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

A clinical study to compare the stain prevention potential of a new power brush with a whitening brush head compared to a manual control toothbrush

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80868903
Enrollment
100
Registered
2021-05-04
Start date
2021-06-28
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental stain on facial surfaces of the anterior teeth Oral Health

Interventions

Participants are stratified at baseline on average modified Lobene composite score of the facial and lingual surfaces, smoking, the consumption of coffee/tea and age. Within these strata, participants

Sponsors

Procter & Gamble (United States)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Intensity and extent of extrinsic dental stain on the facial and lingual surfaces of the anterior teeth is measured using Composite Modified Lobene Stain Index at Week 4 and Week 12 2. Intensity and extent of extrinsic dental stain in four different regions (gingival, body, mesial and distal) on the facial surfaces of the anterior teeth is measured using Interproximal Modified Lobene Index at Weeks 4 and 12

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026