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The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AirFloss + BreathRx | Experimental | Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day. |
|
| AirFloss + Listerine | Experimental | Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day. |
|
| Dental Floss | Experimental | Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day. |
|
| Manual Toothbrush | Active Comparator | Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirFloss + BreathRx | Device | Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation). | 28 days |
| Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pejmon Amini, DDS | Silverston Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silverstone Research Group | Las Vegas | Nevada | 89146 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AirFloss + Rinse1 | AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. |
| FG001 | AirFloss + Rinse2 | AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. |
| FG002 | String Floss | String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute |
| FG003 | Manual Toothbrush | Manual Toothbrush is used twice a day for 1 minute |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AirFloss + Rinse1 | AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. |
| BG001 | AirFloss + Rinse2 |
| 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 From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). | Posted | Least Squares Mean | Standard Error | units on a scale | 14 days |
|
Oral changes from baseline evaluated at Day 14 and 28
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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 | AirFloss + Rinse1 | AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingival Irritation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pejjmon Amini, DMD | Silverstone Research Group | 702-901-444 |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| 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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| AirFloss + Listerine | Device | Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily. |
|
| Dental Floss | Device | Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily. |
|
| Manual Toothbrush | Device | Manual Toothbrush used twice daily, 1 minute. |
|
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). |
| 14 days |
| Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). | 28 days |
| Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | 14 days |
| Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | 28 days |
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
| BG002 | String Floss | String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute |
| BG003 | Manual Toothbrush | Manual Toothbrush is used twice a day for 1 minute |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | String Floss | String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute |
| OG003 | Manual Toothbrush | Manual Toothbrush is used twice a day for 1 minute |
|
|
| Secondary | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation). | Posted | Least Squares Mean | Standard Error | units on a scale | 28 days |
|
|
|
| Secondary | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). | Posted | Least Squares Mean | Standard Error | units on a scale | 14 days |
|
|
|
| Secondary | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). | Posted | Least Squares Mean | Standard Error | units on a scale | 28 days |
|
|
|
| Secondary | Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | Posted | Least Squares Mean | Standard Error | units on a scale | 14 days |
|
|
|
| Secondary | Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). | Posted | Least Squares Mean | Standard Error | units on a scale | 28 days |
|
|
|
| 0 |
| 79 |
| 2 |
| 79 |
| EG001 | AirFloss + Rinse2 | AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. | 0 | 78 | 1 | 78 |
| EG002 | String Floss | String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute | 0 | 78 | 1 | 78 |
| EG003 | Manual Toothbrush | Manual Toothbrush is used twice a day for 1 minute | 0 | 51 | 0 | 51 |
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| D009057 |
| Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004864 |
| Equipment and Supplies |