Randomized Trial of a Gum Health Formulation

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196648
• Other study ID #: GLO-002
• Status: Completed
• Phase: N/A
• First received: June 19, 2017
• Last updated: June 20, 2017
• Start date: May 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: June 2017
• Source: Glo Science, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Willing and able to read, understand and sign an Informed Consent Form

• Good general health as evidenced by the medical history

• Between 18 and 55 years of age

• Male or female

• Minimum of 20 teeth, excluding crowns and third molar teeth

• Mean whole mouth Gingival Index >/=2.0 at baseline; sites with </=7mm pocket depth

• Willing to abstain from all oral hygiene procedures 12-18 hours prior to clinical visits

• Willing to abstain from eating and drinking for 2 hours prior to clinical visits, only drinking water is allowed

• Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration

• Able to understand and follow study directions

Exclusion Criteria:

• Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta-blockers

• Diagnosed with diabetes

• Presence of orthodontic appliances

• Presence of large restorations, crown or veneer at the anterior of both upper and lower teeth (including premolar teeth)

• A soft or hard tissue tumor of the oral cavity

• Carious lesions requiring immediate treatment

• Patients with severe internal (tetracycline stains) and external discoloration (fluorosis)

• Patients with severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis, or generalized gingival recession >2mm as evidenced by clinical oral exam

• Pregnant or breast-feeding women

• Allergy to home bleaching products such as hydrogen peroxide and carbide peroxide

• Use of antibiotics within 3 months of enrollment

• History of drug use that is associated with gum overgrowth (i.e., Dilantin, nifedipine, etc.)

• Chronic use of medication such as steroids, anti-coagulant medications, immunosuppressant medication or any other medications or medical conditions that in the opinion of the Investigator would interfere with the evaluation or confound interpretation of the study results. Use of low dose of ASA (<325mg) is permitted.

• Medical condition which requires pre-medication prior to dental visits/procedures

• Current smoking and former smoking within one year of enrollment

Related Conditions & MeSH terms

• Gingival Diseases
• Gingivitis
• Halitosis
• Periodontal Diseases
• Periodontitis

Intervention

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
• 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.
• OTC fluoride toothpaste
OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.

Locations

Country	Name	City	State
United States	The Forsyth Institute	Cambridge	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Glo Science, Inc.	The Forsyth Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in bleeding on probing		Baseline to 42 days
Primary	Differences in Gingival Index		Baseline to 42 days
Secondary	Difference in Plaque Index		Baseline to 42 days
Secondary	Difference in mean probing depth		Baseline to 42 days
Secondary	Change in oral malodor	Chromatographic measure of volatile sulfur compounds (hydrogen sulfide, dimethyl sulfide, methyl mercaptan)	Baseline to 42 days
Secondary	Change in tooth whitening		Baseline to 42 days
Secondary	Change in sub-gingival bacterial profile	DNA-DNA Hybridization Checkerboard; Measurement of bacterial load	Baseline to 28 days
Secondary	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