Clinical Investigation Examining Plaque and Gingivitis Connected Toothbrush Compared to Non-Connected Toothbrush

A phase II randomized, single-center, two-cell, examiner-blind and parallel-group clinical study conducted in the Loma Linda, California area, to investigate the clinical efficacy of a connected power toothbrush as compared to a non-connected power toothbrush in reducing dental plaque and gingivitis as measured by the Rustogi Modification of the Navy Plaque Index and Löe and Silness Gingival Index over a 6-week period.

Inclusion criteria

• • Male and female subjects had to be between the ages of 18 and 70 (inclusive),
• • Subjects needed to be available for the duration (6 weeks) of the study,
• • Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
• • Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,
• • Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,
• • Subjects had to sign an Informed Consent form,
• • Subjects had to be in general good health and
• • Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.

Exclusion:

• • Medical condition which require pre-medication prior to dental visits/procedures,
• • The presence of partial removable dentures,
• • Subjects who had advanced periodontal disease (gum disease),
• • Five (5) or more decayed or untreated dental sites at screening (cavities),
• • Subjects with diseases of the soft or hard oral tissues,
• • Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),
• • Dry mouth as a result of a medication or medical condition,
• • Use of drugs that can currently affect salivary flow,
• • Use of antibiotics one (1) month prior to or during this study,
• • Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,
• • Chronic (>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),
• • Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,
• • Pregnant or breast-feeding women were excluded from the study,
• • Subjects who participated in any other clinical study in the month preceding this study,
• • Allergic to common dentifrice ingredients,
• • Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,
• • Immune compromised individuals (AIDS, immune suppressive drug therapy) and
• • History of infectious disease or other blood borne diseases (Hepatitis series, HIV).