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This study evaluates the interdental plaque removal efficacy, flossing speed, and reduction in gingival inflammation of a new flossing system (GumChucksĀ®) compared to string floss, and to assess preference between the two flossing products in children, parents, and dentists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| String floss | Active Comparator |
| |
| Gumchucks floss | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GumChucks | Device | GumChucksĀ® is an innovative flossing system resembling mini nunchucks. The two-handle design eliminates the need to wrap the floss around fingers, and a proper flossing technique is facilitated by the nature of its curved shaped. |
| Measure | Description | Time Frame |
|---|---|---|
| Interdental plaque score - after first use | Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUMĀ® Red-CoteĀ®) for 30 seconds followed by a water rinse. Interdental plaque was scored either presence or absence at 4 sites of each tooth (mesio-buccal, disto-buccal, mesio-lingual, and disto-lingual). Score of 0 = If disclosing solution shows no visible plaque at the site Score of 1 = if disclosing solution shows the presence of any plaque between interproximal contact and the respective line angle of that site. The total interdental plaque score for each participant is the sum of all sites stained positive with disclosing solution. | Baseline and Day 1 |
| Interdental plaque score - after 4 weeks of usage | Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUMĀ® Red-CoteĀ®) for 30 seconds followed by a water rinse. Interdental plaque was scored either presence or absence at 4 sites of each tooth (mesio-buccal, disto-buccal, mesio-lingual, and disto-lingual). Score of 0 = If disclosing solution shows no visible plaque at the site Score of 1 = if disclosing solution shows the presence of any plaque between interproximal contact and the respective line angle of that site. | Baseline and 4 weeks |
| Gingival index - after 4 weeks of usage | Gingival inflammation was assessed using the gingival index where the scores were taken of the buccal and lingual margins of the interdental papillae adjacent to interdental contacts with the following scoring system: 0 = absence of inflammation
| Baseline and 4 weeks |
| Flossing speed |
| Measure | Description | Time Frame |
|---|---|---|
| Floss preferences by children, parents and dentists | Preferences of child participants, their parents and dentists toward the use of GumChucksĀ® in comparison to string floss was measured by a 5-point Likert scale questionnaire. Child participants and their parents completed questionnaires after using both flossing products, while dentists completed questionnaires after viewing the video and/or live demonstration of GumChucksĀ® usage on a model of the oral cavity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 9, 2021 | |
| Reset | Apr 2, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 9, 2021 | Apr 2, 2021 |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| String floss | Device | Traditional string floss used in this study was Oral-B GlideĀ® Pro-Health Original Floss |
|
The total time for a participant to floss all interdental contacts was measured in seconds.
| Day 1 |
| Day 1 |
| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |