Dental PlaquePhase 3NCT00759031
Investigation of Dental Plaque and Gingival Index
A Phase 3 study testing Sodium Monofluorophosphate and Triclosan/Fluoride/Copolymer in people with Dental Plaque, run by Colgate Palmolive at 1 site in United States.
Trial summary
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method. 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?
- Sodium Monofluorophosphate and Triclosan/Fluoride/Copolymer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 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 20 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
- 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
Who cannot join
- Medical condition which requires pre-medication prior to dental visits/procedures
- Advanced periodontal disease
- 5 or more decayed, untreated dental sites
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
- Abnormal salivary function
Show all 13Show fewer
- Use of drugs that can currently 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)
- Pregnant or breastfeeding.
- Participation in another clinical study in the month preceding this study
- Allergic to common dentifrice ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Dental Medicine
New York, New York, 10016
About this study
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
- Conditions
- Dental Plaque
- Being tested
- Sodium Monofluorophosphate, Triclosan/Fluoride/Copolymer
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium MonofluorophosphateDrug
Also called Colgate Great Regular Flavor toothpaste
Brush teeth and evaluate plaque score after one use of the study toothpaste
Triclosan/Fluoride/CopolymerDrug
Also called Colgate Total toothpaste
Brush teeth and evaluate plaque score after one use of the study toothpaste
| Study group | Role | What they receive |
|---|---|---|
| A - Marketed fluoride toothpaste | Placebo comparator | Not described Receives: Drug: Sodium Monofluorophosphate |
| B -Triclosan/NaF/CoPolymer toothpaste | Active comparator | Not described Receives: Drug: Triclosan/Fluoride/Copolymer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Margin Plaque Index
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2008
- Study completionMar 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Corby, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759031
- Sponsor's protocol ID
- CRO-2007-PLA-23-RR
- Status last verified
- Apr 2012
- First submitted
- 23 Sep 2008
- Last updated
- 13 Apr 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 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dental Plaque and Gingival Index
- ClinicalTrials.gov ID
- NCT00759031
- Acronym / sponsor ID
- CRO-2007-PLA-23-RR
- Conditions
- Dental Plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 25 Nov 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Marketed fluoride toothpaste | Placebo comparator | Drug: Sodium Monofluorophosphate |
| B -Triclosan/NaF/CoPolymer toothpaste | Active comparator | Drug: Triclosan/Fluoride/Copolymer |
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 20 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
Key exclusion criteria (13 listed)
- Medical condition which requires pre-medication prior to dental visits/procedures
- Advanced periodontal disease
- 5 or more decayed, untreated dental sites
- Diseases of the soft or hard oral tissues
- Orthodontic appliances
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 |
|---|---|---|
| Sodium MonofluorophosphateAlso: Colgate Great Regular Flavor toothpasteBrush teeth and evaluate plaque score after one use of the study toothpaste | Drug | A - Marketed fluoride toothpaste |
| Triclosan/Fluoride/CopolymerAlso: Colgate Total toothpasteBrush teeth and evaluate plaque score after one use of the study toothpaste | Drug | B -Triclosan/NaF/CoPolymer toothpaste |
Primary outcome
Gingival Margin Plaque Index
Time frame: 1 day
Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
Patricia Corby, 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 Sodium Monofluorophosphate and Triclosan/Fluoride/Copolymer 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 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 13 Apr 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 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 25 Nov 2008). 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?
Gingival Margin Plaque Index (time frame: 1 day). 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 13 Apr 2012.