Clinical Study to Investigate the Antihypersensitivity Efficacy of a Novel Dentifrice
Purpose
The aim of this clinical study is to demonstrate the superior antihypersensitivity efficacy of a novel stannous fluoride (SnF2) and potassium nitrate (KNO3) dentifrice (Investigational Product), compared to SnF2 only, KNO3 only and Vehicle dentifrices, after 8 weeks twice daily use.
Condition
- Dentin Hypersensitivity
Eligibility
- Eligible Ages
- Between 12 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Provision of signed and dated informed consent document (and assent document, if appropriate) - Participant is biologically male or female. - Participant is 12 to 65 years of age, inclusive, at the time of signing the consent/assent form. - 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 well-being, or the outcomes of the study, if they were to participate in the study, or affect their ability to understand and follow study requirements. - Participant has a history of tooth sensitivity lasting more than six months but not more than 10 years (self-reported). - Participant has a minimum of 2 non-adjacent teeth (incisors, canines or premolars), in different quadrants, with exposed dentin due to facial/cervical erosion, abrasion or gingival recession, and clinically confirmed dentin hypersensitivity to tactile and evaporative (air) stimuli at Screening and Baseline.
Exclusion Criteria
- Female participant who is pregnant at Screening and Baseline, or is intending to become pregnant during the study. - Female participant who is breastfeeding. - Participant with known or suspected intolerance or hypersensitivity to any of the study products, any of their stated ingredients or closely related compounds. - Participant is participating in, or has participated in, other studies (including non-medicinal studies) involving an Investigational Product within 30 days of Screening 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. - Participant is currently using an oral care product indicated for dentin hypersensitivity relief or care of sensitive teeth or has used an antihypersensitivity oral care product within 8 weeks of Screening. - 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. - Participant has had professional tooth de-sensitising treatment within 8 weeks of Screening. - Participant has had a tooth bleaching procedure within 8 weeks of Screening. - Participant has had dental prophylaxis within 4 weeks of Screening. - Participant with evidence of gross intra-oral neglect or the need for extensive dental therapy. - Participant with evidence of current/recent active dental caries or treatment for decay within 12 months of Screening. - Participant who, in the opinion of the investigator or dentally qualified designee, is at high risk of dental caries. - Participant with specific dentition exclusions for 'Test Teeth'. - Participant has taken antibiotics in the 2 weeks prior to Screening or Baseline.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Test Dentifrice |
Participants will be instructed to dose the toothbrush head with the Test Dentifrice (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
|
|
Active Comparator Reference Dentifrice 1 |
Participants will be instructed to dose the toothbrush head with Reference Dentifrice 1 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
|
|
Active Comparator Reference Dentifrice 2 |
Participants will be instructed to dose the toothbrush head with Reference Dentifrice 2 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
|
|
Placebo Comparator Reference Dentifrice 3 |
Participants will be instructed to dose the toothbrush head with Reference Dentifrice 3 (at least a 1-inch strip of product), then brush the teeth thoroughly for at least 1-minute, twice a day (morning and evening) for approximately 8 weeks, making sure to brush all sensitive areas of the teeth. |
|
Recruiting Locations
All Sum Research Limited
Melbourne 4163971, Florida 4155751 32935
Melbourne 4163971, Florida 4155751 32935
Contact:
John T Gallob
John T Gallob
Salus Research, Inc.
Fort Wayne 4920423, Indiana 4921868 46825
Fort Wayne 4920423, Indiana 4921868 46825
Contact:
Jeffery L Milleman
Jeffery L Milleman
Silverstone Research
Las Vegas 5506956, Nevada 5509151 89146
Las Vegas 5506956, Nevada 5509151 89146
Contact:
Pejmon Amini
Pejmon Amini
More Details
- Status
- Recruiting
- Sponsor
- HALEON
Detailed Description
This will be a multi-center, randomized, controlled, double-blind, 4-treatment arm, stratified, parallel design, Phase III clinical study in healthy participants, aged 12-65 years inclusive, with self-reported and clinically confirmed dentin hypersensitivity. Participants who meet the required study criteria at Screening and Baseline will be stratified and randomized to one of four study dentifrices. Approximately 630 qualifying participants will be randomized to study treatment (approximately 180 participants each to the SnF2 and KNO3 dentifrice, the SnF2 dentifrice and the KNO3 dentifrice; approximately 90 participants to the Vehicle dentifrice). Dentin hypersensitivity will be clinically assessed at Screening and Baseline, and after 3 days, 1 week, 2 weeks, 4 weeks and 8 weeks treatment (7 study visits).