Trial Outcomes & Findings for A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation (NCT NCT06660069)

This study was conducted at a single center in United States of America.

A total of 199 participants were enrolled, 196 participants were randomized to treatment groups: 65 participants to the toothpaste/mouthwash group, 65 participants to the reference toothpaste group, and 66 participants to the negative control group. A total of 183 randomized participants subsequently completed the study.

A Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste With a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

Gingival bleeding was assessed according to the expanded bleeding index (EBI), by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth were assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale ranging from 0 to 2, where 0 equal to (=) no bleeding after 30 seconds; 1=bleeding observed within 30 seconds of probing; 2=bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale 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. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms.

The MGI assessment was a non-invasive evaluation which focused on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; 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 indicated improvement in the symptoms.

The MGI assessment was a non-invasive evaluation which focused on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; 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 indicated improvement in the symptoms.

The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/ palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was 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 millimeter\[mm\]) 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 indicated improvement in the symptoms.

The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was 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 \<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 indicated improvement in the symptoms.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. The NBS for each participant was calculated as the number of evaluable tooth sites (having two-thirds of the natural tooth surface gradable for the assessment) with bleeding observed immediately on probing or within 30 seconds of probing.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale 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. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms.

Gingival bleeding was assessed according to the EBI, by inserting a periodontal probe into the gingival crevice and sweeping from distal to mesial around the tooth at an approximate angle of 60 degrees, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth was assessed. Presence/absence of gingival bleeding was assessed for 30 seconds after probing and scored on a 3-points scale 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. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms.

The MGI assessment was non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; 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 indicated improvement in the symptoms.

The MGI assessment was non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). MGI was assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth (second permanent molar to second permanent molar in each arch) and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in colour, little change in colour; 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 indicated improvement in the symptoms.

The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores was recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was 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 \<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 indicated improvement in the symptoms.

The TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores were recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites) and mean was calculated. The plaque was first be disclosed using a plaque disclosing dye solution and the disclosed plaque was 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 \<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 indicated improvement in the symptoms.