Dental PlaquePhase 3NCT00762853
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
A Phase 3 study testing Fluoride and Fluoride and triclosan in people with Dental Plaque, run by Colgate Palmolive at 1 site in Thailand.
Trial summary
The objective is to develop a method to determine active ingredient uptake in oral care products. 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 and Fluoride and triclosan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- May 2008to Jun 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
- Male or female volunteer 18 - 65 years of age (inclusive).
- Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
- Able and willing to sign the informed consent form.
- Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Who cannot join
- Medical condition which requires pre-medication prior to dental procedures/visits
- Medical condition which precludes not eating/drinking for 2 hours
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
Show all 13Show fewer
- Abnormal salivary function
- Use of drugs that can affect salivary flow
- 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, etc)
- Pregnant or breastfeeding.
- Participation in another clinical study in the month preceding this study
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
About this study
The objective is to develop a method to determine active ingredient uptake in oral care products.
- Conditions
- Dental Plaque
- Being tested
- Fluoride, Fluoride and triclosan
- 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 once with assigned study treatment
Fluoride and triclosanDrug
Also called Colgate Total toothpaste
Brush half mouth once with assigned study treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | fluoride toothpaste from Thailand Receives: Drug: Fluoride |
| B | Active comparator | fluoride/triclosan/copolymer toothpaste Receives: Drug: Fluoride and triclosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triclosan Concentration in Dental Plaque
Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2008
- Study completionJun 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Terdphong Triantana, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762853
- Sponsor's protocol ID
- CRO-2008-PLA-16-RR
- Status last verified
- Aug 2010
- First submitted
- 26 Sep 2008
- Last updated
- 17 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Method to Triclosan Retention in Plaque Following Brushing
- ClinicalTrials.gov ID
- NCT00762853
- Acronym / sponsor ID
- CRO-2008-PLA-16-RR
- Conditions
- Dental Plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 14 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to develop a method to determine active ingredient uptake in oral care products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Fluoridefluoride toothpaste from Thailand |
| B | Active comparator | Drug: Fluoride and triclosanfluoride/triclosan/copolymer toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female volunteer 18 - 65 years of age (inclusive).
- Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
- Able and willing to sign the informed consent form.
- Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
- No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Key exclusion criteria (13 listed)
- Medical condition which requires pre-medication prior to dental procedures/visits
- Medical condition which precludes not eating/drinking for 2 hours
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
- Diseases of the soft or hard oral tissues
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 once with assigned study treatment | Drug | A |
| Fluoride and triclosanAlso: Colgate Total toothpasteBrush half mouth once with assigned study treatment | Drug | B |
Primary outcome
Triclosan Concentration in Dental Plaque
Time frame: 12 hours
Triclosan is analyzed by gas chromatography (GC) with Atomic Emission Detection (480 nm) and quantitated by determining the ration of the peak height of triclosan to the peak height of an internal standard and relating the result to corresponding ratios of calibration standards.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Terdphong Triantana, 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 and Fluoride and triclosan in people with Dental Plaque, run by Colgate Palmolive at 1 site in Thailand.
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 5 inclusion and 13 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 17 Feb 2012. 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 Thailand. 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 14 Sep 2010). 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?
Triclosan Concentration in Dental Plaque (time frame: 12 hours). 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 17 Feb 2012.