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A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.
NA trial testing Oral B Healthy Clean Manual Toothbrush in Dental Plaque Induced Gingivitis in 90 participants. Completed in 30 December 2018.
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 90 |
| Start date | 2 January 2018 |
| Primary completion | 1 November 2018 |
| Estimated completion | 30 December 2018 |
| Sites | 1 location across United States |
University of California, Los Angeles
18 and older, any sex, with Dental Plaque Induced Gingivitis or Dental Plaque. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
| Group | Value | 95% CI |
|---|---|---|
| Pulsating Toothbrush | 1.07 | ± 0.24 |
| Sonic Toothbrush | 1.19 | ± 0.25 |
| Manual Toothbrush | 1.31 | ± 0.27 |
| Group | Value | 95% CI |
|---|---|---|
| Pulsating Toothbrush | 1.11 | ± 0.27 |
| Sonic Toothbrush | 1.27 | ± 0.40 |
| Manual Toothbrush | 1.20 | ± 0.24 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Manual Toothbrush | 0.42 | ± 0.41 |
| Sonic Toothbrush | 0.35 | ± 0.41 |
| Pulsating Toothbrush | 0.36 | ± 0.39 |
| Group | Value | 95% CI |
|---|---|---|
| Manual Toothbrush | 0.22 | ± 0.16 |
| Sonic Toothbrush | 0.16 | ± 0.16 |
| Pulsating Toothbrush | 0.14 | ± 0.13 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing