A clinical study to assess the effectiveness of an electric toothbrush to reduce dental plaque and its effects on the users’ behavior

Not Applicable

Completed

• Conditions: Evidence of dental plaque; Oral Health

• Registration Number: ISRCTN99464691
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37816615/ (added 08/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-16
• Study Start: 2023-04-24
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

In order to be included in the study, each subject must:
1. Be at least 18 years of age
2. Provide written informed consent prior to participation and receive a signed copy
3. Usually use an Oral-B power toothbrush handle (O/R)
4. Be in good general health as determined by the investigator/designee based on a review/update of their medical history
5. Possess a minimum of 16 scorable teeth with facial and lingual scorable surfaces
6. 2nd molars upper and lower from both sides must be present and have at least four upper and lower front teeth
7. The distribution of the teeth needs to be balanced between the quadrants to guarantee a good positioning during imprint taking and repositioning of the final imprint
8. Have a screening whole mouth mean TQHPI score of =1.75
9. Refrain from all oral hygiene procedures for approximately 24 hours prior to this visit and agree to follow this same restriction prior to all visits
10. Refrain from eating, drinking*, chewing gum and any tobacco use for at least 2 hours prior to this visit and agree to follow these same restrictions prior to all visits *Allowed small sips of water up until 45 min prior to their appointment
11. Agree not to participate in any other oral care study for the duration of this study
12. Agree to delay any elective dentistry, including dental prophylaxis, until study completion and to report any non-study dentistry received during the course of this study
13. Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their usual at-home toothbrush and toothpaste between Screening and Visit 1 and between Visit 1 and Visit 2
14. Agree to refrain from using any non-study toothbrushes, dentifrices, mouth rinses, tooth whitening products or floss for the study duration other than their distributed toothbrush and toothpaste between Visit 2 and 3
15. Agree to return for their scheduled visits and to follow all study procedures

Exclusion Criteria

Subjects are excluded from study participation where there is evidence of:
- Any carious lesions requiring restorative treatment;
- Active treatment for periodontitis;
- Fixed orthodontic appliances on the facial surface of their anterior teeth, or have removable denture prosthesis;
- Any disease or conditions that could be expected to interfere with examination procedures or with the subject safely completing the study (including allergies to dyes);
- Using any antibiotics or a chlorhexidine mouth rinse any time within the 2 weeks prior to this visit.

Study & Design

• Study Type: Interventional
• Study Design: Not specified