A clinical study among adolescents comparing an interactive electric toothbrush with smartphone app to a manual toothbrush

Not Applicable

Completed

• Conditions: Dental caries prevention; Oral Health; Dental caries

• Registration Number: ISRCTN10112852
• Lead Sponsor: Procter & Gamble

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30075780

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-07-18
• Study Start: 2018-06-18
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified