Gingival Diseases
Conditions
Brief summary
To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.
Interventions
DRUGFluoride
Brush twice daily for 6 weeks
Brush twice daily
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
26 Years to 68 Years
Healthy volunteers
Yes
Inclusion criteria
* Be aged 18 to 65 years inclusive * Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present * Give written informed consent * Be in good general health * No known history of allergy to personal care/consumer products or their * ingredients, relevant to any ingredients in the test products as determined by the * dental/medical professional monitoring the study
Exclusion criteria
* Medical condition which requires pre-medication prior to dental visits/procedures * Advanced periodontal disease * 5 or more decayed, untreated dental sites * Diseases of the soft or hard oral tissues * Orthodontic appliances * Abnormal salivary function * Use of prescription drugs. * Use of antibiotics one (1) month prior to or during this study * Use of any over the counter medications other than analgesics * Erratic use of vitamin supplements * Pregnant or breastfeeding. * Participation in another clinical study in the month preceding this study * Allergic to common dentifrice ingredients * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolite Associated With Inflammation (Cadaverine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Choline) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Hypoxanthine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Inosine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Isoleucine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Leucine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Lysine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Phenylalanine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Putrescine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment. |
| Metabolite Associated With Inflammation (Xanthine) | 6 weeks | One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment. |
Countries
United States
Participant flow
Recruitment details
subjects were recruited by the PI at the clinical site
Pre-assignment details
Subjects were screened to meet medical and oral health criteria and then began a 1 week washout period with fluoride toothpaste.
Participants by arm
| Arm | Count |
|---|---|
| A - Control Comparator Participants brushed their teeth with the fluoride only control toothpaste two times a day for six weeks. | 21 |
| B - Active Comparator Participants rinsed their teeth with the Active Comparator toothpaste (fluoride/triclosan/copolymer) two times a day for six weeks. | 18 |
| Total | 39 |
Baseline characteristics
| Characteristic | B - Active Comparator | A - Control Comparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 21 Participants | 39 Participants |
| Age Continuous | 49.8 years STANDARD_DEVIATION 12.8 | 48 years STANDARD_DEVIATION 12.7 | 48.9 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment United States | 18 participants | 21 participants | 39 participants |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 16 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 18 |
| serious Total, serious adverse events | 0 / 21 | 0 / 18 |
Outcome results
Primary
Metabolite Associated With Inflammation (Cadaverine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Cadaverine) | 1.119186 ion count | Standard Deviation 0.834969 |
| B - Active Comparator | Metabolite Associated With Inflammation (Cadaverine) | 0.92077 ion count | Standard Deviation 0.78476 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Choline)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Choline) | 1.2264 ion count | Standard Deviation 0.79066 |
| B - Active Comparator | Metabolite Associated With Inflammation (Choline) | 1.169513 ion count | Standard Deviation 0.79071 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Hypoxanthine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Hypoxanthine) | 0.76984 ion count | Standard Deviation 0.58459 |
| B - Active Comparator | Metabolite Associated With Inflammation (Hypoxanthine) | 0.701628 ion count | Standard Deviation 0.63887 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Inosine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Inosine) | 1.11183 ion count | Standard Deviation 1.05685 |
| B - Active Comparator | Metabolite Associated With Inflammation (Inosine) | 0.84462 ion count | Standard Deviation 0.99409 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Isoleucine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Isoleucine) | 1.20033 ion count | Standard Deviation 0.61108 |
| B - Active Comparator | Metabolite Associated With Inflammation (Isoleucine) | 1.048449 ion count | Standard Deviation 0.70947 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Leucine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Leucine) | 1.10064 ion count | Standard Deviation 0.5424 |
| B - Active Comparator | Metabolite Associated With Inflammation (Leucine) | 1.018989 ion count | Standard Deviation 0.64132 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Lysine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Lysine) | 1.063873 ion count | Standard Deviation 0.785917 |
| B - Active Comparator | Metabolite Associated With Inflammation (Lysine) | 1.09704 ion count | Standard Deviation 1.149168 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Phenylalanine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Phenylalanine) | 1.16994 ion count | Standard Deviation 0.56433 |
| B - Active Comparator | Metabolite Associated With Inflammation (Phenylalanine) | 1.057373 ion count | Standard Deviation 0.62511 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Putrescine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Putrescine) | 1.050398 ion count | Standard Deviation 0.69913 |
| B - Active Comparator | Metabolite Associated With Inflammation (Putrescine) | 0.74134 ion count | Standard Deviation 0.86837 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05t-test, 1 sided
Primary
Metabolite Associated With Inflammation (Xanthine)
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A - Control Comparator | Metabolite Associated With Inflammation (Xanthine) | 1.05189 ion count | Standard Deviation 0.615226 |
| B - Active Comparator | Metabolite Associated With Inflammation (Xanthine) | 1.011732 ion count | Standard Deviation 0.96834 |