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

Study Overview
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Brief Summary
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The objective of this clinical research study is to assess plaque and gingivitis reductions of Connected Toothbrush compared to Non-Connected Toothbrush over a six-week clinical study.

Detailed Description
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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.

Official Title
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Clinical Investigation Examining Plaque and Gingivitis Reductions of Connected Toothbrush Compared to Non-Connected Toothbrush: a Six-week Clinical Study in California

Conditions
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Gingivitis, Plaque, Dental

Intervention / Treatment
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* Device: Electric Toothbrush
* Other: oral health care application


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental Toothbrush 1<br>1. A connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. | Device: Electric Toothbrush<br>* Electric Toothbrush used to remove dental plaque and resolve gingivitis<br>Other: oral health care application<br>* phone application that shows the user brushing efficiency real time<br>|
| Active Comparator: Experimental Toothbrush 2<br>2. A non-connected power toothbrush; brushed twice daily (morning and evening) for two (2) minutes, with Colgate Cavity Protection Toothpaste; Oral. | Device: Electric Toothbrush<br>* Electric Toothbrush used to remove dental plaque and resolve gingivitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mean dental plaque | Reduction in plaque measurement is served as primary efficacy variable toothbrush for 6 weeks for each subject. | 3 and 6 weeks of product use | 
| change in mean gingivitis | gingivitis measurement is served as secondary efficacy variable | 3 and 6 weeks of product use |