Randomized Trial of a Gum Health Formulation

June 20, 2017 updated by: Glo Science, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02142
        • The Forsyth Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gingival health formulation in accelerating device
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.
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 Names:
  • ECO Balance
  • GLO Science accelerating device
Other: OTC fluoride toothpaste
OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
Other Names:
  • GLO Science Antioxidant Toothpaste
Experimental: Gingival health formulation on a toothbrush
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.
Other: OTC fluoride toothpaste
OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
Other Names:
  • GLO Science Antioxidant Toothpaste
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 Names:
  • ECO Balance
Active Comparator: Control group (Split mouth design)
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.
Other: OTC fluoride toothpaste
OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
Other Names:
  • GLO Science Antioxidant Toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in bleeding on probing
Time Frame: Baseline to 42 days
Baseline to 42 days
Differences in Gingival Index
Time Frame: Baseline to 42 days
Baseline to 42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Plaque Index
Time Frame: Baseline to 42 days
Baseline to 42 days
Difference in mean probing depth
Time Frame: Baseline to 42 days
Baseline to 42 days
Change in oral malodor
Time Frame: Baseline to 42 days
Chromatographic measure of volatile sulfur compounds (hydrogen sulfide, dimethyl sulfide, methyl mercaptan)
Baseline to 42 days
Change in tooth whitening
Time Frame: Baseline to 42 days
Baseline to 42 days
Change in sub-gingival bacterial profile
Time Frame: Baseline to 28 days
DNA-DNA Hybridization Checkerboard; Measurement of bacterial load
Baseline to 28 days
Change in inflammatory cytokines
Time Frame: Baseline to 28 days
Measurement of IL-1B, TNF-a, IL-6, IL-8 & MCP-1 volume from gingival crevicular fluid samples
Baseline to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glo Science, Inc.

Collaborators

The Forsyth Institute

Investigators

  • Principal Investigator: Hatice Hasturk, DDS, PhD, The Forsyth Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLO-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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