Dental PlaquePhase 3NCT01024738
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
A Phase 3 study testing Fluoride, Triclosan, fluoride and Chlorhexidine Gluconate in people with Dental Plaque, run by Colgate Palmolive at 1 site in United States.
Trial summary
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Fluoride, Triclosan, fluoride and Chlorhexidine Gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged 18 to 65 years inclusive
- Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
- If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
Who cannot join
- Medical condition which requires pre-medication (antibiotics) prior to dental
- Visits/procedures
- Allergy to chlorhexidine
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
- Diseases of the soft or hard oral tissues (gums or palate)
Show all 15Show fewer
- Orthodontic appliances that interfere with plaque rating
- Abnormal salivary function
- Use of drugs that can affect currently salivary flow or production
- Use of antibiotics one (1) month prior to or during this study
- Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen,naproxyn)
- Pregnant or breastfeeding.
- Participation in another research study in the month preceding this study
- Allergic to common toothpaste or mouth rinse ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Trial locations and contacts
1 site in 1 country.
About this study
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Read the detailed description
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
- Conditions
- Dental Plaque
- Being tested
- Fluoride, Triclosan, fluoride, Chlorhexidine Gluconate
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Brush half mouth twice daily for four days.
Triclosan, fluorideDrug
Also called Total toothpaste
Brush twice daily
Chlorhexidine GluconateDrug
Rinse mouth twice a day
| Study group | Role | What they receive |
|---|---|---|
| Fluoride toothpaste | Placebo comparator | negative control toothpaste Receives: Drug: Fluoride |
| Triclosan/Fluoride toothpaste | Active comparator | positive control toothpaste (Total toothpaste) Receives: Drug: Triclosan, fluoride |
| Chlorhexidine Oral Rinse | Active comparator | positive control oral rinse Receives: Drug: Chlorhexidine Gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Measured: 4 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark LeFelt, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024738
- Sponsor's protocol ID
- CRO-2008-PLA-05-RR
- Status last verified
- Oct 2009
- First submitted
- 26 Sep 2008
- Last updated
- 3 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
- ClinicalTrials.gov ID
- NCT01024738
- Acronym / sponsor ID
- CRO-2008-PLA-05-RR
- Conditions
- Dental Plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Posted 3 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Detailed description
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride toothpaste | Placebo comparator | Drug: Fluoridenegative control toothpaste |
| Triclosan/Fluoride toothpaste | Active comparator | Drug: Triclosan, fluoridepositive control toothpaste (Total toothpaste) |
| Chlorhexidine Oral Rinse | Active comparator | Drug: Chlorhexidine Gluconatepositive control oral rinse |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be aged 18 to 65 years inclusive
- Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study
Key exclusion criteria (15 listed)
- Medical condition which requires pre-medication (antibiotics) prior to dental
- Visits/procedures
- Allergy to chlorhexidine
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
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 |
|---|---|---|
| FluorideBrush half mouth twice daily for four days. | Drug | Fluoride toothpaste |
| Triclosan, fluorideAlso: Total toothpasteBrush twice daily | Drug | Triclosan/Fluoride toothpaste |
| Chlorhexidine GluconateRinse mouth twice a day | Drug | Chlorhexidine Oral Rinse |
Primary outcome
Plaque Index
Time frame: 4 Days
Plaque score is Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
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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.
Mark LeFelt, DDS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride, Triclosan, fluoride and Chlorhexidine Gluconate in people with Dental Plaque, run by Colgate Palmolive 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 6 inclusion and 15 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 3 Dec 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plaque Index (time frame: 4 Days). 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 3 Dec 2009.