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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
159
0.454% w/w SnF2
0.243% w/w Sodium fluoride
Salus Research
Fort Wayne, Indiana, United States
Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at 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.
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product)
The NBS were calculated using the 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 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.
Time frame: Baseline and Week 12
Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product)
The NBS were calculated using the 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 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 each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
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Time frame: 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)
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution, disclosed plaque was then scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Overall TPI score for each participant=Sum of index values over all evaluable tooth sites (sites scored as 0 to 5), divided by the number of evaluable tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Time frame: 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)
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Interproximal TPI score for each participant=Sum of index values over all evaluable distal and mesial tooth sites, divided by the number of evaluable distal and mesial tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Time frame: Baseline, Weeks 3, 6 and 12
Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. Gingival bleeding was scored on a 3-points scale with scores ranging from 0 to 2, where 0=No bleeding after 30 seconds, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. BI score for each participant=sum of index values over all evaluable tooth sites (those scored as 0, 1, or 2), divided by the number of evaluable tooth sites. Lower score=better outcome. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline=Day 0. A negative change from Baseline indicated improvement in gingival condition.
Time frame: 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)
MGI assessment is a non-invasive evaluation which focuses on visual symptoms of gingivitis (example, redness, texture, edema). MGI was assessed on facial and lingual surfaces of each scorable tooth and scored on 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 marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving entire marginal or papillary gingival unit; 3=Moderate inflammation; glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit; 4=Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline \[Day 0\] value. A negative change from Baseline indicated improvement in symptoms.
Time frame: Baseline, Weeks 3, 6 and 12