A clinical study to assess the efficacy of a new oral hygiene system in the reduction of gingivitis and dental plaque

INTERVENTION: Eligible participants will be stratified based on Baseline gingivitis score (MGI) (= 2.1 vs. > 2.1), whole mouth mean pre‐brushing plaque (RMNPI) (= 0.60 vs. > 0.60), number of bleeding sites (= 25.0 vs. > 25.0) and tobacco use. Within these strata, participants will be randomly assigned to either the new oral hygiene system group (consisting of a new interactive electrical toothbrush, antimicrobial toothpaste, mouth rinse and dental floss) or the Control group (regular toothbrush and toothpaste) using a balance and assignment procedure on site. This assignment process and the distribution of test products will be conducted in a protected area that will ensure blinding of the examiner to the identity of the test products. Oral Hygiene System: Participants will be instructed to download and install the App for their assigned brush on their mobile device and to use the App when brushing for the duration of the study. They will be instructed to brush their teeth with the assigned electrical toothbrush and the marketed dentifrice for 2 minutes twice a day (morning and evening) following the manufacturer’s usage instructions and to floss the whole mouth once daily for the duration of the study. After brushing, participants will be instructed to rinse with 20ml of the mouth rinse for 30 seconds. Control: Participants will be instructed to brush their teeth with the assigned products twice daily (morning and evening) in their customary manner. Participants will be instructed to rinse with water after brushing. Participants used only the treatment products in place of normal oral hygiene products for the duration of the study. Gingivitis measurements will be taken at: Baseline, Week 1, and Week CONDITION: Oral mild to moderate gingivitis ; Oral Health PRIMARY OUTCOME: ; 1. Gingival inflammation and bleeding measured by Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) at baseline, week 1, and week 12; 2. Dental plaque measured by Rustogi Modification of the Navy Plaque Index (RMNPI) at baseline (pre‐ and post‐brushing), week 1, and week 12 (both pre‐brushing only); SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: 1. Give written informed consent prior to study participation and be given a signed copy of their informed consent form 2. Be at least 18 years of age and typically use a manual toothbrush 3. Be in good general health as determined by the investigator/designee based on a review/update of their medical history 4. Possess a minimum of 16 natural teeth with facial and lingual scorable surfaces 5. Possess a smartphone which runs Android 7.0 to 10.0, or an iPhone that runs on iOS 11.0 to 13.0 and agree to download a toothbrushing app from the manufacturer of the assigned brush. The mobile device must support Bluetooth 4.2 (or higher)/Bluetooth Smart 6. Have a Baseline whole mouth mean MGI score of at least 1.75 but not more than 2.5 7. Have a Baseline whole mouth pre‐brushing RMNPI score of greater than 0.5 8. Have at le