Mucositis
Conditions
Brief summary
Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.
Interventions
Brush twice daily
DRUGFluoride
Brush twice daily
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects, ages 30-70. * Availability for the six-month duration of the clinical research study. * Good general health. * Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants. * Minimum of 5 remaining teeth and a minimum of 2 implants. * Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing. * Initial plaque evaluation by determining full mouth presence/absence of plaque. * Signed Informed Consent Form.
Exclusion criteria
* Tumor(s) of the soft or hard tissues of the oral cavity. * Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone). * Carious lesions requiring immediate restorative treatment. * Uncontrolled Diabetes * Use of antibiotics any time during the one month prior to entry into the study. * Untreated peri-implantitis. * Participation in any other clinical research study or test panel within the three months prior to entry into the study. * Pregnant women or women who are breast feeding. * History of allergies to personal care/consumer products or their ingredients. * Medical condition which prohibits not eating/drinking for up to 2 hours. * Current alcohol or drug abuse. * Systemic or local disease conditions that would compromise post-operative healing. * Regular use of anti-inflammatory drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing | 6 months | Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 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. |
| Mean Pocket Depth | 6 Months | Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth. |
| Mean Percentage of Plaque Scores | 6 Months | Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Toothpaste Triclosan/copolymer/Fluoride | 30 |
| Ultrabrite Toothpaste sodium fluoride control (placebo) | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Ultrabrite Toothpaste | Total Toothpaste | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 26 Participants | 52 Participants |
| Age Continuous | 57.83 years STANDARD_DEVIATION 7.97 | 57.36 years STANDARD_DEVIATION 7.38 | 57.59 years STANDARD_DEVIATION 7.61 |
| Region of Enrollment Italy | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Primary
Bleeding on Probing
Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Bleeding on Probing | 53.8 Percentage of bleeding sites | Standard Deviation 17.6 |
| Ultrabrite Toothpaste | Bleeding on Probing | 52.3 Percentage of bleeding sites | Standard Deviation 24.6 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA
Primary
Mean Percentage of Plaque Scores
Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Mean Percentage of Plaque Scores | 13.2 percentage of dental plaque | Standard Deviation 15.6 |
| Ultrabrite Toothpaste | Mean Percentage of Plaque Scores | 16.0 percentage of dental plaque | Standard Deviation 17.8 |
Comparison: The null hypothesis states that there is no difference between groupsp-value: 0.05ANCOVA
Primary
Mean Pocket Depth
Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Toothpaste | Mean Pocket Depth | 4.4 Millimeters | Standard Deviation 0.6 |
| Ultrabrite Toothpaste | Mean Pocket Depth | 4.5 Millimeters | Standard Deviation 0.5 |
Comparison: The null hypothesis states that there is no difference between groups.p-value: 0.05ANCOVA