Plaque, Dental
Conditions
Keywords
plaque gingivitis
Brief summary
The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.
Interventions
DRUGfluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product
PARTICIPANTS WILL USE A EUGENOL BASED product PRIOR TO TOOTHBRUSHING
DRUGfluoride toothpaste containing 1450 ppm of MFP in a PCC base
toothbrushing 2x a day for 2 minutes each time
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* You must provide consent to participate by signing this informed consent form. * Available for the two(2) week study duration. * You must be at least eighteen(18) years old and not older than seventy(70) years of age. * You must not smoke. * You must be in good general health for participation in the study, based on the opinion of the study investigator. * You must have at least 20 natural permanent teeth. * Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner. * You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire. * You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
Exclusion criteria
* Medical condition which requires premedication prior to dental visits/procedures. * Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations. * Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months. * Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care. Abnormalities/diseases of the soft or hard oral tissues. * Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring) * Current smokers and/or tobacco users and/or a history of alcohol or drug abuse. * Use of drugs that can affect salivary flow. * Use of antibiotics one (1) month prior to study entry and/or during participation in this study. * Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion. * Self-reported pregnancy and/or breastfeeding. * Current Participation in another clinical study or during the month prior to this clinical study entry. * Known allergies and/or reactions to common dentifrice ingredients. * Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits. * Immunocompromised conditions (AIDS, immunosuppressive drug therapy). * Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Turesky Modification of the Quigley & Hein Plaque Index | baseline and six months | Reduction in plaque measurement is served as primary efficacy variable are served. The scoring scheme for the Turesky Modification of the Quigley-Hein dental plaque index is as follows: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire | six months | self-reported questionnaires are served as secondary efficacy variable. |
Countries
Germany
Outcome results
None listed