Dental Plaque
Conditions
Brief summary
Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.
Interventions
DRUGFluoride
Brush twice daily
Brush twice daily
OTHERMetal salt
Brush twice daily
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteers 18-65 years of age. * Good general health. * Must sign informed consent form. * Minimum of 20 natural uncrowned teeth (excluding third molars) must be present. * No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
Exclusion criteria
* Subject unable or unwilling to sign the informed consent form. * Medical condition which requires pre-medication prior to dental visits/procedures. * Moderate or advanced periodontal disease. * 5 or more decayed untreated dental sites at screening. * Other disease of the hard or soft oral tissues. * Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation). * Use of medications that currently affect salivary flow. * Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * Pregnant or nursing women. * Participation in any other clinical study within 1 week prior to enrollment into this study. * Use of tobacco products. * Subjects who must receive dental treatment during the study dates. * Current use of Antibiotics for any purpose. * Presence of an orthodontic appliance. * History of allergy to common dentifrice ingredients. * History of allergy to zinc. * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 6 weeks | Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth) |
| Gingivitis Index | 6 Weeks | Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding) |
Countries
United States
Participant flow
Recruitment details
At the clinical site
Participants by arm
| Arm | Count |
|---|---|
| Placebo Control fluoride toothpaste | 34 |
| Positive Control triclosan/fluoride toothpaste | 34 |
| Experimental triclosan/fluoride/zinc toothpaste | 34 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Positive Control | Experimental | Placebo Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 34 Participants | 34 Participants | 102.0 Participants |
| Age Continuous | 46.4 years STANDARD_DEVIATION 10.5 | 48.9 years STANDARD_DEVIATION 9.5 | 46.7 years STANDARD_DEVIATION 11.2 | 47.4 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 34 participants | 34 participants | 34 participants | 102.0 participants |
| Sex: Female, Male Female | 26 Participants | 29 Participants | 25 Participants | 80.0 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 9 Participants | 22.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 | 0 / 34 |
Outcome results
Primary
Gingivitis Index
Gingivitis score- scale 0 to 3 (0 = no inflammation,1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Time frame: 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Control | Gingivitis Index | 0.63 Units on a scale | Standard Deviation 0.15 |
| Positive Control | Gingivitis Index | 0.51 Units on a scale | Standard Deviation 0.17 |
| Experimental | Gingivitis Index | 0.98 Units on a scale | Standard Deviation 0.15 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA
Primary
Plaque Index
Plaque Index score scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Control | Plaque Index | 0.91 Units on a scale | Standard Deviation 0.91 |
| Positive Control | Plaque Index | 0.84 Units on a scale | Standard Deviation 0.25 |
| Experimental | Plaque Index | 1.77 Units on a scale | Standard Deviation 0.44 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA