GingivitisNCT01799226
Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
A study testing Toothpaste without triclosan and Triclosan in people with Gingivitis, run by University of Michigan at 1 site in United States.
Trial summary
This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Toothpaste without triclosan and Triclosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2013
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Race - all
- Gender - female or male
- Age - 18 to 40 years old
- Dentition - minimum of 20 permanent teeth
- Probing Pocket Depth of 1-4mm in all sites
- Mean Clinical Attachment Levels of 2mm on all teeth
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- Bleeding Upon Probing of greater than 30% at Day -14 Study Visit
- Consent Form - read, understood, and signed
- Study Procedures - willing to follow all study procedures
- At Day 0 Study Visit, all subjects must have a BOP of less than 10%. Subjects not meeting the BOP study criteria will be asked to return in 2 weeks for a second assessment visit. Subjects who do not meet the inclusion criteria
- BOP less than 10% at the second assessment visit will be exited from the
- study
Who cannot join
- Medical History - a history of alcoholism or drug abuse
- Diseases of the immune system
- Medical condition that may affect outcome (neurologic or psychiatric disorders, systemic infection
- Medications - chronic medications known to affect the periodontal status (calcium antagonists anticonvulsives, immunosuppressives, anti-inflammatory medications, phenytoin, Depo-Provera contraceptive injection users
- New oral contraceptives users within 3 months of baseline or are planning on starting oral contraceptives during the study
- Hypersensitivity - previous known reaction to or oral allergy to any ingredient in the study toothpaste
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- Antibiotics - antibiotic therapy within 3 months of baseline visit
- antibiotic therapy needed for infective endocarditis prophylaxis or total joint replacement
- Use of antiseptics - homecare regime using products to control dental plaque formation within 30 days prior to baseline visit
- Smoking - current smokers, smokers who quit smoking less than one year ago, or a pack-year history of more than or equal to 10 (pack-years will be calculated by multiplying the number of years smoked by the average number of cigarette packs smoked per day)
- Continine - positive urine analysis results
- Current Dental Treatment - orthodontic or periodontal treatment
- Untreated Dental Treatment - untreated carious lesions
- Defective restorations which could exacerbate during a period of oral hygiene abstinence
- Pregnant or women breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.
Read the detailed description
This will be a double-blind. Subjects will be randomly assigned to the test or control dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.
During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain from all hygiene procedures in the stent area. During this time period, participants evenly distributed 2mL of their assigned dentifrice into their stent, allowing it to come into contact with the areas of experimental gingivitis for two minutes twice daily while traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva, gingival crevicular fluid and plaque samples will be collected at days 0, 14, 21, and 35 study visits. A randomization chart will be used to identify which two sites (teeth and tooth surface) will be used at the specific study visit for collection of gingival crevicular fluid(GCF) and plaque.
- Conditions
- Gingivitis
- Being tested
- Toothpaste without triclosan, Triclosan
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste without triclosanOther
this intervention will use a toothpaste without triclosan
TriclosanOther
Also called Colgate total toothpaste
this intervention will use Colgate Total which contains triclosan
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste without Triclosan | Active comparator | This arm will use a toothpaste that does not contain triclosan Receives: Other: Toothpaste without triclosan |
| Triclosan | Experimental | This arm will use colgate total which contains triclosan Receives: Other: Triclosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Silness \& Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.
Measured: Baseline to 35 Days
Secondary outcomes (1)
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Loe \& Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.
Measured: Baseline to 35 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Kinney, University of Michigan
- Investigators
- Janet Kinney, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799226
- Sponsor's protocol ID
- HUM00055445
- Status last verified
- Jan 2016
- First submitted
- 24 Feb 2013
- Last updated
- 13 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pancer BA, Kott D, Sugai JV, Panagakos FS, Braun TM, Teles RP, Giannobile WV, Kinney JS. Effects of triclosan on host response and microbial biomarkers during experimental gingivitis. J Clin Periodontol. 2016 May;43(5):435-44. doi: 10.1111/jcpe.12519. Epub 2016 Apr 6.
PubMed 26820239
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Anti-Inflammatory Effects of Colgate Total® During an Experimental Gingivitis Model
- ClinicalTrials.gov ID
- NCT01799226
- Acronym / sponsor ID
- HUM00055445
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Posted 13 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.
Detailed description
This will be a double-blind. Subjects will be randomly assigned to the test or control dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.
During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain from all hygiene procedures in the stent area. During this time period, participants evenly distributed 2mL of their assigned dentifrice into their stent, allowing it to come into contact with the areas of experimental gingivitis for two minutes twice daily while traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva, gingival crevicular fluid and plaque samples will be collected at days 0, 14, 21, and 35 study visits. A randomization chart will be used to identify which two sites (teeth and tooth surface) will be used at the specific study visit for collection of gingival crevicular fluid(GCF) and plaque.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothpaste without Triclosan | Active comparator | Other: Toothpaste without triclosanThis arm will use a toothpaste that does not contain triclosan |
| Triclosan | Experimental | Other: TriclosanThis arm will use colgate total which contains triclosan |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Race - all
- Gender - female or male
- Age - 18 to 40 years old
- Dentition - minimum of 20 permanent teeth
- Probing Pocket Depth of 1-4mm in all sites
Key exclusion criteria (15 listed)
- Medical History - a history of alcoholism or drug abuse
- Diseases of the immune system
- Medical condition that may affect outcome (neurologic or psychiatric disorders, systemic infection
- Medications - chronic medications known to affect the periodontal status (calcium antagonists anticonvulsives, immunosuppressives, anti-inflammatory medications, phenytoin, Depo-Provera contraceptive injection users
- New oral contraceptives users within 3 months of baseline or are planning on starting oral contraceptives during the study
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 |
|---|---|---|
| Toothpaste without triclosanthis intervention will use a toothpaste without triclosan | Other | Toothpaste without Triclosan |
| TriclosanAlso: Colgate total toothpastethis intervention will use Colgate Total which contains triclosan | Other | Triclosan |
Primary outcome
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35
Time frame: Baseline to 35 Days
Silness \& Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.
1 secondary outcome
Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35
Time frame: Baseline to 35 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26820239Pancer BA, Kott D, Sugai JV, Panagakos FS, Braun TM, Teles RP, Giannobile WV, Kinney JS. Effects of triclosan on host response and microbial biomarkers during experimental gingivitis. J Clin Periodontol. 2016 May;43(5):435-44. doi: 10.1111/jcpe.12519. Epub 2016 Apr 6.
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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.
Janet Kinney, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste without triclosan and Triclosan in people with Gingivitis, run by University of Michigan 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 12 inclusion and 15 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 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 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?
Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 (time frame: Baseline to 35 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799226, which also lists 1 linked publication.
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 Jan 2016.