Healthy IndividualsNCT02409836
A Study to Assess the Ingestion of Dentifrice by Children
A study testing Marketed Dentifrice and Marketed Flavored Dentifrice in people with Healthy Individuals, run by Procter and Gamble at 1 site in United States.
Trial summary
The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Marketed Dentifrice and Marketed Flavored Dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 1993to Jul 1993
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be between the ages of 2 and 12, inclusive
- Be healthy, with no illness that, in the judgment of the investigator or examining dentist, would interfere with the conduct of the test
- Be currently, and have been for at least three months immediately prior to the start of the study, brushing (or being brushed by care giver) their teeth on a daily basis
- Have parent/guardian complete and return the consent form
Who cannot join
- Have diabetes
- Be on dialysis
- Have an oral health condition that, in judgment of investigator or study medical personnel, could interfere with the conduct of the study.
- Wear metal braces
- Have an incomplete or missing consent form
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.
- Conditions
- Healthy Individuals
- Being tested
- Marketed Dentifrice, Marketed Flavored Dentifrice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed DentifriceDrug
Marketed Dentifrice
Marketed Flavored DentifriceDrug
Hawaiian Punch Flavored
Marketed Flavored DentifriceDrug
Bubble Gum Flavored
| Study group | Role | What they receive |
|---|---|---|
| Crest Cavity Protection | Active comparator | Marketed Dentifrice Receives: Drug: Marketed Dentifrice |
| Crest for Kids Hawaiian Punch Paste | Active comparator | Marketed Dentifrice Receives: Drug: Marketed Flavored Dentifrice |
| Crest for Kids Bubble Gum Paste | Active comparator | Marketed Dentifrice Receives: Drug: Marketed Flavored Dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of dentifrice ingested and used by various age groups of children.
Measured: 10 weeks
Secondary outcomes (1)
Dentifrice ingestion amount as a function of dentifrice flavor and age of participants.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMay 1993
- Primary completionJul 1993
- Study completionJul 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John E Wild, Principal investigator, HIlltop Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409836
- Sponsor's protocol ID
- 000393
- Status last verified
- Apr 2015
- First submitted
- 24 Mar 2015
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Ingestion of Dentifrice by Children
- ClinicalTrials.gov ID
- NCT02409836
- Acronym / sponsor ID
- 000393
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- May 1993
- Primary completion
- Jul 1993 (actual)
- Study completion
- Jul 1993 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crest Cavity Protection | Active comparator | Drug: Marketed DentifriceMarketed Dentifrice |
| Crest for Kids Hawaiian Punch Paste | Active comparator | Drug: Marketed Flavored DentifriceMarketed Dentifrice |
| Crest for Kids Bubble Gum Paste | Active comparator | Drug: Marketed Flavored DentifriceMarketed Dentifrice |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Be between the ages of 2 and 12, inclusive
- Be healthy, with no illness that, in the judgment of the investigator or examining dentist, would interfere with the conduct of the test
- Be currently, and have been for at least three months immediately prior to the start of the study, brushing (or being brushed by care giver) their teeth on a daily basis
- Have parent/guardian complete and return the consent form
Key exclusion criteria (5 listed)
- Have diabetes
- Be on dialysis
- Have an oral health condition that, in judgment of investigator or study medical personnel, could interfere with the conduct of the study.
- Wear metal braces
- Have an incomplete or missing consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marketed DentifriceMarketed Dentifrice | Drug | Crest Cavity Protection |
| Marketed Flavored DentifriceHawaiian Punch Flavored | Drug | Crest for Kids Hawaiian Punch Paste |
| Marketed Flavored DentifriceBubble Gum Flavored | Drug | Crest for Kids Bubble Gum Paste |
Primary outcome
Level of dentifrice ingested and used by various age groups of children.
Time frame: 10 weeks
1 secondary outcome
Dentifrice ingestion amount as a function of dentifrice flavor and age of participants.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John E Wild principal investigator
HIlltop Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed Dentifrice and Marketed Flavored Dentifrice in people with Healthy Individuals, run by Procter and Gamble at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of dentifrice ingested and used by various age groups of children. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.