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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
303
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
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)
Time frame: baseline
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)
Time frame: 2 months
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)
Time frame: 6 months
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)
Time frame: 12 months
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline
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)
Time frame: 2 months
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)
Time frame: 6 months
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)
Time frame: 12 months
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.
Time frame: baseline
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.
Time frame: 2 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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
Time frame: baseline
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
Time frame: 2 months
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
Time frame: 6 months
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
Time frame: 12 months
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.
Time frame: baseline
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.
Time frame: 2 months
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.
Time frame: 6 months
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.
Time frame: 12 months
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
Time frame: baseline
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
Time frame: 2 months
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
Time frame: 6 months
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
Time frame: 12 moths