Colgate Cavity Protection Toothpaste: Toothpaste with MFP/NaF (1450 F)
Study summary
Qualified subjects will be enrolled and randomized to either one of the three 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 three months and six months of product use. All subjects will be followed for adverse events throughout the study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Subjects, ages 18-70, inclusive.
* Availability for the six-month duration of the study.
* Good general health.
* Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
* Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
* Signed Informed Consent Form
Exclusion Criteria:
* 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
* Use of antibiotics any time during the one month 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.
* Received a dental prophylaxis in the two weeks prior to your initial examination.
* History of allergies to oral care/personal care consumer products or their ingredients.
* Having taken any prescription medicines that might interfere with the study outcome.
* If you with an existing medical condition which prohibits you from not eating or drinking for periods of up to 4 hours.
* Self-reported pregnant or breast feeding an infant.
* History of drug abuse
Primary outcome measure(s)
Lobene Modified Gingivitis Assessment — Baseline, 3 month, 6 month Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored
Saxton Gingival Bleeding Assessment — Baseline, 3 month, 6 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, 3 month, 6 month First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
