A Randomized, Controlled, Examiner-Blind Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% w/w Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
Overview
- Phase
- Not Applicable
- Intervention
- Stannous fluoride toothpaste
- Conditions
- Gingivitis
- Sponsor
- HALEON
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis.
Detailed Description
This will be a single center, randomized, controlled, single blind (examiner blind), two-treatment arm, parallel study. Study participants will be over 18 years old, non-smokers, in good general health with clinically measurable levels of gingivitis that meet all study criteria at the Screening and Baseline visits. Approximately 160 participants (approximately 80 per group) will be randomized to ensure approximately 144 evaluable participants (approximately 72 per group) complete the study.
Investigators
Eligibility 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 is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
- •A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •A participant in good general 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 participant's ability to understand and follow study procedures and requirements.
- •Participant oral health that meets all the following:
- •At Screening (Visit 1):
- •Participant with at least 20 natural, permanent teeth.
- •Participant with at least 40 evaluable surfaces for MGI, BI, and TPI (An evaluable surface is defined as having two thirds of the natural tooth surface gradable for the selected clinical indices. The following will not be included in the evaluable surface count: third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices).
- •A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination.
- •At Baseline (Visit 2):
Exclusion Criteria
- •A 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 sponsor's employee directly involved in the conduct of the study or a member of their immediate family.
- •A 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.
- •A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or 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.
- •A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety.
- •A participant who is a pregnant female (self-reported) or is intending to become pregnant over the duration of the study.
- •A participant who is a breastfeeding female.
- •A participant who is known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •A participant who is unwilling or unable to comply with the lifestyle considerations.
- •Participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening.
- •Participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
Arms & Interventions
Test Product
Participants will be instructed to brush their teeth with full ribbon of toothpaste (0.454% w/w SnF2) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks.
Intervention: Stannous fluoride toothpaste
Negative Control
Participants will be instructed to brush their teeth with full ribbon of toothpaste (0.243% w/w Sodium fluoride) on head of toothbrush provided for at least one (timed) minute twice a day (morning and evening) for 12 weeks.
Intervention: Sodium fluoride toothpaste
Outcomes
Primary Outcomes
Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12
Time Frame: Baseline and Week 12
The NBS were calculated using the bleeding index (BI) assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Secondary Outcomes
- Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product)(Baseline and Week 12)
- Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product)(Baseline, Week 3 and Week 6)
- Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)(Baseline, Weeks 3, 6 and 12)
- Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)(Baseline, Weeks 3, 6 and 12)
- Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)(Baseline, Weeks 3, 6 and 12)
- Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)(Baseline, Weeks 3, 6 and 12)