Dental caries prevention Oral Health Dental caries
Conditions
Interventions
Participants were stratified based on gender, baseline whole mouth mean plaque, age, and number of 'Focus Care' areas. Within strata, participants were randomly assigned equally to either the interact
Sponsors
Procter & Gamble
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provided written informed consent (including her/his guardians) and given a signed copy of the Informed Consent form 2. Aged 13-17 years 3. Typically uses a manual toothbrush 4. In good general health as determined by the investigator/designee based on a review of their medical history 5. Minimum of 16 natural teeth (excluding third molars) with facial and lingual scorable surfaces 6. At least one, but not more than four, 'Focus Care' areas (per investigator discretion) 7. Whole mouth average screening Turesky et al Modification of the Quigley Hein (TQHPI) score of =1.75 8. Agrees not to participate in any other oral care study for the duration of this study 9. Agrees to delay any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry performed on them at any time during the course of this study 10. Agrees to maintain their same regular at-home toothbrush and toothpaste between Screening and the Baseline visit 11. Agrees to refrain from using any non-study oral hygiene products for the duration of the study, except using their regular at-home toothbrush and toothpaste between the Screening and the Baseline visit 12. Agrees to return for their scheduled visits and follow all study procedures 13. Agrees to refrain from brushing their teeth and from performing any other oral hygiene procedures after their morning brushing (which is to be no later than 8 am) prior to the Screening visit and agree to follow these same restrictions prior to all visits 14. Agrees to refrain from eating, chewing gum, and drinking (except small sips of water up until 45 minutes prior to their appointment) for at least 2 hours prior to the Screening visit and agree to follow these same restrictions prior to all visits 15. Familiar with Android smartphone
Exclusion criteria
Exclusion criteria: 1. Several caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment 2. Active treatment for periodontitis 3. Smoking or any other type of tobacco use 4. Use of antibiotics or a chlorhexidine mouth rinse any time within the 2 weeks prior to the Screening visit 5. Fixed orthodontic appliances or removable partial dentures 6. Receiving a dental prophylaxis any time within the 4 weeks prior of the Screening visit 7. (Peri)oral piercings 8. Any disease or condition that could be expected to interfere with examination procedures or with the subject’s safe completion of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in afternoon dental plaque accumulation after morning brushing (not later than 8 am) via measures of Turesky Modified Quigley-Hein Index analysed for whole mouth means and in individual 'focus care areas' (areas with need for improvement of oral hygiene), conducted at baseline and at the end of the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in brushing time (compliance) from baseline to the end of the treatment phase. Brushing time was recorded by the clinical staff in a discreet way using a regular stopwatch. | — |
Countries
Germany
Outcome results
None listed