Clinical Study to Collect and Analyze Dental Plaque and Oral Health Measures in a Population With High Plaque/Low Gingivitis and High Plaque/High Gingivitis

Korábbi kezelés

• Medical condition which requires premedication prior to dental visits/procedure.
• Dental prophylaxis within 30 days prior to study start.
• Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
• Use of chemotherapeutic oral care products within two weeks prior to study start.
• Participation in any other clinical study within 30 days prior to enrollment into this study.
• Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
• Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;

Más betegség

• 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.
• Active disease of the hard oral tissues.
• Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
• Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Egyéb

• Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
• Subjects with fixed or removable orthodontic appliances or removable partial dentures.
• Subjects who must receive dental treatment during the study dates.
• Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
• Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.

• Male or female volunteers at least 18 years of age and in general good health.
• Willing and able to understand and sign the informed consent form.
• Must have a whole mouth mean TPI score ≥ 3.25
• N=40 must have moderate-severe gingivitis (Whole Mouth Mean MGI≥2.5 or percent bleeding sites based on EBI ≥20%) and N=40 must have mild gingivitis (Whole Mouth Mean MGI≤2.5 and percent bleeding sites based on EBI\<20%)
• Must have at least two areas in the mouth with high plaque/low inflammation and two areas with high plaque/high inflammation
• Be willing to conform to the study protocol and procedures.
• Minimum of 20 natural teeth with scorable facial and lingual surfaces