Back to resultsClinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
Primary Purpose
Periodontal Disease, Systemic Inflammatory Markers
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Triclosan Containing Toothpaste
Triclosan Free Toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
triclosan free toothpaste
Triclosan containing toothpaste
Arm Description
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
Outcomes
Primary Outcome Measures
Periodontal Pocket Depth (PPD)
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)
Periodontal Pocket Depth (PPD)
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)
Periodontal Pocket Depth (PPD)
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)
Periodontal Pocket Depth (PPD)
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)
Clinical Attachment Loss (CAL)
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)
Clinical Attachment Loss (CAL)
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)
Clinical Attachment Loss (CAL)
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)
Clinical Attachment Loss (CAL)
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)
C Reactive Protein (CRP)
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.
C Reactive Protein (CRP)
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.
C Reactive Protein (CRP)
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.
C Reactive Protein (CRP)
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.
Interleukin-1 Beta ( IL-1β)
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
Interleukin-1 Beta (IL-1β)
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
Interleukin-1 Beta (IL-1β)
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
Interleukin-1 Beta (IL- 1β)
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
Tumor necrosis factor - alfa (TNF-α)
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.
Tumor necrosis factor - alfa (TNF-α)
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.
Tumor necrosis factor - alfa (TNF-α)
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.
Tumor necrosis factor - alfa (TNF-α)
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.
Prostaglandin E2 (PGE 2)
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
Prostaglandin E2 (PGE 2)
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
Prostaglandin E2 (PGE 2)
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
Prostaglandin E2 (PGE 2)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02670135
Brief Title
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
Official Title
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Colgate Palmolive
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Systemic Inflammatory Markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
triclosan free toothpaste
Arm Type
Placebo Comparator
Arm Description
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
Arm Title
Triclosan containing toothpaste
Arm Type
Active Comparator
Arm Description
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
Intervention Type
Drug
Intervention Name(s)
Triclosan Containing Toothpaste
Other Intervention Name(s)
Active comparator, Total Toothpaste
Intervention Description
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
Intervention Type
Drug
Intervention Name(s)
Triclosan Free Toothpaste
Other Intervention Name(s)
Control toothpaste
Intervention Description
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
Primary Outcome Measure Information:
Title
Periodontal Pocket Depth (PPD)
Description
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)
Time Frame
baseline
Title
Periodontal Pocket Depth (PPD)
Description
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)
Time Frame
2 months
Title
Periodontal Pocket Depth (PPD)
Description
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)
Time Frame
6 months
Title
Periodontal Pocket Depth (PPD)
Description
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)
Time Frame
12 months
Title
Clinical Attachment Loss (CAL)
Description
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)
Time Frame
baseline
Title
Clinical Attachment Loss (CAL)
Description
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)
Time Frame
2 months
Title
Clinical Attachment Loss (CAL)
Description
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)
Time Frame
6 months
Title
Clinical Attachment Loss (CAL)
Description
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)
Time Frame
12 months
Title
C Reactive Protein (CRP)
Description
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.
Time Frame
baseline
Title
C Reactive Protein (CRP)
Description
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.
Time Frame
2 months
Title
C Reactive Protein (CRP)
Description
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.
Time Frame
6 months
Title
C Reactive Protein (CRP)
Description
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.
Time Frame
12 months
Title
Interleukin-1 Beta ( IL-1β)
Description
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
Time Frame
baseline
Title
Interleukin-1 Beta (IL-1β)
Description
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
Time Frame
2 months
Title
Interleukin-1 Beta (IL-1β)
Description
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
Time Frame
6 months
Title
Interleukin-1 Beta (IL- 1β)
Description
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
Time Frame
12 months
Title
Tumor necrosis factor - alfa (TNF-α)
Description
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.
Time Frame
baseline
Title
Tumor necrosis factor - alfa (TNF-α)
Description
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.
Time Frame
2 months
Title
Tumor necrosis factor - alfa (TNF-α)
Description
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.
Time Frame
6 months
Title
Tumor necrosis factor - alfa (TNF-α)
Description
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.
Time Frame
12 months
Title
Prostaglandin E2 (PGE 2)
Description
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
Time Frame
baseline
Title
Prostaglandin E2 (PGE 2)
Description
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
Time Frame
2 months
Title
Prostaglandin E2 (PGE 2)
Description
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
Time Frame
6 months
Title
Prostaglandin E2 (PGE 2)
Description
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
Time Frame
12 moths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
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