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The aim of this study is to evaluate the efficacy of a new interdental cleaning device (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can promote the establishment of a hygienic routine of cleaning interproximal spaces.
The Soft-Picks Advanced has a new curved design allowing a user to easily access to difficult interdental sites, such as spaces between premolars and molars. This study is a single center with parallel design, single blinded, which will randomize eligible subjects into two treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soft-Picks Advanced | Experimental | Device: Curved Soft-Picks |
|
| Floss | Active Comparator | Device: Waxed tape floss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft-Picks Advanced | Device | Soft-picks Advanced will be used once a day to clean interdental sites at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days | Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface). Change = (14 days Score - Baseline Score) | Baseline and 14 days |
| Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days | Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface) Change = (28 days Score - Baseline Score) | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Performance (Easy to Use) of an Assigned Product | Subjects record product performance and experience on a diary. Scale of Easy to Use was scored from 1 to 5 (1= Not easy; 5= Very easy). | 28 days |
| Change in Gingivitis by UNC Modified Gingival Index at 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Moretti, DDS, MS | Clinical Associate Professor and Graduate Program Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology UNC School of Dentistry | Chapel Hill | North Carolina | 27599-7450 | United States |
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All subjects received professional prophylaxis and assigned manual toothbrush and dentifrice. Group was assigned 3 weeks or more after professional prophylaxis.
This study enrolled subjects with signs and symptoms of gingivitis and no or little experience with inter-proximal cleaning device in the single center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Floss | Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home. |
| FG001 | Soft-Picks Advanced | Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Soft-Picks Advanced | Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home. |
| BG001 | Floss | Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days | Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface). Change = (14 days Score - Baseline Score) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 14 days |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Soft-Picks Advanced | Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager of R&D | Sunstar Americas, Inc. | 8477944276 | akane.takemura@us.sunstar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2016 | Oct 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D003742 | Dental Devices, Home Care |
| ID | Term |
|---|---|
| D003748 | Dental Equipment |
| D003813 | Dentistry |
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
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| Floss | Device | Floss will be used once a day to clean interdental sites at home. |
|
Gingiva shall be assessed at 6 sites per tooth: distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual and mesiolingual surfaces (Scale is 0-3: 0 =Normal gingiva (pink, firm, stippled), 3 =Severe inflammation: marked redness and edema, ulceration, tendency to spontaneous bleeding). Change = (28 days Score - Baseline Score) |
| Baseline and 28 days |
| Change in Gingivitis by Bleeding on Probing at 28 Days | Presence or absence of bleeding within 10 seconds after probing shall be scored at 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces. The number of sites where bleeding is recorded is divided by the total number of available sites and multiplied by 100 to express the bleeding on probing as a percentage. Change = (28 days percentage - Baseline percentage) | Baseline and 28 days |
| Change in Gingivitis by Probing Pocket Depth at 28 Days | 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement) | Baseline and 28 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Device: Waxed tape floss
Floss: Floss will be used once a day to clean interdental sites at home.
|
|
| Primary | Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days | Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface) Change = (28 days Score - Baseline Score) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 28 days |
|
|
|
| Secondary | Performance (Easy to Use) of an Assigned Product | Subjects record product performance and experience on a diary. Scale of Easy to Use was scored from 1 to 5 (1= Not easy; 5= Very easy). | Posted | Mean | Standard Deviation | score on a scale | 28 days |
|
|
|
| Secondary | Change in Gingivitis by UNC Modified Gingival Index at 28 Days | Gingiva shall be assessed at 6 sites per tooth: distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual and mesiolingual surfaces (Scale is 0-3: 0 =Normal gingiva (pink, firm, stippled), 3 =Severe inflammation: marked redness and edema, ulceration, tendency to spontaneous bleeding). Change = (28 days Score - Baseline Score) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 28 days |
|
|
|
| Secondary | Change in Gingivitis by Bleeding on Probing at 28 Days | Presence or absence of bleeding within 10 seconds after probing shall be scored at 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces. The number of sites where bleeding is recorded is divided by the total number of available sites and multiplied by 100 to express the bleeding on probing as a percentage. Change = (28 days percentage - Baseline percentage) | Posted | Mean | Standard Deviation | percentage of Bleeding on Probing | Baseline and 28 days |
|
|
|
| Secondary | Change in Gingivitis by Probing Pocket Depth at 28 Days | 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement) | Posted | Mean | Standard Deviation | mm | Baseline and 28 days |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 1 |
| 26 |
| EG001 | Floss | Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home. | 0 | 24 | 0 | 24 | 5 | 24 |
| Ingrown toenail | Infections and infestations | Non-systematic Assessment |
|
| Finger dislocating | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Torn hamstring | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. PI shall delay publications for up to 60 days to allow sufficient time to resolve any questions or seek patent protection.
| D009057 |
| Stomatognathic Diseases |
| D004864 |
| Equipment and Supplies |