Gingivitis
Conditions
Keywords
Gingivitis and Plaque
Brief summary
The objective of this study is to evaluate the performance of two toothpastes in controlling established gingivitis and dental plaque in adults.
Interventions
Six Month study, brush twice daily
DRUGFluoride
twice daily usage
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Availability for the six-month duration of the study. * Good general health. * Minimum of 20 uncrowned permanent natural teeth (excluding third molars). * Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index. * Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification). * Signed Informed Consent Form.
Exclusion criteria
* Presence of orthodontic bands. * Presence of partial removable dentures. * Tumor(s) of the soft or hard tissues of the oral cavity. * Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss of * periodontal attachment or alveolar bone). * Five or more carious lesions requiring immediate restorative treatment. * Use of antibiotics any time during the one month prior to entry into the study. * Participation in any other clinical study or test panel within the one month prior to entry * into the study. * Pregnant women or women who are breast feeding. * Receive a dental prophylaxis in the past two weeks prior to baseline examinations. * History of allergic to personal care/consumer products or their ingredients. * Taking any prescription medicines. That might interfere with the study outcome. * Individuals with an existing medical condition which prohibits them from not eating or drinking for periods up to 4 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingivitis Index | 6 months | 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) |
| Plaque Index | 6 Months | 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
Spain
Participant flow
Recruitment details
Performed by the Research Department School of Dentistry UPR
Participants by arm
| Arm | Count |
|---|---|
| Experimental Treatment triclosan/copolymer/fluoride toothpaste | 60 |
| Placebo Control sodium fluoride toothpaste | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 14 |
Baseline characteristics
| Characteristic | Placebo Control | Experimental Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 58 Participants | 116 Participants |
| Age Continuous | 35.95 years STANDARD_DEVIATION 10.24 | 34.72 years STANDARD_DEVIATION 8.51 | 35.33 years STANDARD_DEVIATION 9.39 |
| Region of Enrollment Spain | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 43 Participants | 45 Participants | 88 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Gingivitis Index
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)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Treatment | Gingivitis Index | 1.00 Units on a scale | Standard Deviation 0.17 |
| Placebo Control | Gingivitis Index | 1.27 Units on a scale | Standard Deviation 0.28 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Plaque Index
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: 6 Months
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Treatment | Plaque Index | 2.22 Units on a scale | Standard Deviation 0.49 |
| Placebo Control | Plaque Index | 2.88 Units on a scale | Standard Deviation 0.52 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA