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| Name | Class |
|---|---|
| The Forsyth Institute | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without flossing (split mouth design for control group).
This is a 60-day randomized single blinded parallel group study. After 42 days, all use of interventional products were discontinued, and the participants returned to the clinical center at day 60 for final measurements. The primary outcomes assessed in this study were the differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 & 60 days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque amount.
It is hypothesized that participants using the gingival health product with the GLO Device will experience greater reductions in GI & BOP measurements than the control group, as well as participants using the gingival health product on a toothbrush alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gingival health formulation in accelerating device | Experimental | The interventional gingival health formulation is applied to the participant's mouth by means of an intra-oral accelerating device for a single eight-minute application, daily. Participants were instructed to brush their teeth with an OTC toothpaste twice daily, morning and night. |
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| Gingival health formulation on a toothbrush | Experimental | The interventional gingival health formulation is applied to the participant's mouth by means of a toothbrush and OTC toothpaste, together with the formulation in equal amounts, for two-minute applications twice daily, morning and night. |
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| Control group (Split mouth design) | Active Comparator | The control group did not receive the interventional gingival health formulation. Participants were instructed to brush their teeth with a toothbrush and OTC toothpaste twice daily, morning and night. In addition, participants were instructed to floss only half of their mouth daily, having the non-flossed half serve as an untreated comparative control of toothbrushing alone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gingival health formulation in an accelerating device | Other | The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used with the GLO Science Device |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in bleeding on probing | Baseline to 42 days | |
| Differences in Gingival Index | Baseline to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Plaque Index | Baseline to 42 days | |
| Difference in mean probing depth | Baseline to 42 days | |
| Change in oral malodor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hatice Hasturk, DDS, PhD | The Forsyth Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Forsyth Institute | Cambridge | Massachusetts | 02142 | United States |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D005891 | Gingivitis |
| D010518 | Periodontitis |
| D006209 | Halitosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |
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| Gingival health formulation on a toothbrush | Other | The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used on a toothbrush together with toothpaste. |
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| OTC fluoride toothpaste | Other | OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate. |
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Chromatographic measure of volatile sulfur compounds (hydrogen sulfide, dimethyl sulfide, methyl mercaptan) |
| Baseline to 42 days |
| Change in tooth whitening | Baseline to 42 days |
| Change in sub-gingival bacterial profile | DNA-DNA Hybridization Checkerboard; Measurement of bacterial load | Baseline to 28 days |
| Change in inflammatory cytokines | Measurement of IL-1B, TNF-a, IL-6, IL-8 & MCP-1 volume from gingival crevicular fluid samples | Baseline to 28 days |
| D012817 |
| Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |