Gingival Diseases
Conditions
Brief summary
Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment
Interventions
DRUGFluoride
Brush twice daily
Brush twice daily
OTHERantibacterial plant extract
Brush twice daily
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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. * Must discontinue oral hygiene on the mornings of each appointment and between sampling periods. * 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
* Medical condition which requires pre-medication prior to dental procedures/visits. * Medical condition which precludes eating/drinking for 12 hrs. * History of allergy to common dentifrice ingredients. * Subjects unable or unwilling to sign the informed consent form. * Moderate or advanced periodontal disease. * 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 can currently affect salivary flow. * Current use of antibiotics. * 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 30 days 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. * Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | 8 weeks | Plaque score scale: Units on a 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
The dental clinic staff recruited for this study.
Participants by arm
| Arm | Count |
|---|---|
| Fluoride Control, Magnolol,Total/Whitening,Honokiol 1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol | 6 |
| Total/Whitening, Honokiol, Fluoride Control, Magnolol 1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol | 6 |
| Honokiol, Fluoride Control, Magnolol, Total/Whitening 1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control | 6 |
| Magnolol, Total/Whitening, Honokiol, Fluoride Control 1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control | 7 |
| Total | 25 |
Baseline characteristics
| Characteristic | Total/Whitening, Honokiol, Fluoride Control, Magnolol | Honokiol, Fluoride Control, Magnolol, Total/Whitening | Fluoride Control, Magnolol,Total/Whitening,Honokiol | Magnolol, Total/Whitening, Honokiol, Fluoride Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 25 Participants |
| Age Continuous | 37.8 years STANDARD_DEVIATION 11.6 | 46.4 years STANDARD_DEVIATION 10.9 | 42 years STANDARD_DEVIATION 11.8 | 44.3 years STANDARD_DEVIATION 7 | 42.1 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 6 participants | 6 participants | 6 participants | 7 participants | 25 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 2 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 4 Participants | 0 Participants | 10 Participants |
Outcome results
Primary
Plaque Index
Plaque score scale: Units on a 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: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluoride Only | Plaque Index | 2.45 Units on a scale | Standard Deviation 0.47 |
| Total/Whitening | Plaque Index | 2.22 Units on a scale | Standard Deviation 0.46 |
| Herbal Extract Toothpaste | Plaque Index | 2.54 Units on a scale | Standard Deviation 0.44 |
| Herbal Extract Toothpaste | Plaque Index | 2.56 Units on a scale | Standard Deviation 0.46 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANOVA