A randomized clinical study to compare the efficacy of a new interactive toothbrush in the prevention of dental stai

Not Applicable

Completed

• Conditions: Dental stain on facial surfaces of the anterior teeth; Oral Health

• Registration Number: ISRCTN80868903
• Lead Sponsor: Procter & Gamble (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-04
• Study Completion: 2021-10-07
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Be at least 18 years of age and typically use a manual toothbrush
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 a minimum of 10 anterior teeth suitable for grading (i.e., no crowns, bridge abutments, composites or porcelain veneers, large composite restorations or anterior calculus) with visible surface stain on the facial surfaces
5. Agree not to participate in any other oral care study for the duration of this study
6. Agree to return for scheduled visits and follow the study procedures
7. Agree to refrain from the use of any non-study oral hygiene products (including prescription rinses) for the duration of the study
8. 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

Exclusion Criteria

1. Generalized gingival recession
2. Generalized malocclusion or overlapping of teeth
3. Inability to comply with brushing instructions (e.g. dexterity or comprehension issues)
4. Obvious periodontal disease, as evidenced by purulent exudate, tooth mobility, or any condition that could potentially compromise the integrity of the data
5. Fixed orthodontic appliances on the facial surfaces of their anterior teeth
6. Self-reported pregnancy or lactation
7. Severe or atypical intrinsic staining, such as that caused by tetracycline, fluorosis, or hypo-calcification on the facial surface of their anterior teeth
8. Carious lesions on the facial surface of their anterior teeth
9. Had a dental prophylaxis within the previous 2 months
10. Have any condition or disease, as determined by the Investigator/Designee, which could be expected to interfere with study procedures or with the subject’s safe completion of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified