NCT03196648

Randomized Trial of a Gum Health Formulation

A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Glo Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Periodontal Diseases
• Gingivitis
• Periodontitis
• Halitosis

Interventions

Type	Name	Description
OTHER	Gingival health formulation in an accelerating device	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
OTHER	Gingival health formulation on a toothbrush	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.
OTHER	OTC fluoride toothpaste	OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2017-06-23
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States