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Completed

NCT Number: NCT03196648

Randomized Trial of a Gum Health Formulation

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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Key information

Conditions

Periodontal Diseases Gingival Diseases Gingivitis Halitosis Infections Inflammation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontitis Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: ECO Balance, GLO Science accelerating device

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.

Other names: ECO Balance

OTC fluoride toothpaste

Other

OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.

Other names: GLO Science Antioxidant Toothpaste

Primary outcomes

  1. Differences in bleeding on probing

    Time frame: Baseline to 42 days

  2. Differences in Gingival Index

    Time frame: Baseline to 42 days

Secondary outcomes

  1. Difference in Plaque Index

    Time frame: Baseline to 42 days

  2. Difference in mean probing depth

    Time frame: Baseline to 42 days

  3. Change in oral malodor

    Time frame: Baseline to 42 days

    Chromatographic measure of volatile sulfur compounds (hydrogen sulfide, dimethyl sulfide, methyl mercaptan)

  4. Change in tooth whitening

    Time frame: Baseline to 42 days

  5. Change in sub-gingival bacterial profile

    Time frame: Baseline to 28 days

    DNA-DNA Hybridization Checkerboard; Measurement of bacterial load

  6. 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

Sponsors and collaborators

Lead sponsor

Glo Science, Inc.

Industry

Collaborators

  • The Forsyth Institute

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2017
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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