Salivary Bacteria LevelsPhase 3NCT00981825
Efficacy of Salivary Bacteria and Post Brushing
A Phase 3 study testing Fluoride and Triclosan/Fluoride in people with Salivary Bacteria Levels, run by Colgate Palmolive at 1 site in India.
Trial summary
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Salivary Bacteria Levels
- What is being tested?
- Fluoride and Triclosan/Fluoride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2007to Dec 2007
- 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 volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- No 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 eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
- 2 or more decayed untreated dental sites at screening.
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- Other disease of the hard or soft oral tissues.
- Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
- Use of medications that can currently affect salivary flow
- Current use of antibiotics
- Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
- Pregnant or nursing women.
- Participation in any other clinical study within 30 days prior to enrollment into this study.
- Use of tobacco products
- Subjects who must receive dental treatment during the study dates.
- Current use of Antibiotics for any purpose.
- Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
- Conditions
- Salivary Bacteria Levels
- Being tested
- Fluoride, Triclosan/Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorideDrug
Also called fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
Whole mouth brushing for 7 days
Triclosan/FluorideDrug
Also called triclosan/fluoride toothpaste (Colgate Total toothpaste)
Brush whole mouth twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | fluoride toothpaste control Receives: Drug: Fluoride |
| B | Active comparator | triclosan/fluoride toothpaste Receives: Drug: Triclosan/Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
CFU (Colony Forming Units)
Total number of salivary bacterial colony forming units (lower number = less colonies present)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
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 Salivary Bacteria LevelsStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Neelim Utgikar, DDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981825
- Sponsor's protocol ID
- ER0-2007-SAL-01-GX
- Status last verified
- Jun 2011
- First submitted
- 26 Sep 2008
- Last updated
- 14 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Salivary Bacteria and Post Brushing
- ClinicalTrials.gov ID
- NCT00981825
- Acronym / sponsor ID
- ER0-2007-SAL-01-GX
- Conditions
- Salivary Bacteria Levels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 22 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Fluoridefluoride toothpaste control |
| B | Active comparator | Drug: Triclosan/Fluoridetriclosan/fluoride 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 volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- No 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 (17 listed)
- Medical condition which requires pre-medication prior to dental procedures/visits
- Medical condition which precludes eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
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 |
|---|---|---|
| FluorideAlso: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)Whole mouth brushing for 7 days | Drug | A |
| Triclosan/FluorideAlso: triclosan/fluoride toothpaste (Colgate Total toothpaste)Brush whole mouth twice daily for 7 days | Drug | B |
Primary outcome
CFU (Colony Forming Units)
Time frame: 4 hours
Total number of salivary bacterial colony forming units (lower number = less colonies present)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Neelim Utgikar, 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 Triclosan/Fluoride in people with Salivary Bacteria Levels, run by Colgate Palmolive at 1 site in India.
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 17 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 14 Jun 2011. 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 India. 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 22 Sep 2009). 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?
CFU (Colony Forming Units) (time frame: 4 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 14 Jun 2011.