Dental PlaquePhase 3NCT00762450
Effect on Bacterial Glycolytic Acid Formation on Plaque
A Phase 3 study testing Triclosan, Fluoride, fluoride and Fluoride, triclosan, amino acid in people with Dental Plaque, run by Colgate Palmolive at 1 site in Switzerland.
Trial summary
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque. Read more about this study
- Who is it for?
- Ages 72 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Triclosan, Fluoride, fluoride and Fluoride, triclosan, amino acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2008to Aug 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 72 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Maxillary dentition is preferentially natural.
- Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
- Natural mandibular front teeth and first premolars (4-4) are retained.
- Second mandibular molars are ideally present to serve as abutment teeth.
- Mandibular restorations and/or reconstructions must be in clinically good condition.
- Partial mandibular denture replacing second premolars and first (and second) molars in good clinical condition.
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- Subjects should have a stimulated saliva flow rate of 1-2 ml/min (by chewing paraffin wax).
- Willingness to give their informed consent and comply with the protocol.
- No history of allergy to personal/oral care consumer products or ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study
Who cannot join
- Current participation in other dental clinical trials.
- Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
- Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
- Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
- Subjects taking drugs known to currently affect salivary flow.
- Subjects with un-stimulated salivary flow <0.3 ml/min and/or stimulated flow <0.9 ml/min.
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- Women who are pregnant or breastfeeding
- History of allergy to common dentifrice ingredients
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
- Women of child bearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (intrauterine device) or condoms)
- Medical condition which requires premedication prior to dental procedures/visits
- History of allergy to amino acids
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich, Dental Institute Dept. of Preventive
Zurich
About this study
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
- Conditions
- Dental Plaque
- Being tested
- Triclosan, Fluoride, fluoride, Fluoride, triclosan, amino acid
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan, FluorideDrug
Also called Total+ Whitening toothpaste
Rinse 3 times daily with assigned toothpaste slurry
fluorideDrug
Also called placebo toothpaste (No triclosan, no amino acid)
Rinse 3 times daily with assigned toothpaste slurry
Fluoride, triclosan, amino acidDrug
Rinse 3 times daily with assigned toothpaste slurry
| Study group | Role | What they receive |
|---|---|---|
| A- Positive Control | Active comparator | fluoride/triclosan/copolymer toothpaste Receives: Drug: Triclosan, Fluoride |
| B - Silica control | Placebo comparator | fluoride only toothpaste Receives: Drug: fluoride |
| C- Experimental product | Experimental | fluoride/triclosan/amino acid toothpaste Receives: Drug: Fluoride, triclosan, amino acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
ph of Dental Plaque After Sucrose Challenge
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Measured: 1 week
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 startApr 2008
- Primary completionAug 2008
- Study completionAug 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Imfeld, MBA, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762450
- Sponsor's protocol ID
- CRO-2008-PLA-01-AM
- Status last verified
- Mar 2012
- First submitted
- 26 Sep 2008
- Last updated
- 7 Mar 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 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on Bacterial Glycolytic Acid Formation on Plaque
- ClinicalTrials.gov ID
- NCT00762450
- Acronym / sponsor ID
- CRO-2008-PLA-01-AM
- Conditions
- Dental Plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 15 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A- Positive Control | Active comparator | Drug: Triclosan, Fluoridefluoride/triclosan/copolymer toothpaste |
| B - Silica control | Placebo comparator | Drug: fluoridefluoride only toothpaste |
| C- Experimental product | Experimental | Drug: Fluoride, triclosan, amino acidfluoride/triclosan/amino acid toothpaste |
Who may qualify
- Ages
- 72 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Maxillary dentition is preferentially natural.
- Maxillary restorations and/or reconstructions and eventual partial dentures must be in clinically good condition.
- Natural mandibular front teeth and first premolars (4-4) are retained.
- Second mandibular molars are ideally present to serve as abutment teeth.
- Mandibular restorations and/or reconstructions must be in clinically good condition.
Key exclusion criteria (12 listed)
- Current participation in other dental clinical trials.
- Subjects who are unable to provide sufficient plaque growth over a 2-day non- brushing period (by visual assessment).
- Subjects in whom the plaque pH fails to fall sufficiently, i.e. at least to pH 5 following a sucrose rinse.
- Subjects with poor oral health, i.e. with advanced periodontitis, un-restored carious lesions and stomatological diseases.
- Subjects taking drugs known to currently affect salivary flow.
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 |
|---|---|---|
| Triclosan, FluorideAlso: Total+ Whitening toothpasteRinse 3 times daily with assigned toothpaste slurry | Drug | A- Positive Control |
| fluorideAlso: placebo toothpaste (No triclosan, no amino acid)Rinse 3 times daily with assigned toothpaste slurry | Drug | B - Silica control |
| Fluoride, triclosan, amino acidRinse 3 times daily with assigned toothpaste slurry | Drug | C- Experimental product |
Primary outcome
ph of Dental Plaque After Sucrose Challenge
Time frame: 1 week
Panelists rinsed with toothpaste slurry (2 grams of toothpaste dissolved in 10 ml of water) waited 20 minutes and then rinsed with a 10% sucrose solution. Sucrose challenge is used to change the ph in the mouth and help determine if the toothpastes used in this study and control dental plaque growth.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Thomas Imfeld, MBA 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, Fluoride, fluoride and Fluoride, triclosan, amino acid in people with Dental Plaque, run by Colgate Palmolive at 1 site in Switzerland.
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 9 inclusion and 12 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 Mar 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 Switzerland. 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 15 Feb 2011). 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?
ph of Dental Plaque After Sucrose Challenge (time frame: 1 week). 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 Mar 2012.