- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02670135
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
February 21, 2019 updated by: Colgate Palmolive
This is a single center, double blinded, randomized, controlled trial.
Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to comparatively evaluate the effects of Colgate Total® toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed.
Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will be assessed at baseline and after 2, 6 and 12 months of product use.
Peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).
Study Type
Interventional
Enrollment (Actual)
303
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject males or females 18 to 50 years old.
- Availability for the 12 months duration of the clinical research study.
- Subject able and willing to follow study procedures and instructions.
- Subject read, understood and signed an informed consent form.
- Subject present with at least 20 natural teeth in the functional dentition (excluding third molars).
- Initial probing pocket depth of >4mm in at least one tooth/quadrant.
- Good general health.
- Subjects willing to disclose information on medication.
Exclusion Criteria:
- Subject with concomitant periodontal therapy 6 months prior to enrollment.
- Subject with orthodontic appliances.
- Subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination*.
- Subject treated with antibiotics within 3 months prior to enrollment.
- Subject necessitating antibiotic prophylaxis.
- Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator*.
- Subject with known allergy to oral care products or ingredients in oral care products.
- Subject with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity (determined by the examiner).
- Subject diagnosed with aggressive periodontitis or acute necrotizing ulcerative gingivitis.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Subject pregnant at point of enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: triclosan free toothpaste
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
|
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
Other Names:
|
ACTIVE_COMPARATOR: Triclosan containing toothpaste
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
|
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periodontal Pocket Depth (PPD)
Time Frame: baseline
|
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013).
The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
|
baseline
|
Periodontal Pocket Depth (PPD)
Time Frame: 2 months
|
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013).
The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
|
2 months
|
Periodontal Pocket Depth (PPD)
Time Frame: 6 months
|
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013).
The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
|
6 months
|
Periodontal Pocket Depth (PPD)
Time Frame: 12 months
|
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013).
The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
|
12 months
|
Clinical Attachment Loss (CAL)
Time Frame: baseline
|
Attachment lost will be measured from index teeth as described in WHO (2013).
Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
|
baseline
|
Clinical Attachment Loss (CAL)
Time Frame: 2 months
|
Attachment lost will be measured from index teeth as described in WHO (2013).
Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
|
2 months
|
Clinical Attachment Loss (CAL)
Time Frame: 6 months
|
Attachment lost will be measured from index teeth as described in WHO (2013).
Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
|
6 months
|
Clinical Attachment Loss (CAL)
Time Frame: 12 months
|
Attachment lost will be measured from index teeth as described in WHO (2013).
Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
|
12 months
|
C Reactive Protein (CRP)
Time Frame: baseline
|
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body.
Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease.
The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
|
baseline
|
C Reactive Protein (CRP)
Time Frame: 2 months
|
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body.
Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease.
The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
|
2 months
|
C Reactive Protein (CRP)
Time Frame: 6 months
|
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body.
Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease.
The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
|
6 months
|
C Reactive Protein (CRP)
Time Frame: 12 months
|
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body.
Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease.
The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
|
12 months
|
Interleukin-1 Beta ( IL-1β)
Time Frame: baseline
|
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer
|
baseline
|
Interleukin-1 Beta (IL-1β)
Time Frame: 2 months
|
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer
|
2 months
|
Interleukin-1 Beta (IL-1β)
Time Frame: 6 months
|
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer
|
6 months
|
Interleukin-1 Beta (IL- 1β)
Time Frame: 12 months
|
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer
|
12 months
|
Tumor necrosis factor - alfa (TNF-α)
Time Frame: baseline
|
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge.
Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
|
baseline
|
Tumor necrosis factor - alfa (TNF-α)
Time Frame: 2 months
|
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge.
Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
|
2 months
|
Tumor necrosis factor - alfa (TNF-α)
Time Frame: 6 months
|
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge.
Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
|
6 months
|
Tumor necrosis factor - alfa (TNF-α)
Time Frame: 12 months
|
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge.
Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
|
12 months
|
Prostaglandin E2 (PGE 2)
Time Frame: baseline
|
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
|
baseline
|
Prostaglandin E2 (PGE 2)
Time Frame: 2 months
|
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
|
2 months
|
Prostaglandin E2 (PGE 2)
Time Frame: 6 months
|
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
|
6 months
|
Prostaglandin E2 (PGE 2)
Time Frame: 12 moths
|
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease.
Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
|
12 moths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (ACTUAL)
July 1, 2016
Study Completion (ACTUAL)
August 1, 2016
Study Registration Dates
First Submitted
January 28, 2016
First Submitted That Met QC Criteria
January 29, 2016
First Posted (ESTIMATE)
February 1, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 21, 2019
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRO-2014-09-CT-ISR-DB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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