Periodontal DiseasesPhase 3NCT00763165
Periodontal Disease and Cardiovascular Disease
A Phase 3 study testing Triclosan and Fluoride in people with Periodontal Diseases, run by Colgate Palmolive at 1 site in Australia.
Trial summary
To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Triclosan and Fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2000to Dec 2009
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A minimum of 12 uncrowned teeth other than 3rd molars
- Age 18 to 75 years
- Informed consent
Who cannot join
- Prosthetic heart valves
- Prosthetic joint replacement
- Previous infective endocarditis
- Requirement for antibiotic cover for dental treatment
- Current treatment with warfarin
Trial locations and contacts
1 site in 1 country.
About this study
To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.
- Conditions
- Periodontal Diseases
- Being tested
- Triclosan, Fluoride
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriclosanDrug
Brush twice daily
FluorideDrug
Brush twice daily
FluorideDrug
Brush twice daily
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Triclosan; Drug: Fluoride |
| B | Placebo comparator | Not described Receives: Drug: Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal disease
Measured: 3-5 Years
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 startNov 2000
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregory Seymour, BDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763165
- Sponsor's protocol ID
- D/06/Dent/99
- Status last verified
- Sep 2008
- First submitted
- 26 Sep 2008
- Last updated
- 2 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00763165
- Acronym / sponsor ID
- D/06/Dent/99
- Conditions
- Periodontal Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Nov 2000
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 30 Sep 2008 (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.
To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Triclosan, Drug: Fluoride |
| B | Placebo comparator | Drug: Fluoride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A minimum of 12 uncrowned teeth other than 3rd molars
- Age 18 to 75 years
- Informed consent
Key exclusion criteria (5 listed)
- Prosthetic heart valves
- Prosthetic joint replacement
- Previous infective endocarditis
- Requirement for antibiotic cover for dental treatment
- Current treatment with warfarin
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 |
|---|---|---|
| TriclosanBrush twice daily | Drug | A |
| FluorideBrush twice daily | Drug | A |
| FluorideBrush twice daily | Drug | B |
Primary outcome
Periodontal disease
Time frame: 3-5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2008.
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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.
Gregory Seymour, BDS 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 Triclosan and Fluoride in people with Periodontal Diseases, run by Colgate Palmolive at 1 site in Australia.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2008. 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 Australia. 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?
Results are not available in the source record.
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?
Periodontal disease (time frame: 3-5 Years). 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 2 Oct 2008.