner-based index scored immediately following administration of the evaporative (air) stimulus. Score ranged from 0-3, where 0=Did not respond to air stimulation; 1=Responded to air stimulus but did not request discontinuation of stimulus; 2=Responded to air stimulus and requested discontinuation or moved from stimulus; 3=Responded to stimulus, considered stimulus to be painful, requested discontinuation of the stimulus. Schiff sensitivity score = Mean score for the two 'Test Teeth' selected at Baseline by the examiner. Lower score=low degree of sensitivity. Change from Baseline (Day 0) was calculated by subtracting Baseline score from Day 56 score. A negative change from Baseline indicated improvement.
Secondary Outcomes
- 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(Baseline (Day 0), Day 28 and Day 56)
- Adjusted Mean Change From Baseline in DHEQ Total Score (Section 2, Question Q1-34) at Days 28 and 56(Baseline (Day 0), Day 28 and Day 56)
- Adjusted Mean Change From Baseline in DHEQ Adaptation Domain Score (Section 2, Q5-16) at Days 28 and 56(Baseline (Day 0), 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(Baseline (Day 0), 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(Baseline (Day 0), Day 28 and Day 56)
- Adjusted Mean Change From Baseline in Tactile Threshold (Gram [g]) at Day 56(Baseline (Day 0) and Day 56)
- Adjusted Mean Change From Baseline in Schiff Sensitivity Score at Days 3, 7, 14 and 28(Baseline (Day 0), Days 3, 7, 14 and 28)
- Adjusted Mean Change From Baseline in Tactile Threshold (g) at Days 3, 7, 14 and 28(Baseline (Day 0), Days 3, 7, 14 and 28)
- Adjusted Mean Change From Baseline in DHEQ Restrictions Domain (Section 2, Q1-4) Score at Days 28 and 56(Baseline (Day 0), 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(Baseline (Day 0), Day 28 and Day 56)
- Adjusted Mean Change From Baseline in DHEQ Identity Domain (Section 2, Q30-34) Score at Days 28 and 56(Baseline (Day 0), Day 28 and Day 56)
- Adjusted Mean Change From Baseline in Global Oral Health (DHEQ Section 2, Q35) Score at Days 28 and 56(Baseline (Day 0), Day 28 and Day 56)