Soft Tissue Injuries
Conditions
Brief summary
Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings
Detailed description
This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.
Interventions
DEVICEWater Flosser
Power interdental cleaner
DEVICEString Floss
Mechanical interdental cleaner
DEVICEManual Toothbrush
ADA standard soft bristle toothbrush
Sponsors
Water Pik, Inc.
All Sum Research Center Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Intervention model description
This is a examiner-masked, 3-treatment, randomized clinical trial comparing the safety of different oral hygiene regimens.
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Written consent prior to participation * Good general health and non smoker * Have scorable Ramfjord's teeth
Exclusion criteria
* Probing depth \>4mm on Ramfjord's teeth * Moderate to severe gingivitis * Advanced periodontitis * Medications that impact soft tissue.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Levels | 6 weeks | Measurement from the junction Epithelium to the cemento enamel junction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing pocket depth | 6 weeks | Measurement from the junction Epithelium to the free gingival margin |
Outcome results
None listed