Dental Plaque, Dental Plaque Induced Gingivitis
Conditions
Brief summary
It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.
Detailed description
The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made. Study design: randomised, single blinded, parallel. After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0. The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations. At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush. The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study. On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.
Interventions
DEVICEOral B Healthy Clean Manual Toothbrush
Manual Toothbrush
DEVICEBURST Sonic Oral Care
Electric sonic toothbrush
DEVICEPhilipps Sonicare DiamondClean 300 Series
Electric pulsating toothbrush
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Good overall health 2. At least 20 teeth present, not including 3rd Molars 3. Non-smoker
Exclusion criteria
1. Poor manual dexterity or mentally handicap; 2. Presence of removable intra-oral prosthesis 3. Current orthodontic therapy 4. Severe Periodontal condition or caries teeth in need of immediate attention 5. Pregnant women 6. Subjects that use medications that may effect oral health 7. No Systemic diseases/conditions such as diabetes mellitus, heart disease. 8. Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | Baseline, 1 month | plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3). |
| Gingival Index | Baseline, 1 month | gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulsating Toothbrush Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush | 28 |
| Sonic Toothbrush Patients were asked to use a sonic toothbrush for 30 days
BURST Sonic Oral Care: Electric sonic toothbrush | 30 |
| Manual Toothbrush Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush | 24 |
| Total | 82 |
Baseline characteristics
| Characteristic | Total | Sonic Toothbrush | Manual Toothbrush | Pulsating Toothbrush |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 82 Participants | 30 Participants | 24 Participants | 28 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 82 participants | 30 participants | 24 participants | 28 participants |
| Sex: Female, Male Female | 49 Participants | 19 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Male | 33 Participants | 11 Participants | 10 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 30 | 0 / 24 |
| other Total, other adverse events | 0 / 28 | 0 / 30 | 0 / 24 |
| serious Total, serious adverse events | 0 / 28 | 0 / 30 | 0 / 24 |
Outcome results
Primary
Gingival Index
gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Time frame: Baseline, 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsating Toothbrush | Gingival Index | Baseline | 0.42 units on a scale | Standard Deviation 0.41 |
| Pulsating Toothbrush | Gingival Index | 1 Month | 0.22 units on a scale | Standard Deviation 0.16 |
| Sonic Toothbrush | Gingival Index | Baseline | 0.35 units on a scale | Standard Deviation 0.41 |
| Sonic Toothbrush | Gingival Index | 1 Month | 0.16 units on a scale | Standard Deviation 0.16 |
| Manual Toothbrush | Gingival Index | Baseline | 0.36 units on a scale | Standard Deviation 0.39 |
| Manual Toothbrush | Gingival Index | 1 Month | 0.14 units on a scale | Standard Deviation 0.13 |
Comparison: Compare groups with respect to Gingival scores at 30 daysp-value: 0.2161ANOVA
Primary
Plaque Index
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Time frame: Baseline, 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pulsating Toothbrush | Plaque Index | 1 Month | 1.11 units on a scale | Standard Deviation 0.27 |
| Pulsating Toothbrush | Plaque Index | Baseline | 1.07 units on a scale | Standard Deviation 0.24 |
| Sonic Toothbrush | Plaque Index | 1 Month | 1.27 units on a scale | Standard Deviation 0.4 |
| Sonic Toothbrush | Plaque Index | Baseline | 1.19 units on a scale | Standard Deviation 0.25 |
| Manual Toothbrush | Plaque Index | Baseline | 1.31 units on a scale | Standard Deviation 0.27 |
| Manual Toothbrush | Plaque Index | 1 Month | 1.20 units on a scale | Standard Deviation 0.24 |
Comparison: Compare groups with respect to plaque level after 30 daysp-value: 0.1561ANOVA