The main objective of this study is to test which combinations of tooth paste ingredients enhance the feeling of freshness after tooth brushing.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
in-mouth freshness after teeth brushing
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
oral freshness
Secondary outcome
not applicable
Background summary
Regular tooth brushing is of utmost importance for oral health to remove dental
plaque and food from the teeth, assists in suppressing halitosis, and delivers
active ingredients (mainly fluoride) to help prevent tooth and gum disease. The
feeling of oral freshness after tooth brushing is an important driver for
humans to regularly brush their teeth. In this study we test which combinations
of tooth paste ingredients enhance the feeling of freshness after tooth
brushing. In a Randomized Complete Block Design Central Location Test, the
subjects will brush their teeth using a modified toothbrush that allows the
delivery of tooth paste ingredients in-mouth by means of a pumping device
(*gustometer*). Subjects will test a total of 7 different tooth paste
ingredient combinations in a total of 7 sessions with one session per week.
*Freshness* is recorded before tooth brushing and 7 times after tooth brushing
at 10-minutes intervals on a VAS denoted *not fresh at all* and *the freshest
sensation possible* on the extremes. Testing will take place in the morning;
participants are asked to come in without having consumed any food/drink or
participated in any form of oral hygiene since 12:00 am. Participants will
dispense maximum 1.5 g toothpaste product onto the toothbrush, and brush teeth
as they normally would for maximum 45 seconds. While brushing is occurring, the
ingredients to be used as stimuli will be dispensed into the mouth via the
Teflon tubing connected to the toothbrush head. The quantity of ingredients
used as stimuli in the mouth will not exceed the maximum concentrations
commonly found in toothpaste products at any point during the brushing time,
when considering the toothpaste base and any other stimuli being used.
Ingredients used as stimuli will be dispensed into the mouth individually, in
combination or alternation with others. The toothpaste base and stimuli
ingredients will be spit out at the end of the maximum 45 seconds product usage
period. Participants will be asked to complete a questionnaire and/or interview
following the product usage. Each session lasts 1.5h and starts at 8.00am or
8.30am. Subjects receive a free breakfast (bread, butter, jam, cheese, ham,
boiled eggs, milk, coffee, tea, water, all ad libitum) immediately at the end
of each test. They are asked to fill in a food diary the day before each test
to record their food and beverage consumption.
Study objective
The main objective of this study is to test which combinations of tooth paste
ingredients enhance the feeling of freshness after tooth brushing.
Study design
In a Randomized Complete Block Design Central Location Test, the subjects will
brush their teeth using a modified toothbrush that allows the delivery of tooth
paste ingredients in-mouth by means of a pumping device (*gustometer*).
Subjects will test a total of 7 different tooth paste ingredient combinations
in a total of 7 sessions with one session per week. *Freshness* is recorded
before tooth brushing and 7 times after tooth brushing at 10-minutes intervals
on a VAS denoted *not fresh at all* and *the freshest sensation possible* on
the extremes. Testing will take place in the morning at 8:00am or 8:30am;
participants are asked to come in without having consumed any food/drink or
participated in any form of oral hygiene since 12:00 am. Participants will
dispense maximum 1.5 g toothpaste product onto the toothbrush, and brush teeth
as they normally would for maximum 45 seconds. While brushing is occurring, the
ingredients to be used as stimuli will be dispensed into the mouth via the
Teflon tubing connected to the toothbrush head. At the end of each test,
subjects undergo an exit interview and receive a breakfast. Subjects have to
fill in a food diary the day before each test.
Intervention
In a Randomized Complete Block Design Central Location Test, the subjects will
brush their teeth using a modified toothbrush that allows the delivery of tooth
paste ingredients in-mouth by means of a pumping device (*gustometer*).
Subjects will test a total of 7 different tooth paste ingredient combinations
in a total of 7 sessions with one session per week. *Freshness* is recorded
before tooth brushing and 7 times after tooth brushing at 10-minutes intervals
on a VAS denoted *not fresh at all* and *the freshest sensation possible* on
the extremes. Testing will take place in the morning; participants are asked to
come in without having consumed any food/drink or participated in any form of
oral hygiene since 12:00 am. Participants will dispense maximum 1.5 g
toothpaste product onto the toothbrush, and brush teeth as they normally would
for maximum 45 seconds. While brushing is occurring, the ingredients to be used
as stimuli will be dispensed into the mouth via the Teflon tubing connected to
the toothbrush head. The quantity of ingredients used as stimuli in the mouth
will not exceed the maximum concentrations commonly found in toothpaste
products at any point during the brushing time, when considering the toothpaste
base and any other stimuli being used. Ingredients used as stimuli will be
dispensed into the mouth individually, in combination or alternation with
others. The toothpaste base and stimuli ingredients will be spit out at the end
of the maximum 45 seconds product usage period. Participants will be asked to
complete a questionnaire and/or interview following the product usage. Each
session lasts 1.5h and starts at 8.00am or 8.30am. Subjects receive a free
breakfast (bread, butter, jam, cheese, ham, boiled eggs, milk, coffee, tea,
water, all ad libitum) immediately at the end of each test. They are asked to
fill in a food diary the day before each test to record their food and beverage
consumption.
Study burden and risks
The participants have to visit the test location 7 times, once a week during 7
weeks. They arrive in a fasting, non-fresh (non-brushed teeth) state. All
ingredients used are already commonly used in tooth paste products. Except for
increased feelings of freshness no side effects are expected. Besides, no
invasive measurements will be performed. Therefore, the burden for the subjects
is minimal and the risks associated with participation are very low. Fasting
prior to the experiment is required in order to prevent that food intake
affects the freshness scores. Similarly, people are asked not to use any dental
care products prior to the experiment. In order to minimise the discomfort
subject, all session are held in the early hours of the morning and
participants will receive a meal before leaving NIZO food research. The
subjects are paid 175,- upon completion of the study. The incentives are
proportionally to the number of sessions, which the subject attends.
River Road 909
Piscataway 08855-1343
NL
River Road 909
Piscataway 08855-1343
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• age 18-34
• visit the dentist 1 or more times a year for check-up
• use one or more of the following products two or more times a day: toothpaste,
mouthwash, gums, mints, breath spray, breath strips.
• Sign informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• smoker
• taking any medication that may interfere with their sensation of taste, aroma and mouthfeel
• not having full dentures (less than 20 teeth)
• wear braces
• currently experiencing oral irritation or are using oral anaesthetics
• currently participating in oral surgery or extensive dental work
• having allergies to any oral care products or their ingredients
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 | NL44035.081.13 |