The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.
This will be a single-center, 12-week, randomized, controlled, single blind (examiner only), 2-treatment arms, parallel group, stratified (by sex \[male/female\]) study, investigating gingival health and subgingival plaque reduction on healthy participants after twice daily using of an experimental mouthwash containing 0.085% weight/weight (w/w) CPC in combination with a commercially available regular toothpaste containing 0.243% w/w Sodium Fluoride (NaF) compared to a commercially available regular toothpaste containing 0.243% w/w NaF with no known anti-gingivitis nor anti plaque efficacy properties as control group. Approximately 132 participants (approximately 66 per group) will be randomized to ensure approximately 120 evaluable participants (approximately 60 per group) complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
Toothpaste containing 0.243% w/w NaF.
Mouthwash containing 0.085% w/w CPC.
Salus Research Inc
Fort Wayne, Indiana, United States
Number of Bleeding Sites (Overall) At Week 12
Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) before recording the number of gingival units which bleed. The number of bleeding sites is calculated as the number of evaluable tooth sites (having 2/3rds of the natural tooth surface gradable for assessment) with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame: Week 12
Number of Bleeding Sites (Interproximal) At Week 12
Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) before recording the number of gingival units which bleed. The number of bleeding sites is calculated as the number of evaluable tooth sites (having 2/3rds of the natural tooth surface gradable for assessment) with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame: Week 12
Number of Bleeding Sites (Overall) At Week 6
Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) before recording the number of gingival units which bleed. The number of bleeding sites is calculated as the number of evaluable tooth sites (having 2/3rds of the natural tooth surface gradable for assessment) with bleeding observed immediately on probing or within 30 seconds of probing.
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Time frame: Week 6
Number of Bleeding Sites (Interproximal) At Week 6
Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) before recording the number of gingival units which bleed. The number of bleeding sites is calculated as the number of evaluable tooth sites (having 2/3rds of the natural tooth surface gradable for assessment) with bleeding observed immediately on probing or within 30 seconds of probing.
Time frame: Week 6
Mean EBI (Overall) At Week 6 and Week 12
Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) and gingival bleeding will be 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. Lower score indicates improvement in the symptoms.
Time frame: Week 6 and Week 12
Mean EBI (Interproximal) At Week 6 and Week 12
Gingival bleeding will be 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 degree, while in contact with the sulcular epithelium. Each of six gingival areas (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) around each tooth will be assessed. All scorable teeth in one quadrant will be probed first (approximately 30 seconds) and gingival bleeding will be 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. Lower score indicates improvement in the symptoms.
Time frame: Week 6 and Week 12
Mean Modified Gingival Index (MGI) (Overall) At Week 6 and Week 12
The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). The MGI will be assessed for all scorable teeth (second permanent molar to second permanent molar in each arch) by an appropriately qualified examiner using 5-point scoring system 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 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 of gingivitis.
Time frame: Week 6 and Week 12
Mean MGI (Interproximal) At Week 6 and Week 12
The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). The MGI will be assessed for all scorable teeth (second permanent molar to second permanent molar in each arch) by an appropriately qualified examiner using 5-point scoring system, where 0= Absence of inflammation, 1= Mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit, 2= Mild inflammation; criteria as above 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 of gingivitis.
Time frame: Week 6 and Week 12
Mean Turesky Plaque Index (TPI) (Overall) at Week 6 and Week 12
TPI will be used to assess plaque on all gradable teeth. The plaque will be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores should be recorded buccally/labially (distal, body, mesial sites) and three scores lingually/palatally (distal, body, mesial sites). Disclosed plaque will be scored using 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 more 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.
Time frame: Week 6 and Week 12
Mean TPI (Interproximal) at Week 6 and Week 12
TPI will be used to assess plaque on all gradable teeth. The plaque will be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth (second molar to second molar). Three scores should be recorded buccally/labially (distal, body, mesial sites) and three scores lingually / palatally (distal, body, mesial sites). Disclosed plaque will be scored using 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.
Time frame: Week 6 and Week 12