Gingivitis
Conditions
Brief summary
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice
Interventions
Twice daily usage
Twice daily usage
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be adult males or females 18 to 60 years old * Subjects must be able and willing to follow study procedures and instructions * Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination * Subjects must present with at least 20 teeth in the functional dentition, excluding third molars * Each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing
Exclusion criteria
* Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment * Subjects 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 * Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening * Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis * Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment * Subjects with orthodontic appliances or removable partial dentures * Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment * Subjects who currently smoke or who report using tobacco products within one year of screening. * Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment * Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis * Female subjects who report being pregnant * Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination. * Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis * Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator * Medical condition which precludes not eating/drinking for approximately 8 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours | 4 weeks | Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms) |
| Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours | 4 weeks | Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms) |
Countries
United States
Participant flow
Recruitment details
subjects were recruited by the PI at the clinical site
Participants by arm
| Arm | Count |
|---|---|
| Total Toothpaste (Active) triclosan/copolymer/fluoride toothpaste | 24 |
| Colgate Cavity Protection (Placebo) sodium monofluorophosphate toothpaste | 25 |
| Total | 49 |
Baseline characteristics
| Characteristic | Colgate Cavity Protection (Placebo) | Total Toothpaste (Active) | 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 | 25 Participants | 24 Participants | 49 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 12.1 | 39.9 years STANDARD_DEVIATION 12.5 | 36.25 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 24 | 6 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours
Levels of Gingival crevicular fluid Interleukin - 1 (GCF IL-1)(weight in micrograms)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste (Active) | Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours | 492.2 Micrograms | Standard Deviation 545.5 |
| Colgate Cavity Protection (Placebo) | Level of Gingival Crevicular Fluid Interleukin - 1 (GCF IL-1) at 2 Hours | 326.3 Micrograms | Standard Deviation 307.7 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours
Levels of Gingival crevicular fluid Interleukin - 6 (GCF IL-6) (weight in micrograms)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste (Active) | Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours | 12.8 Micrograms | Standard Deviation 23.3 |
| Colgate Cavity Protection (Placebo) | Level of Gingival Crevicular Fluid Interleukin - 6(GCF IL-6) at 2 Hours | 21.3 Micrograms | Standard Deviation 46.4 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA