Effectiveness of the GumChucks® Flossing System Compared to String Floss for Interdental Plaque Removal in Children

Study Overview
=================
Brief Summary
-----------------
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.

Conditions
-----------------
Gingivitis, Plaque

Intervention / Treatment
-----------------
* Device: GumChucks
* Device: String floss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy children aged 4-15 years, who were not on any type of medication presence of at least 4 posterior interdental contacts ability to follow verbal and/or written instruction availability for a 4-week study period one parent or legal guardian of each included child participant. Exclusion Criteria: had antibiotics within the last 6 months are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: String floss<br> | Device: String floss<br>* Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss<br>|
| Experimental: Gumchucks floss<br> | Device: GumChucks<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 = mild inflammation: slight change in color, little change in texture = moderate inflammation: moderate erythema/edema, bleeding on pressure = 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 | Baseline and 4 weeks | 
| Flossing speed | The total time for a participant to floss all interdental contacts was measured in seconds. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interdental plaque, Flossing aid, Children, Gingival inflammation