The present study aims at testing the adjunctive effect to toothbrushing of the Waterpik® dental water jet (DWJ) with a new jet tip in the potential to remove plaque biofilm and improve gingival health as compared to the Waterpik® dental water jet…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gingivitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quigley & Hein plaque index (QHI)
Bleeding on marginal probing index (BOMP)
Secondary outcome
VAS-questionnaire
Background summary
As gingivitis and periodontitis are usually more pronounced in the interdental
areas than on the oral or facial surfaces in susceptible patients, the removal
of plaque from these surfaces is very important.Therefore various adjuncts to
plaque control have been developed such as dental floss, toothpicks and
interdental brushes. However, daily interproximal plaque control is not a
regular behavior. A common problem with all interdental cleaning aids is
patient dexterity and motivation. Additional oral hygiene aids have been
developed in an attempt to augment the effect of toothbrushing on reducing
interdental plaque. A dental water jet or oral irrigator is an electric device
which aims at the removal of plaque, both interdentally and along the gumline,
to increase the performance of the oral hygiene and thus to improve the
gingival health.
Study objective
The present study aims at testing the adjunctive effect to toothbrushing of the
Waterpik® dental water jet (DWJ) with a new jet tip in the potential to remove
plaque biofilm and improve gingival health as compared to the Waterpik® dental
water jet with a regular jet tip, and to the use of dental floss.
Study design
The study is randomized, single blind, 3-group parallel, 30 day home use model
combined with the use of a regular flat trimmed manual toothbrush (ADA)
together with a standard dentifrice. Subjects will be randomly assigned to one
of 3 groups according to a randomization list. During the 30-day experimental
phase subjects in the test group will use the Waterpik® dental water jet with a
new jet tip (test product) once a day in the evening. Subjects in the control
group will use the Waterpik® dental water jet (DWJ) with a standard jet tip
once a day in the evening. Subjects in the negative control group will use
standard waxed dental floss once a day in the evening. To check for compliance,
subjects are asked to register the time of use of the products onto a calendar
record chart.
After meeting the inclusion criteria and completing informed consent subjects
will be assessed for the first time (S1) for their baseline data for both
indices. First gingivitis and secondly plaque according to the above described
procedures. Subsequently each subject will receive a demonstration and verbal
instruction from the study coordinator immediately following the screening
assessment. At this moment subjects will use their allocated product for the
first time. At 14 days (S2), subjects return to the clinic for the clinical
assessments for both gingivitis and plaque. At 30 days (S3), again subjects
return to the clinic for their final assessment for both parameters. Finally,
after the last assessment, all subjects will receive a questionnaire using a
visual analogue scale (VAS) designed to evaluate their attitudes with regard to
the product used.
Intervention
- One group will use: Waterpik® DWJ with a new jet tip + ADA toothbrush /
regular toothpaste (test).
- Another group will use: Waterpik® DWJ with a standard jet tip + ADA
toothbrush / regular toothpaste (control).
- A third group will use standard waxed floss + ADA toothbrush / regular
toothpaste (control).
Study burden and risks
No
Louwesweg 1
1066 EA AMSTERDAM
Nederland
Louwesweg 1
1066 EA AMSTERDAM
Nederland
Listed location countries
Age
Inclusion criteria
-*18 years of age, -a minimum of 5 evaluable teeth in each quadrant (with no partial dentures, orthodontic banding or wires) * 50% bleeding on marginal probing.
Exclusion criteria
oral lesions and/or periodontal pockets >5 mm - pregnancy or systemic diseases such as diabetes
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28943.018.09 |