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To evaluate and compare plaque removal efficacy and safety of a novel dentifrice formulation immediately after the first supervised use and following one week of twice, daily use at home.
Study participants brushed their teeth for one minute, two times daily, for seven days.
Participants who met study entry criteria were randomized to either the test (Protegeraâ„¢) or control (Crestâ„¢ Cavity Protection) toothpaste, and each were given the same straight, soft bristled toothbrush to use throughout the study.
On Day 1, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
On Day 7, participants were given an oral exam, and a pre-brushing plaque score was recorded. Participants then brushed their teeth for one minute under supervision, and a post-brushing plaque score was recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Protegeraâ„¢ toothpaste (NaF), brushing twice daily for one minute |
|
| Control | Active Comparator | Crestâ„¢ Cavity Protection toothpaste (NaF), brushing twice daily for one minute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protegeraâ„¢ toothpaste (NaF) | Drug | Plaque Reduction |
| |
| Crestâ„¢ Cavity Protection toothpaste (NaF) |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Dental Plaque | Plaque measured on a scale of 0 to 5; 0 = No plaque; 5 = 2/3rd or more of tooth covered with plaque | Day 1 and Day 7 of manual brushing |
| Changes in oral soft or hard tissues | Examination of the oral cavity to determine any changes in color, soft tissue abrasion, texture or other irregularities | Day 1 and Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery L Milleman, DDS, MPA | Salus Research, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6980082 | Result | Lobene RR, Soparkar PM, Newman MB. Use of dental floss. Effect on plaque and gingivitis. Clin Prev Dent. 1982 Jan-Feb;4(1):5-8. No abstract available. | |
| 5264376 | Result | Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available. |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomized, single-center, examiner-blinded, parallel design clinical trial.
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The investigators performing plaque scoring, study coordinators entering plaque scores and handling data, and the statistician performing the data analysis were all blinded to the treatment regimen
| Drug |
Plaque Reduction |
|
| 14489483 | Result | QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available. |