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| ID | Type | Description | Link |
|---|---|---|---|
| GHRG-BOKA-STAIN-2025/01 | Other Identifier | Global Health Research Group H 8 Masjid Moth, GK-2, New Delhi, 110048, India |
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To determine whether brushing with a non-fluoride tooth whitening dentifrice containing nHAP and a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) for the overall tooth surfaces than brushing with a commercial fluoride toothpaste for a period of 2 weeks.
To determine whether brushing with a non-fluoride tooth whitening dentifrice containing nHAP and a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) for the overall tooth surfaces than brushing with a commercial fluoride toothpaste for a period of 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste | Experimental | Toothpaste with stain removing abilities. Toothpaste contains an abrasive system that provides increased stain removal capabilities. Product will be used by teh subject at home with a toothbrush. Instructions provided for daily use of the paste with the brush. Example brushing for two minutes per occasion. |
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| Paste Dentifrice | Placebo Comparator | Toothpaste with No stain removing abilities. The abrasive system used in teh placebo, though having cleaning properties, will not have teh ability to remove excessive stain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| toothpaste | Other | toothpaste with stain removing abilities |
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| Measure | Description | Time Frame |
|---|---|---|
| WHITENING | To determine whether brushing with a whitening dentifrice containing a high cleaning silica system produces a greater level of stain reduction as indicated by the Modified Lobene Stain Index (MLSI) Area x Intensity score for the overall tooth surfaces than brushing with a commercial fluoride non-whitening dentifrice as a negative control for 2 weeks. | 2 WEEKS |
| TOOTH COLOR | TOOTH WHITENING AND ORAL OIFT TISSUE INTEGRITY To determine the oral soft tissue (OST) tolerance of the dentifrices. To compare the change from baseline in stain levels as represented by the MLSI scores for overall, gingival, interproximal and body areas of the facial and lingual surfaces for each dentifrice after 2 weeks of product use. | 2 WEEKS |
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Inclusion Criteria:
Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
2) Age Aged at least 18 years.
3) Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions.
4) General Health Good general health with no clinically significant and relevant abnormalities of medical history or dental examination in the opinion of the investigator or dental assessor.
5) Dental Details
Exclusion Criteria:
Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
2) Breast-feeding Women who are breast-feeding.
3) Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
4) Clinical Study/Experimental Medication
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| Name | Affiliation | Role |
|---|---|---|
| ASHISH KAKAR, BDS | GHRG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Health Research Group | New Delhi | National Capital Territory of Delhi | 110048 | India |
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| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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