Dental Plaque
Conditions
Brief summary
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.
Detailed description
This clinical research study was to train new examiners for short term plaque clinical methodologies.
Interventions
DRUGFluoride
Half mouth toothbrushing twice a day for four days.
Mouth rinsing with 15 ml for 30 seconds twice a day for four days.
Half mouth Brushing twice daily
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
23 Years to 81 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female volunteers at least 18 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). * Two 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 are currently affect salivary function. * Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * Allergy to chlorhexidine. * 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 pre-medication for dental treatment or for any other purpose. * Presence of an orthodontic appliance that interferes with plaque scoring. * History of allergy to common dentifrice ingredients. * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | Four days | Plaque 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) |
Countries
United States
Participant flow
Recruitment details
Recruitment was performed by the clinical site
Participants by arm
| Arm | Count |
|---|---|
| Fluoride Toothpaste negative control | 10 |
| Total Toothpaste triclosan/fluoride toothpaste (positive control toothpaste) | 9 |
| Chlorhexidine Oral Rinse chlorhexidine mouthrinse (positive control rinse) | 9 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Second Intervention | Lost to Follow-up | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total Toothpaste | Chlorhexidine Oral Rinse | Fluoride Toothpaste | 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 | 9 Participants | 9 Participants | 10 Participants | 28 Participants |
| Age Continuous | 39 years STANDARD_DEVIATION 9.2 | 47.2 years STANDARD_DEVIATION 9.6 | 47.6 years STANDARD_DEVIATION 15.1 | 44.5 years STANDARD_DEVIATION 11.7 |
| Region of Enrollment United States | 9 participants | 9 participants | 10 participants | 28 participants |
| Sex: Female, Male Female | 6 Participants | 9 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants | 6 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 | 1 / 28 | 1 / 28 | 1 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 28 |
Outcome results
Primary
Plaque Index
Plaque 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: Four days
Population: per protocol. 2 subjects missed appointments and did not complete two of the study treatment periods.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Toothpaste | Plaque Index | 2.63 Units on a scale | Standard Deviation 0.61 |
| Total Toothpaste | Plaque Index | 2.65 Units on a scale | Standard Deviation 0.56 |
| Chlorhexidine Oral Rinse | Plaque Index | 1.23 Units on a scale | Standard Deviation 0.59 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA