Gingival Diseases
Conditions
Brief summary
The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.
Detailed description
The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.
Interventions
DRUGFluoride
Brush twice daily
Half mouth toothbrushing twice daily for 4 days
DRUGChlorhexidine Gluconate
Mouth rinsing twice a day for 4 days
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
* Subjects 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 or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions * 2 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 can 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. * Allergy to chlorhexidine * 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. * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Plaque Index | 4-Day | Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth) |
Countries
United States
Participant flow
Recruitment details
At clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride | 8 |
| Fluoride/Triclosan | 8 |
| Chlorhexidine Gluconate | 9 |
| Total | 25 |
Baseline characteristics
| Characteristic | Fluoride/Triclosan | Chlorhexidine Gluconate | Fluoride | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 9 Participants | 8 Participants | 25 Participants |
| Age Continuous | 32.6 years STANDARD_DEVIATION 8.8 | 33.1 years STANDARD_DEVIATION 9 | 29.4 years STANDARD_DEVIATION 6.9 | 31.8 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 8 participants | 9 participants | 8 participants | 25 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 8 Participants | 23 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants | 2 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 | 6 / 9 | 1 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 9 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Dental Plaque Index
Scale 0 to 5 (zero= no plaque to 5 = plaque covering 2/3 or more of the crown of the tooth)
Time frame: 4-Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride | Dental Plaque Index | 2.79 Units on a scale | Standard Deviation 0.37 |
| Fluoride/Triclosan | Dental Plaque Index | 2.82 Units on a scale | Standard Deviation 0.39 |
| Chlorhexidine Gluconate | Dental Plaque Index | 1.99 Units on a scale | Standard Deviation 0.41 |
p-value: <0.05ANOVA