Gingival Diseases
Conditions
Brief summary
Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation
Interventions
Brush twice daily
DRUGHerbal Ingredient and fluoride
Brush twice daily
DRUGFluoride
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 16 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. * Dental Selection Criteria: Average full mouth GI score should be in the range of * \- 2.0. heavy plaque formers should be avoided. Target a full mouth PI * (Quigley-Hein) to be in the range of 1.5-3.0 * If of child bearing potential and on birth control (diaphragm, birth control pills, * Birth control implants, IUD (Intrauterine device), condoms)
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 * 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 are 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. * History of allergy to common dentifrice ingredients * Presence of an orthodontic appliance which interferes with plaque scoring. * History of allergy to natural remedies, such as herbal ingredients * Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) * Smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Plaque | 6 weeks | Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored. |
| Gingivitis Score | 6 weeks | Gingivitis score (GI)= Units on a 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. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored. |
| Bleeding Index (EIBI) | 6 weeks | Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100. |
Countries
United States
Participant flow
Recruitment details
subjects were recruited by the PI at the clinical site
Pre-assignment details
subjects were screened for meeting medical and oral health criteria. Then completed a 1 week washout period with fluoride toothpaste prior to receiving any study treatments.
Participants by arm
| Arm | Count |
|---|---|
| A- Placebo Comparator Commercially available Fluoride toothpaste (Colgate Great Regular Flavor toothpaste) | 34 |
| B - Active Comparator fluoride/triclosan/copolymer toothpaste (Colgate Total toothpaste) | 34 |
| C - Experimental Toothpaste fluoride/herbal toothpaste | 35 |
| Total | 103 |
Baseline characteristics
| Characteristic | B - Active Comparator | C - Experimental Toothpaste | A- Placebo Comparator | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 34 Participants | 34 Participants | 102 Participants |
| Age Continuous | 42.68 years STANDARD_DEVIATION 11.83 | 40.8 years STANDARD_DEVIATION 11.7 | 40.3 years STANDARD_DEVIATION 12.2 | 41.3 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment United States | 34 participants | 35 participants | 34 participants | 103 participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 26 Participants | 74 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 8 Participants | 29 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 / 35 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 | 0 / 35 |
Outcome results
Primary
Bleeding Index (EIBI)
Eastman Interdental Bleeding Index Scores (EIBI) measures the number of interdental spaces that bleed, divided by number of interdental spaces studied to yield a score with a minimum of O and a maximum of 1 (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored and may be expressed as a percent when multiplied by 100.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A- Placebo Comparator | Bleeding Index (EIBI) | 0.325 Units on a scale | Standard Deviation 0.246 |
| B - Active Comparator | Bleeding Index (EIBI) | 0.164 Units on a scale | Standard Deviation 0.194 |
| C - Experimental Toothpaste | Bleeding Index (EIBI) | 0.141 Units on a scale | Standard Deviation 0.183 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05ANCOVA
Primary
Dental Plaque
Quigley Hein Method: 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. Plaque score= sum of all scores divided by the number of sites (teeth) scored.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A- Placebo Comparator | Dental Plaque | 2.273 Units on a scale | Standard Deviation 0.328 |
| B - Active Comparator | Dental Plaque | 1.806 Units on a scale | Standard Deviation 0.523 |
| C - Experimental Toothpaste | Dental Plaque | 2.041 Units on a scale | Standard Deviation 0.403 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05ANCOVA
Primary
Gingivitis Score
Gingivitis score (GI)= Units on a 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. GI scored=sum of GI scores divided by the number of sites (gingival gum line around the tooth)scored.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A- Placebo Comparator | Gingivitis Score | 0.942 Units on a scale | Standard Deviation 0.302 |
| B - Active Comparator | Gingivitis Score | 0.722 Units on a scale | Standard Deviation 0.369 |
| C - Experimental Toothpaste | Gingivitis Score | 0.705 Units on a scale | Standard Deviation 0.387 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: <0.05ANCOVA