Dental Plaque
Conditions
Keywords
dental, dentist, plaque, IP Cleaning
Brief summary
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
Interventions
DEVICEManual Toothbrush
A standard size manual toothbrush to clean visible tooth surfaces
DEVICEInterproximal Cleaning Device
An electronic device that combines water and air to clean between the teeth
Sponsors
Philips Oral Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* are in good/excellent health; * are 18 - 70 years old; * have a minimum of 20 natural teeth (excluding 3rd molars); * have sufficient test sites; * have ≥ 20 bleeding sites; * are willing to participate and available for participation.
Exclusion criteria
* have systemic diseases such as Down's syndrome, or known AIDS/HIV; * have insulin dependant Diabetes; * are pregnant or nursing by subject report; * have a cardiac pacemaker * are undergoing or require extensive dental or orthodontic treatment; * require antibiotic treatment for dental appointments; * have heavy deposits of calculus; * have severe gingivitis or periodontitis; * have extensive crown or bridge work and/or rampant decay; * currently use bleaching trays; * have any oral or extraoral piercing on lips or in mouth; * have a professional prophylaxis within 4 weeks of study; * participation in a prior study ≤ 20 days; * employed by a oral healthcare products company or research institution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Protein Concentration | 14 days | Residual protein concentration of interproximal plaque samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual Protein Concentration | 28 days | Residual protein concentration of interproximal plaque samples |
| Modified Gingival Index | 14 days | Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst) |
| Gingival Bleeding Index | 14 days | Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Toothbrush 1 Manual Toothbrush used for 1 minute twice a day. | 11 |
| Manual Toothbrush 2 Manual Toothbrush used for 2 minutes twice a day. | 72 |
| Manual Toothbrush + Interproximal Cleaning 1 Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day. | 74 |
| Manual Toothbrush + Interproximal Cleaning 2 Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day. | 11 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Manual Toothbrush 1 | Manual Toothbrush 2 | Manual Toothbrush + Interproximal Cleaning 1 | Manual Toothbrush + Interproximal Cleaning 2 | Total |
|---|---|---|---|---|---|
| Age Continuous | 38.5 years STANDARD_DEVIATION 12.6 | 39.6 years STANDARD_DEVIATION 11.6 | 39.6 years STANDARD_DEVIATION 10.9 | 41.2 years STANDARD_DEVIATION 12.8 | 39.6 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 8 Participants | 48 Participants | 48 Participants | 8 Participants | 112 Participants |
| Sex: Female, Male Male | 3 Participants | 24 Participants | 26 Participants | 3 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 73 | 0 / 75 | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 73 | 1 / 75 | 0 / 11 |
Outcome results
Primary
Residual Protein Concentration
Residual protein concentration of interproximal plaque samples
Time frame: 14 days
Population: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Manual Toothbrush 1 | Residual Protein Concentration | 33.5 ug/mL |
| Manual Toothbrush 2 | Residual Protein Concentration | 28 ug/mL |
| Manual Toothbrush + Interproximal Cleaning 1 | Residual Protein Concentration | 20.4 ug/mL |
| Manual Toothbrush + Interproximal Cleaning 2 | Residual Protein Concentration | 20.2 ug/mL |
Secondary
Gingival Bleeding Index
Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)
Time frame: 14 days
Population: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Manual Toothbrush 1 | Gingival Bleeding Index | 0.36 units on a scale |
| Manual Toothbrush 2 | Gingival Bleeding Index | 0.26 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 1 | Gingival Bleeding Index | 0.18 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 2 | Gingival Bleeding Index | 0.19 units on a scale |
Secondary
Gingival Bleeding Index
Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)
Time frame: 28 days
Population: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Manual Toothbrush 1 | Gingival Bleeding Index | 0.3 units on a scale |
| Manual Toothbrush 2 | Gingival Bleeding Index | 0.26 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 1 | Gingival Bleeding Index | 0.16 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 2 | Gingival Bleeding Index | 0.2 units on a scale |
Secondary
Modified Gingival Index
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Time frame: 14 days
Population: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Manual Toothbrush 1 | Modified Gingival Index | 1.45 units on a scale |
| Manual Toothbrush 2 | Modified Gingival Index | 1.48 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 1 | Modified Gingival Index | 1.26 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 2 | Modified Gingival Index | 1.39 units on a scale |
Secondary
Modified Gingival Index
Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)
Time frame: 28 days
Population: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Manual Toothbrush 1 | Modified Gingival Index | 1.35 units on a scale |
| Manual Toothbrush 2 | Modified Gingival Index | 1.44 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 1 | Modified Gingival Index | 1.23 units on a scale |
| Manual Toothbrush + Interproximal Cleaning 2 | Modified Gingival Index | 1.41 units on a scale |
Secondary
Residual Protein Concentration
Residual protein concentration of interproximal plaque samples
Time frame: 28 days
Population: Analysis of efficacy data was performed using a modified intent-to-treat population (MITT). The MITT Population included all randomized subjects with both a baseline and endpoint evaluation. Missing data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Manual Toothbrush 1 | Residual Protein Concentration | 39.7 ug/mL |
| Manual Toothbrush 2 | Residual Protein Concentration | 36.2 ug/mL |
| Manual Toothbrush + Interproximal Cleaning 1 | Residual Protein Concentration | 33.6 ug/mL |
| Manual Toothbrush + Interproximal Cleaning 2 | Residual Protein Concentration | 33.9 ug/mL |