Oral Bacteria Levels in the MouthPhase 4NCT02194621
Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
A Phase 4 study testing Total Flavor option 1 and Total Flavor option 2 in people with Oral Bacteria Levels in the Mouth, run by Colgate Palmolive at 1 site in United States.
Trial summary
The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. Read more about this study
- Who is it for?
- Ages 22 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Bacteria Levels in the Mouth
- What is being tested?
- Total Flavor option 1 and Total Flavor option 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2014
- Phase
- Phase 4
- 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 22 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females in good general health aged 18 to 70 years.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- Adequate oral hygiene and no signs of oral neglect.
- Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm.
- Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.
Who cannot join
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
- Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
- History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
- Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).
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- History of active severe periodontal disease with bleeding gums and loose teeth.
- Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count.
- Fixed or removable orthodontic appliance or removable partial dentures.
- Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.
- Self reported pregnancy or lactation.
- History or current use of objects to pierce the lips or tongue.
- Subjects known to be an alcoholic, or a recovering alcoholic.
- History or current use of recreational drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07107
About this study
Official title: A Randomized, Single Center, Three Cell, Double Blind and Parallel Groups Clinical Study Conducted in Newark, NJ to Evaluate the Antibacterial Effects of Two Toothpastes Containing 0.3% Triclosan/2% Copolymer/0.243% Sodium Fluoride in a Silica Base as Compared to a Control Regular Fluoride Toothpaste on Oral Bacteria 12 Hours After 13 Days Product Use.
The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.
- Conditions
- Oral Bacteria Levels in the Mouth
- Being tested
- Total Flavor option 1, Total Flavor option 2, Placebo toothpaste: Crest Cavity Protection toothpaste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Flavor option 1Drug
Also called Total toothpaste
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
Total Flavor option 2Drug
Also called Total toothpaste
Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
Placebo toothpaste: Crest Cavity Protection toothpasteDrug
Also called Crest Anti-Cavity toothpaste
Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
| Study group | Role | What they receive |
|---|---|---|
| Total Flavor Option 1 | Experimental | Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1 Receives: Drug: Total Flavor option 1 |
| Total Flavor Option 2 | Experimental | Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2 Receives: Drug: Total Flavor option 2 |
| Crest Toothpaste | Placebo comparator | Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) Receives: Drug: Placebo toothpaste: Crest Cavity Protection toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaerobic Bacteria
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Measured: Baseline
Anaerobic Bacteria
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Measured: 12 hours
Malodor Bacteria (Breath Odor Causing Bacteria)
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Measured: Baseline
Malodor Bacteria (Breath Odor Causing Bacteria)
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
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 Oral Bacteria Levels in the MouthStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194621
- Sponsor's protocol ID
- CRO-1113-BACT-PS-NJ
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Center, Three Cell, Double Blind and Parallel Groups Clinical Study Conducted in Newark, NJ to Evaluate the Antibacterial Effects of Two Toothpastes Containing 0.3% Triclosan/2% Copolymer/0.243% Sodium Fluoride in a Silica Base as Compared to a Control Regular Fluoride Toothpaste on Oral Bacteria 12 Hours After 13 Days Product Use.
- ClinicalTrials.gov ID
- NCT02194621
- Acronym / sponsor ID
- CRO-1113-BACT-PS-NJ
- Conditions
- Oral Bacteria Levels in the Mouth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Posted 15 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total Flavor Option 1 | Experimental | Drug: Total Flavor option 1Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1 |
| Total Flavor Option 2 | Experimental | Drug: Total Flavor option 2Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2 |
| Crest Toothpaste | Placebo comparator | Drug: Placebo toothpaste: Crest Cavity Protection toothpastePlacebo toothpaste: Crest Cavity Protection toothpaste (currently marketed) |
Who may qualify
- Ages
- 22 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females in good general health aged 18 to 70 years.
- A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.
- A minimum of 20 natural teeth with facial and lingual scorable surfaces.
- Adequate oral hygiene and no signs of oral neglect.
- Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm.
Key exclusion criteria (14 listed)
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
- Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
- History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
- History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
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 |
|---|---|---|
| Total Flavor option 1Also: Total toothpasteTotal toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1 | Drug | Total Flavor Option 1 |
| Total Flavor option 2Also: Total toothpasteTotal toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2 | Drug | Total Flavor Option 2 |
| Placebo toothpaste: Crest Cavity Protection toothpasteAlso: Crest Anti-Cavity toothpastePlacebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed) | Drug | Crest Toothpaste |
Primary outcome
Anaerobic Bacteria
Time frame: Baseline
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Anaerobic Bacteria
Time frame: 12 hours
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
Malodor Bacteria (Breath Odor Causing Bacteria)
Time frame: Baseline
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Malodor Bacteria (Breath Odor Causing Bacteria)
Time frame: 12 hours
Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total Flavor option 1 and Total Flavor option 2 in people with Oral Bacteria Levels in the Mouth, 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 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 15 Apr 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Apr 2016). 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?
Anaerobic Bacteria (time frame: Baseline). The study lists 4 primary outcomes in all. 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 15 Apr 2016.