N/A
Completed N=170
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Source: ClinicalTrials.gov NCT01250769 ↗Enrolled (actual)
170
Serious AEs
0.6%
Results posted
Sep 2012
Primary outcomePrimary: Residual Protein Concentration — 33.5; 28; 20.4; 20.2 ug/mL
Summary
This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Protein Concentration |
39.7; 36.2; 33.6; 33.9 | — |
| SECONDARY Residual Protein Concentration |
39.7; 36.2; 33.6; 33.9 | — |
| SECONDARY Modified Gingival Index |
1.35; 1.44; 1.23; 1.41 | — |
| SECONDARY Gingival Bleeding Index |
0.3; 0.26; 0.16; 0.2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01250769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.