Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare three different oral hygiene regimens on changes in gum tissue appearance, gum bleeding, and plaque scores.
The goal of this clinical trial was to compare the effect of different battery powered water in and adult population with mild to moderate gingivitis. The main questions it aims to answer are:
Researchers will compare the two groups using a water flosser (experimental) to see how it compares to traditional brushing and flossing (control).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual toothbrush and water flosser with standard jet tip | Experimental | Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening |
|
| Manual toothbrush and water flosser with targeted jet tip | Experimental | Brush with a standard ADA manual toothbrush twice daily followed by water flossing once in the evening |
|
| Manual toothbrush and dental floss | Active Comparator | Brush with a standard ADA manual toothbrush twice daily followed by dental flossing once in the evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waterpik Water Flosser | Device | A pulsating water flosser and jet tip designed to clean between the teeth and below the gingival margin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing | Bleeding recorded on 6 sites per tooth within 30 seconds of instrumentation. 0 = no bleeding, 1= bleeding. Bleeding determined by number of sites bleeding divided by total number of sites = percent bleeding | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Modified gingival index | Visual assessment of the gingival tissue. 0 = absence of inflammation, 1 = mild inflammation (slight change in color, little change in texture of any porting of but not the entire marginal or papillary gingival area), 3 = moderate inflammation (glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival area), 4 = severe inflammation (marked redness, edema and/or hypertrophy of the marginal or papillary gingival area, spontaneous bleeding, congestion, or ulceration. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah Mancinelli Lyle | Water Pik, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum Research Center Ltd. | Mississauga | Ontario | L5N 6J2 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Oral-B Water Flosser | Device | A water flosser and specialized tip that delivers water with microbubbles of air |
|
|
| Waxed Dental Floss | Device | Nylon string used to clean between the teeth manually |
|
| 4 weeks |
| Rustogi Modification of Navy Plaque Index | Plaque is assessed for each tooth area (divided into 9 sections labeled A through I) and scored using the following scale: 0 = absent, and 1 = present. Facial and lingual surfaces of all gradable teeth are scored and a mean plaque index is calculated for each subject at each examination. Subjects' scores were calculated for whole mouth (A through I), along the gingival margin (A through C), and at the proximal (approximal) areas (D and F). | 4 weeks |
| D009057 |
| Stomatognathic Diseases |