A clinical study to compare the dental plaque removal efficacy of a new electric toothbrush compared to a regular manual toothbrush

Not Applicable

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

• Registration Number: ISRCTN28649560
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-21
• Last Update Posted: 31 August 2020
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Be at least 18 years of age
2. Provide written informed consent prior to participation and be given a signed copy of the informed consent form
3. Be in general good health as determined by the Investigator/designee based on a review/update of their medical history
4. Have sufficient amount of plaque (estimated 10% coverage on buccal sites of front teeth after 24 hours build-up as estimated by DPIA operator)
5. Possess a minimum of 10 natural anterior teeth with facial scorable surfaces (Not including teeth with crowns, excessive facial restorations or severe staining from tetracycline, fluorosis or hypocalcification)
6. Agree not to participate in any other oral care study for the duration of this study
7. Agree to return for scheduled visits and follow the study procedures
8. Agree to refrain from use of any non-study oral hygiene products (including prescription rinses) for the duration of the study
9. Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study and to report any non-study dentistry received during the course of this study
10. Agree to refrain from using dental floss during the treatment periods of this study (Tuesday through Tuesday)
11. Agree to refrain from all oral hygiene procedures for approximately 24 hours prior to all subsequent morning visits
12. Agree to refrain from all oral hygiene procedures between all subsequent morning on-site brushings and the afternoon imaging visits
13. Agree to refrain from eating, drinking*, chewing gum and using tobacco for 2 hours prior to their morning appointments and 1 hour prior to their afternoon appointments? *The only exception being allowed small sips of water up until 1 hour prior to their morning appointments

Exclusion Criteria

1. Hypersensitivity to dyes
2. Any caries lesions requiring restorative treatment
3. Active treatment for periodontitis
4. Fixed facial or lingual orthodontic appliances
5. Self-reported pregnancy or lactation
6. Performing any oral hygiene the morning of or the evening prior to their Visit 1 study visit
7. Having eaten, drank, used tobacco or chewed gum for at least 2 hours prior to their Baseline visit (Small sips of water will be allowed up to 45 minutes prior to the visit)
8. Any diseases or condition that could be expected to interfere with examination procedures or with the subject safely competing the study (including allergies to dyes)
9. Inability to undergo study procedures
10. Using an antibiotic or a chlorhexidine mouth rinse any time within 2 weeks prior to this visit
11. Calculus on the facial surface of their teeth (per operator discretion)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in afternoon plaque (5 hours post-brushing) measured by DPIA score (digital plaque imaging analysis) across the 8 days of treatment

Secondary Outcome Measures

Name	Time	Method
Morning pre-brushing plaque coverage measured by DPIA score (digital plaque imaging analysis) analysed separately for days 3 and 8 to determine treatment differences