The aim of this study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2) to improve gingival health and reduce plaque accumulation compared to a regular fluoride toothpaste (reference dentifrice) in participants with localized, plaque-induced, gingivitis.
This will be a single-center, 12 weeks, randomized, controlled, examiner-blind, 2 treatment arms, parallel group design clinical study to evaluate the efficacy of an experimental toothpaste containing 0.454% SnF2, used twice daily in reducing gingivitis and plaque accumulation in a population with clinically measurable levels of gingivitis. The clinical efficacy of the experimental toothpaste will be compared with a reference dentifrice, a commercially available, regular fluoride toothpaste. Additionally, unstimulated saliva samples will be collected from a sub-set of the randomized participants pre-brushing and at 15, 30, 60 and 120 minutes post-brushing which will be analyzed for tin concentration to investigate the retention of the stannous \[tin (II)\] ion within the oral cavity. Approximately 160 participants will be randomized to ensure approximately 144 evaluable participants complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
154
Toothpaste containing 0.454% SnF2, 0.3% zinc chloride (ZnCl2) and 1% alumina.
Regular fluoride toothpaste containing 0.76% sodium monofluorophosphate.
All Sum Research
Mississauga, Ontario, Canada
Mean Bleeding Index (BI) at Week 12
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI will be assessed on the facial and lingual gingival surfaces of each scorable tooth using a probe. The probe will be 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. Gingival bleeding will be scored on a 3-points scale with scores ranging from 0 to 2, where 0=Absence of bleeding on probing, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.
Time frame: Week 12
Mean BI at Week 6
The BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI will be assessed on the facial and lingual gingival surfaces of each scorable tooth using a probe. The probe will be 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. Gingival bleeding will be scored on a 3-points scale with scores ranging from 0 to 2, where 0=Absence of bleeding on probing, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.
Time frame: Week 6
Mean Number of Bleeding Sites (NBS) at Weeks 6 and 12
The NBS elicited on probing will be assessed using the BI assessment. Bleeding will be assessed on the facial and lingual gingival surfaces of each scorable tooth. The probe will be 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. The NBS for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.
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Time frame: Week 6 and Week 12
Mean Modified Gingival Index (MGI) at Weeks 6 and 12
The MGI is a non-invasive assessment which focuses on the visual symptoms of gingivitis (redness, texture, edema). MGI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, four sites per tooth and will be 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 texture of any portion of the marginal or papillary gingival unit, 2=Mild inflammation: criteria as \[1\] but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the 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 indicates improvement in the symptoms.
Time frame: Week 6 and Week 12
Mean Overall Turesky Plaque Index (TPI) at Weeks 6 and 12
The TPI is a non-invasive assessment of supra-gingival plaque accumulation. TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Dental plaque will first be disclosed with a plaque disclosing solution and disclosed plaque will be scored using 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 (\<) 1/3 of the tooth surface, 4=Plaque covering greater than or equal to (\>=) 1/3 but \< 2/3 of the tooth surface, 5=Plaque covering \>= 2/3 of the tooth surface. Lower score indicates improvement in the symptoms.
Time frame: Week 6 and Week 12
Mean Interproximal TPI at Weeks 6 and 12
The TPI is a non-invasive assessment of supra-gingival plaque accumulation. TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Dental plaque will first be disclosed with a plaque disclosing solution and disclosed plaque will be scored using 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 \< 1/3 of the tooth surface, 4=Plaque covering \>= 1/3 but \< 2/3 of the tooth surface, 5=Plaque covering \>= 2/3 of the tooth surface. Lower score indicates improvement in the symptoms.
Time frame: Week 6 and Week 12
Change from Baseline in Salivary Tin Concentration Pre- and Post-brushing at Weeks 6 and 12
Unstimulated saliva samples will be collected from participants pre- and post-brushing. The samples will be analyzed for tin concentration to investigate the retention of the stannous \[tin(II)\] ion within the oral cavity. Change from baseline in salivary tin concentration at indicated timepoints will be reported.
Time frame: Baseline, Week 6 and Week 12: Pre-brushing and at 15, 30, 60, 120 minutes post-brushing
Area Under the Curve (AUC) of Salivary Tin Concentration Post-brushing at Baseline, Weeks 6 and 12
Unstimulated saliva samples will be collected from participants pre- and post-brushing for the analysis of salivary tin concentration. The AUC \[pre-treatment, t=0 to 120 minutes\] values for the change from baseline in the log10 transformed salivary tin concentrations versus (vs) time will be reported.
Time frame: Baseline, Week 6 and Week 12: Pre-brushing and at 15, 30, 60, 120 minutes post-brushing
Salivary Tin Concentration Pre-brushing at Baseline, Weeks 6 and 12
Unstimulated saliva samples will be collected from participants pre- and post-brushing. The samples will be analyzed for tin concentration to investigate the retention of the stannous \[tin(II)\] ion within the oral cavity. Salivary tin concentration at the indicated timepoints will be reported.
Time frame: Baseline, Week 6 and Week 12