Randomized Trial of a Gum Health Formulation
Public ClinicalTrials.gov record NCT03196648. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03196648
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 39 participants
Conditions and interventions
Conditions
Interventions
- Gingival health formulation in an accelerating device Other
- Gingival health formulation on a toothbrush Other
- OTC fluoride toothpaste Other
Other
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2015
- Primary completion
- Nov 29, 2016
- Completion
- Nov 29, 2016
- Last update posted
- Jun 22, 2017
2015 – 2016
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Forsyth Institute | Cambridge | Massachusetts | 02142 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03196648, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03196648 live on ClinicalTrials.gov.