Dental PlaquePhase 1NCT00762151
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
A Phase 1 study testing Prototype (AN0128 Toothpaste) in people with Dental Plaque, run by Pfizer at 1 site in United States.
Trial summary
The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice. 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?
- Prototype (AN0128 Toothpaste)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2008
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be between ages 18 to 65 years inclusive
- Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
- Must give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hours after initial appointment
- 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 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 14Show fewer
- 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, naproxen), unless approved by the study medical staff
- 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)
- History of allergic reaction to any anti-inflammatory agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Concordia Research Laboratories
Cedar Knolls, New Jersey, 07927
About this study
Official title: Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.
Read the detailed description
The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.
- Conditions
- Dental Plaque
- Being tested
- Negative Control (Regular Toothpaste), Positive Control (anti-plaque/anti-bacterial toothpaste), Prototype (AN0128 Toothpaste)
- Keywords
- Dental Plaque
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Control (Regular Toothpaste)Other
Regular Toothpaste
Positive Control (anti-plaque/anti-bacterial toothpaste)Other
Standard anti-plaque and anti-bacterial toothpaste
Prototype (AN0128 Toothpaste)Drug
AN0128 Toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Negative Control | Placebo comparator | Regular Toothpaste Receives: Other: Negative Control (Regular Toothpaste) |
| Positive Control | Active comparator | Standard anti-plaque and anti-bacterial toothpaste. Receives: Other: Positive Control (anti-plaque/anti-bacterial toothpaste) |
| Prototype | Active comparator | AN0128 Toothpaste Receives: Drug: Prototype (AN0128 Toothpaste) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Measured: Baseline (time zero), 24 hour time point
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 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762151
- Sponsor's protocol ID
- AN0128 Periodontal Plaque
- Status last verified
- Jun 2019
- First submitted
- 24 Sep 2008
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study to Investigate the Anti-Plaque Effect of a Prototype Toothpaste Containing an Anacor Material Via the MGMPI Method
- ClinicalTrials.gov ID
- NCT00762151
- Acronym / sponsor ID
- AN0128 Periodontal Plaque
- Conditions
- Dental Plaque
- Keywords
- Dental Plaque
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- 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.
The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.
Detailed description
The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.
Study design
- Primary purpose
- Prevention
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative Control | Placebo comparator | Other: Negative Control (Regular Toothpaste)Regular Toothpaste |
| Positive Control | Active comparator | Other: Positive Control (anti-plaque/anti-bacterial toothpaste)Standard anti-plaque and anti-bacterial toothpaste. |
| Prototype | Active comparator | Drug: Prototype (AN0128 Toothpaste)AN0128 Toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be between ages 18 to 65 years inclusive
- Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
- Must give written informed consent
- Be in good general health
- Must discontinue oral hygiene for 24-hours after initial appointment
Key exclusion criteria (14 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 |
|---|---|---|
| Negative Control (Regular Toothpaste)Regular Toothpaste | Other | Negative Control |
| Positive Control (anti-plaque/anti-bacterial toothpaste)Standard anti-plaque and anti-bacterial toothpaste | Other | Positive Control |
| Prototype (AN0128 Toothpaste)AN0128 Toothpaste | Drug | Prototype |
Primary outcome
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Time frame: Baseline (time zero), 24 hour time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prototype (AN0128 Toothpaste) in people with Dental Plaque, run by Pfizer 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 14 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 5 Jun 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing) (time frame: Baseline (time zero), 24 hour time point). 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 5 Jun 2019.