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Interdental brush and waterflosser on gingival bleeding and gingival abrasions. A 4 weeks randomized clinical trial.

The effect of an interdental brush and a water flosser on gingival bleeding and gingival abrasions. A 4 weeks randomized clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24237
Enrollment
80
Registered
2016-09-01
Start date
2016-09-13
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 Gingival abrasion

Interventions

Test groep: Waterpik® with a classic standard jet tip (with water) + manual toothbrush with the use of a regular toothpaste Control groep: Interdental brush Interprox+ manual toothbrush with the use

Sponsors

ACTA-ADR B.V.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Male and female - Age 18-65 years - Right handed brusher and writer - Classified as systemically healthy - Non-smokers (Lie et al. 1998) definition non-smoker: <1 cigarette every day for at least one year -Moderate gingivitis (level of gingival bleeding assessed BOPP ; 50%) - Minimum of 20 natural teeth, at least 5 evaluable in each quadrant available - Buccal accessible interdental spaces to apply the interdental brush -The interdental brushes must fit between at least 4 spaces per quadrant when approached buccally, of these 2 should be interdental spaces involving at least two spaces of the molar area. - The other 2 spaces can be between the pre-molars, cuspid and incisors. The participant is willing during the study: - able to give written informed consent - to brush with a manual toothbrush for the duration of the study.

Exclusion criteria

Exclusion criteria: - Pockets deeper than 5mm (excluding distal of the last molars) - Overt dental caries - Oral lesions - Usage of any interdental device as part of regular daily oral care - Removable (partial) dentures - Crowns, bridges and implant supported restorations - Removable night guard - Orthodontic banding (except for lingual retention wire) - Oral and/or peri-oral piercings - Dental student or dental professional - Participation in a clinical study within the previous 30 days General health: - Medication, except for birth control pills - Self-reported pregnancy or breastfeeding - Use of antibiotics during the last 3 months - Need of antibiotic prophylaxis prior to dental treatment - Use of anti-inflammatory drugs on a regular basis

Design outcomes

Primary

MeasureTime frame
Bleeding upon Pocket probing (BOPP)

Secondary

MeasureTime frame
- Bleeding On Marginal Probing (BOMP) - Modfied gingival abrasion index - Subjects'attidue towards the study protocol and study products according to a questionnaire - Clinical photos taken of the buccal aspect of teeth from cuspid to cuspid

Contacts

Public ContactG.A. Weijden, van der

Acedemisch Centrum Tandheelkunde Amsterdam (ACTA) Afdeling CPT- Parodontologie Gustav Mahlerlaan 3004

ga.vd.weijden@acta.nl+31 (0)20 5188307

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)