Last updated: 08/20/2020 12:30:08
Study to characterize the efficacy of a dual active dentifrice for the relief of dentin hypersensitivity
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Randomized Controlled Examiner-Blind Phase II Exploratory Clinical Study to Characterize the Efficacy Profile of an Experimental Dual Active Combination Dentifrice for the Relief of Dentin Hypersensitivity, in Subjects With Clinically Diagnosed Dentin Hypersensitivity
Trial description: This exploratory study will characterize the efficacy profile of an experimental dual active 5 percent (%) potassium nitrate/0.454% stannous fluoride dentifrice, compared to a single active 0.454% stannous fluoride desensitizing dentifrice, over an 8-week treatment period.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 3
Timeframe: Day 3
Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 7
Timeframe: Day 7
Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 14
Timeframe: Day 14
Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 28
Timeframe: Day 28
Mean Schiff Sensitivity Score (Average of the two Selected Test Teeth) at Day 56
Timeframe: Day 56
Mean Tactile Threshold (Average of the two Selected Test Teeth) at Baseline (Day 0)
Timeframe: Baseline (Day 0)
Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 3
Timeframe: Day 3
Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 7
Timeframe: Day 7
Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 14
Timeframe: Day 14
Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 28
Timeframe: Day 28
Mean Tactile Threshold (Average of the two Selected Test Teeth) at Day 56
Timeframe: Day 56
Number of Sensitive Teeth (Schiff Sensitivity Score Greater Than or Equal to [>=] 1) on Day 0 (Baseline)
Timeframe: Baseline (Day 0)
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 3
Timeframe: Day 3
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 7
Timeframe: Day 7
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 14
Timeframe: Day 14
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 28
Timeframe: Day 28
Number of Sensitive Teeth (Schiff Sensitivity Score >= 1) on Day 56
Timeframe: Day 56
Secondary outcomes:
Change from Baseline in Schiff Sensitivity Score at Day 56
Timeframe: Baseline (Day 0), Day 56
Change From Baseline (Day 0) in Tactile Threshold on Day 56
Timeframe: Baseline (Day 0), Day 56
Interventions:
Other: Potassium Nitrate
Other: Stannous Fluoride
Enrollment:
123
Observational study model:
Not applicable
Primary completion date:
2019-28-08
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dentin Hypersensitivity
Product
Not applicable
Collaborators
Not applicable
Study date(s)
May 2019 to August 2019
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
- Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
- Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
Inclusion and exclusion criteria
Inclusion criteria:
- Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures
- Participant in good general, oral and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history, or upon oral examination, or condition that would impact the Participant’s safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual’s ability to understand and follow study procedures and requirements
- Male participant able to father children or female participant of child-bearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 5 days after the last dose of assigned treatment
- AT VISIT 1 (Screening): Participant must have a) a self-reported history of dentin hypersensitivity (DH) lasting more than six months but not more than 10 years b) a minimum of 20 natural teeth c) a minimum of 2 accessible, non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, with clinically diagnosed DH; each tooth must meet the following criteria:
- exposed dentin due to facial/cervical erosion, abrasion or gingival recession (EAR)
- Modified Gingival Index (MGI) score = 0 adjacent to the test area (exposed dentin) only
- Clinical mobility less than or equal to (=<) 1
- DH, as evidenced by qualifying levels of tactile and evaporative air sensitivity (tactile threshold [=<] 20 gram (g); Schiff sensitivity score greater than or equal to [>=] 2)
- AT VISIT 2 (Baseline): Participant must have a minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), preferably in different quadrants, with DH, as evidenced by qualifying tactile and evaporative air sensitivity (each tooth must have a tactile threshold (=<) 20 g and a Schiff sensitivity score (>=) 2) at the Screening and Baseline visits
Exclusion criteria:
- Participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a GlaxoSmithKline Consumer Healthcare (GSK CH) employee directly involved in the conduct of the study or a member of their immediate family
- Participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation
- Participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, oral, psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study
- Participant with any condition which, in the opinion of the investigator or medically qualified designee, causes xerostomia
- Participant who is a pregnant female (as evidenced by a positive Urine Pregnancy Test [UPT] at Screening)
- Participant who is a breast-feeding female
- Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Participant with a recent history (within the last year) of alcohol or other substance abuse
- Participant who has participated in another tooth desensitizing treatment study within 8 weeks Screening
- Participant who has used an oral care product indicated for the relief of DH within 8 weeks of Screening (participant will be required to bring their current oral care products to the site in order to verify the absence of known anti-sensitivity ingredients)
- Participant who has had dental prophylaxis within 4 weeks of Screening
- Participant who has had a tooth bleaching procedure within 8 weeks of Screening
- Participant who has had treatment for periodontal disease (including surgery) within 12 months of Screening
- Participant who has had scaling or root planning within 3 months of Screening
- Participant with gross periodontal disease
- Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy
- Participant with a tongue or lip piercing or presence of multiple dental implants
- Participant with fixed or removable partial dentures
- Participant with fixed or removable orthodontic braces/bands or a fixed orthodontic retainer
- SPECIFIC DENTITION EXCLUSIONS FOR ‘TEST TEETH’: a) Tooth with evidence of current or recent caries or reported treatment of decay within 12 months of Screening b) Tooth with exposed dentin but with deep, defective or facial restorations c) Tooth with full crown or veneer d) Sensitive tooth with contributing etiologies other than erosion, abrasion or recession to exposed dentin e) Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
- Participant taking daily doses of medication/treatments which, in the opinion of the investigator or medically qualified designee, could interfere with the perception of pain (examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilizers, antidepressants, mood-altering and anti-inflammatory drugs)
- AT VISIT 1 (Screening): Participant who has taken antibiotics in the 2 weeks prior to the Screening visit
- AT VISIT 2 (Baseline): Participant who has taken antibiotics in the 2 weeks prior to the Baseline visit, during the acclimatization period
- Participant taking daily doses of a medication which, in the opinion of the investigator or medically qualified designee, is causing xerostomia
- Participant who requires antibiotic prophylaxis for dental procedures
- Participant who has previously been enrolled in this study
- Participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2019-28-08
Actual study completion date
2019-28-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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