An interventional study of GumChucks and String floss in Gingivitis and Plaque, sponsored by University of California, Los Angeles. Completed. Open to participants aged 4 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
This study evaluates the interdental plaque removal efficacy, flossing speed, and reduction in gingival inflammation of a new flossing system (GumChucks®) compared to string floss, and to assess preference between the two flossing products in children, parents, and dentists.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
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Exclusion Criteria:
Device: String floss
Device: GumChucks
GumChucks® 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.
Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss
Interdental plaque score - after first use
Interdental plaque scores were recorded after the teeth were stained with plaque disclosing solutions (GUM® Red-Cote®) 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.
Time frame: 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 (GUM® Red-Cote®) 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.
Time frame: 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 1. = mild inflammation: slight change in color, little change in texture 2. = moderate inflammation: moderate erythema/edema, bleeding on pressure 3. = severe inflammation: severe erythema/edema, tendency to spontaneous bleeding, ulceration The gingival index score of each participant is the sum of all scores divided by the total numbers of buccal and lingual interdental papillae sites
Time frame: Baseline and 4 weeks
Flossing speed
The total time for a participant to floss all interdental contacts was measured in seconds.
Time frame: Day 1
Floss preferences by children, parents and dentists
Preferences of child participants, their parents and dentists toward the use of GumChucks® 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 GumChucks® usage on a model of the oral cavity.
Time frame: Day 1
No study locations are listed for this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles