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The primary objective of this clinical trial is to determine the oral hard and soft tissue tolerance of an investigational essential oil, non-alcohol, fluoride containing mouth rinse in children 6-11 years of age compared to brushing alone and a marketed comparator mouth rinse when used as directed over a four-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brush Only | Active Comparator | All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. |
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| Brush / Rinse (Jolly Rancher Prototype) | Experimental | All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (Jolly Rancher Prototype). |
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| Brush / Rinse (LISTERINE® Total Care Zero Alcohol) | Experimental | All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (LISTERINE® Total Care Zero Alcohol). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brush Only | Other | Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. Subjects will record their twice daily product usage on a subject diary. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues | Oral tissue tolerance will include the assessment of the number of participants with treatment-emergent adverse events (TEAEs) and those experiencing investigational product-related AEs throughout the observational study period of 28 days. In particular, oral examinations will include clinical evaluation of soft and hard tissues, such as buccal and sublingual mucosa, tongue, hard and soft palate, gingiva, uvula, oropharynx, teeth, and dental restorations, with findings recorded in the electronic data capture (EDC) system tissues tolerance to the treatments. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Parent perception questionnaire | Parent perception questionnaire will be summarized at Day 0 and Day 28 by investigational product, descriptively. No statistical comparisons will be performed. | Visit 1 (Day 0) and Visit 3 (Day 28) |
| Children self-perception questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye
Use of antibiotics, or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
Dental prophylaxis within four weeks prior to Screening/Baseline visit
Subjects who were previously screened and ineligible or were randomized to receive investigational product
Significant, unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator
Subjects who are related to those persons involved directly or indirectly with the conduct of this study
Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e- cigarette usage
Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant cosmetic restorations
Hasself-reported Type 1 or Type 2 diabetes oris taking insulin or another anti-diabetic medication
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
Is self-reported to be pregnant or planning to become pregnant during the study
Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
Participation in any clinical trial within 30 days of the Screening/Baseline visit
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
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| ID | Term |
|---|---|
| D014099 | Toothbrushing |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D009910 | Oral Hygiene |
| D011313 | Preventive Dentistry |
| D003813 | Dentistry |
| D000438 | Alcohols |
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| Brush / Rinse (Jolly Rancher Prototype) | Other | Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. After brushing for 1 timed minute, subjects will vigorously swish with 10mL (2 teaspoons) of rinse between their teeth for 1 minute and then spit out. Subjects will record their twice daily product usage on a subject diary. |
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| Brush / Rinse (LISTERINE® Total Care Zero Alcohol) | Other | Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. After brushing for 1 timed minute, subjects will vigorously swish with 10mL (2 teaspoons) of rinse between their teeth for 1 minute and then spit out. Subjects will record their twice daily product usage on a subject diary. |
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Children self-perception questionnaire will be summarized at Day 0 and Day 28 by investigational product, descriptively. No statistical comparisons will be performed. |
| Visit 1 (Day 0) and Visit 3 (Day 28) |
| D009930 |
| Organic Chemicals |