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The effect of Philips Airfloss Ultra plus Listerine compared to dental floss on gingival bleeding, dental plaque, and gingival abrasion in a healing of experimental gingivitis model, a parallel design

The effect of Philips Airfloss Ultra plus Listerine compared to dental floss on gingival bleeding, dental plaque, and gingival abrasion in a healing of experimental gingivitis model, a parallel design - APPLE: Airfloss Ultra plus Listerine Evaluated

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42140
Enrollment
80
Registered
2015-01-22
Start date
2015-02-03
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Gingivitis bleeding gums Inflammation of the gums

Interventions

Philips Airfloss Ultra plus Listerine Cool Mint

Sponsors

ACTA Dental Research B.V. (ADR)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male and female - Right handed brusher and writer - Age 18-35 years - Classified as systemically healthy, assessed by medical questionnaire - Minimum of 20 natural teeth: at least 5 evaluable in each quadrant of the lower jaw available - DPSI 0-3 minus - a screening for bleeding on marginal probing *25% - Dental floss should fit interdentally in at least three interdental spaces per quadrant in the lower jaw, excluding the interdental central incisors space. Of these three spaces, at least two spaces should involve of the molar area. - Willing and able to give written informed consent - Agree to follow the study instructions for the duration of the study - Agree to refrain from brushing the lower jaw for 21 days in the experimental phase

Exclusion criteria

Exclusion criteria: - Overt dental caries - Usage of any interdental device as part of regular daily oral care (>1 time a week) - Smokers (Lie et al. 1998, definition non-smoker:

Design outcomes

Primary

MeasureTime frame
The main study parameter is the level of Bleeding On Marginal Probing (BOMP) (Van der Weijden et al. 1994).

Secondary

MeasureTime frame
The secundary outcome is (clinical): - Level of gingival abrasion ; Gingival Abrasion Score (Van der Weijden et al. 2004). - Subjects* attitude towards the study products The secundary outcome is (laboratory): * Microbial ecology of interdental plaque * Microbial ecology of tongue dorsum * Total Candida counts in unstimulated saliva, interdental plaque and tongue dorsum * Total bacterial counts in saliva, interdental plaque and tongue dorsum?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)