A study to evaluate the plaque removal efficacy of a new manual toothbrush

Not Applicable

Completed

• Conditions: General healthy adults with evidence of overnight dental plaque; Oral Health

• Registration Number: ISRCTN44194796
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-03
• Study Completion: 2020-10-16
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Give written informed consent and receive a copy of the signed 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. Have been previously qualified to participate in a plaque panel
5. Possess a minimum of 16 scorable teeth (excluding third molars) with facial and lingual scorable surfaces
6. Abstained from all oral hygiene procedures for approximately 24 hours prior to this visit and agree to follow this same restriction prior to all visits
7. Abstained from eating, drinking*, chewing gum and using tobacco for at least 4 hours prior to this visit and agree to follow these same restrictions prior to all visits. *Allowed small sips of water up until 45 minutes prior to their appointment
8. Agree not to participate in any other oral care study for the duration of this study
9. Agree to delay any elective dentistry, including dental prophylaxis, and to report any non-study dentistry received during the course of this study
10. 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 used between visits
11. Agree to maintain their same usual at-home toothbrush and toothpaste for the study duration
12. Agree to return for their scheduled visits and to follow all study procedures

Exclusion Criteria

1. Five or more carious lesions requiring restorative treatment
2. Active treatment for periodontitis
3. Active orthodontic therapy, or removable denture prosthesis
4. Any disease or condition that could be expected to interfere with examination procedures or with the subject’s safe completion of this study (including allergies to dyes)
5. 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

Primary Outcome Measures

Name	Time	Method
Dental plaque (pre- and post-brushing) measured using the Turesky Modified Quigley-Hein Plaque Index (TQHPI) at each visit (Day 1, Day 3, Day 5, and Day 7)

Secondary Outcome Measures

Name	Time	Method
<br> Current secondary outcome measures as of 16/10/2020:<br> There are no secondary outcome measures<br><br> Previous secondary outcome measures:<br> Dental plaque measured using a new exploratory plaque index at each visit (Day 1, Day 3, Day 5, and Day 7, pre- and post-brushing) in the age group of 7-9-year-old children<br>