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The objective of this clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brushing | Placebo Comparator | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator). |
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| Brushing and Flossing | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site. |
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| Brushing and Rinsing A | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds. |
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| Brushing and Rinsing B | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mouthwash | Drug | Antiplaque/Antigingivitis Mouthwash |
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| Measure | Description | Time Frame |
|---|---|---|
| Interproximal mean Modified Gingival Index (MGI) | MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Interproximal MGI includes the mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Whole Mouth mean Modified Gingival Index (MGI) | MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Whole Mouth MGI includes all six sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Milleman, DDS, MPA | Salus Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009067 | Mouthwashes |
| D003742 | Dental Devices, Home Care |
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
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| Brushing and Rinsing C | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds. |
|
| Floss | Device | Dental Floss |
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| Toothbrush | Device | Soft bristled, manual toothbrush |
|
| Toothpaste | Drug | Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste |
|
| 1, 4, and 12 weeks |
| Interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI) | Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows: 0=No plaque
Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per above. | 1, 4, and 12 weeks |
| Whole Mouth mean Turesky Modification of the Quigley-Hein Plaque Index (TPI) | Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows: 0=No plaque
Whole Mouth mean includes all six sites. Higher scores indicate a worse outcome, per above. | 1, 4, and 12 weeks |
| Interproximal mean Expanded Bleeding Index (EBI) | EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome, per below. 0 = no bleeding after 30 seconds
| 1, 4, and 12 weeks |
| Whole Mouth Expanded Bleeding Index (EBI) | EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome, per below. 0 = no bleeding after 30 seconds
| 1, 4, and 12 weeks |
| Interproximal mean Bleeding on Probing (BOP) | Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome. | 12 weeks |
| Whole Mouth mean Bleeding on Probing (BOP) | Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome. | 12 weeks |
| Interproximal mean Probing Depth (PD) | Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition. | 12 weeks |
| Whole Mouth mean Probing Depth (PD) | Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition. | 12 weeks |
| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D003748 | Dental Equipment |
| D003813 | Dentistry |
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D004864 | Equipment and Supplies |
| D003802 | Dentifrices |