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| Name | Class |
|---|---|
| University of Taubate | OTHER |
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The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Listerine Zero Mouthwash (without alcohol) | Active Comparator | Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Zero Mouthwash (without alcohol) for 30 seconds. |
|
| Listerine Antiseptic Mouthwash (with alcohol) | Active Comparator | Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Antiseptic Mouthwash (with alcohol) for 30 seconds. |
|
| Brush only | No Intervention | Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Listerine Zero Mouthwash (without alcohol) | Other | 20 ml of rinse for 30 seconds, twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Modified Gingival Index (MGI) at 6 Months | Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Modified Gingival Index (MGI) at 1 Month | Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation. | 1 Month |
| Mean Modified Gingival Index (MGI) at 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Cortelli, Ph. D | Universidade de Taubate | Principal Investigator |
| Sheila Cortelli, Ph.D | Universidade de Taubate | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Taubate | Taubaté | São Paulo | 12020-270 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29321067 | Derived | Lynch MC, Cortelli SC, McGuire JA, Zhang J, Ricci-Nittel D, Mordas CJ, Aquino DR, Cortelli JR. The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study. BMC Oral Health. 2018 Jan 10;18(1):6. doi: 10.1186/s12903-017-0454-6. |
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| Listerine Antiseptic Mouthwash (with alcohol) | Other | 20 ml of rinse for 30 seconds, twice a day |
|
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation. |
| 3 Months |
| Mean Gingival Bleeding Index (BI) at 1 Month | Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding. | 1 Month |
| Mean Gingival Bleeding Index (BI) at 3 Months | Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding. | 3 Months |
| Mean Gingival Bleeding Index (BI) at 6 Months | Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding. | 6 Months |
| Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month | Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface. | 1 Month |
| Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months | Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface. | 3 Months |
| Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months | Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface. | 6 Months |
| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| D005891 | Gingivitis |
| D006470 | Hemorrhage |
| D005884 | Gingival Hemorrhage |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D006472 | Oral Hemorrhage |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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