Gingivitis, Plaque, Dental
Conditions
Keywords
Quigley-Hein Plaque Index, Modified Gingival
Brief summary
Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study
Interventions
DRUGcetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash
0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride
100 ppm F as sodium fluoride
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects, ages 18-70, inclusive. * Availability for the three-month duration of the clinical research study. * Good general health. * Initial modified gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index. * Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index. * Signed Informed Consent Form (Appendix C)
Exclusion criteria
* Presence of orthodontic bands. * Tumor(s) of the soft or hard tissues of the oral cavity. * Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone). * Five or more carious lesions requiring immediate restorative treatment. * Antibiotic use any time during the one-month period prior to entry into the study. * Participation in any other clinical study or test panel within the one month prior to entry into the study. * Dental prophylaxis during the past two weeks prior to baseline examinations. * History of allergies to oral care/personal care consumer products or their ingredients. * On any prescription medicines that might interfere with the study outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Gingival Index | baseline, 2 week, 6 week & 3 month | A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome. |
| Saxton Bleeding Index | baseline, 2 week, 6 week & 3 month | Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding. a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing |
| Modified Quigley-Hein Plaque Index | baseline, 2 week, 6 week & 3 month | Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome. |
Countries
Italy
Outcome results
None listed