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van CCT (UK)

van CCT (UK)

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

- candidate number25247
- NTR NumberNTR6081
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-sep-2016
- Secondary IDsNL58265.018.16 METC 2016_175
- Public TitleInterdental brush and waterflosser on gingival bleeding and gingival abrasions. A 4 weeks randomized clinical trial.
- Scientific TitleThe effect of an interdental brush and a water flosser on gingival bleeding and gingival abrasions. A 4 weeks randomized clinical trial.
- hypothesisTo assess the effect of the commercially available Water Flosser compared to interdental brushes evaluating gingival bleeding and gingival abrasions in a group of systemically healthy participants with gingivitis but without periodontitis.
- Healt Condition(s) or Problem(s) studiedGingivitis, Gingival abrasion
- 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- 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
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-sep-2016
- planned closingdate10-nov-2016
- Target number of participants80
- InterventionsTest 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 of a regular toothpaste
- Primary outcomeBleeding upon Pocket probing (BOPP)
- Secondary outcome- 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
- TimepointsScreening
Visit 1: baseline
Visit 2: week 2
Visit 3: week 4
- Trial web site
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator ACTA-ADR
- Funding
(Source(s) of Monetary or Material Support)
Water Pik Technologies, Inc.
- PublicationsN/A
- Brief summaryThe toothbrush does not adequately reach the interproximal surfaces of the teeth. As gingivitis and periodontitis are usually more pronounced in the interdental areas than on the oral or facial surfaces in susceptible patients. The rationale is to determine the effectiveness of product Water Flosser with water and interdental brush on gingival bleeding and gingival abrasion and to evaluate subjects’ attitudes towards the used products in this study.
- Main changes (audit trail)
- RECORD1-sep-2016 - 11-nov-2016

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