Randomized Trial of a Gum Health Formulation

NCT03196648 | Completed

• 1 other identifier: GLO-002
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingivitis; Periodontal disease; Inflammation; Teeth whitening; Breath freshening; Periodontal pathogens; Bleeding on probing

Outcome Measures

Primary Outcomes (2)

• Differences in bleeding on probing

  Baseline to 42 days

• Differences in Gingival Index

  Baseline to 42 days

Secondary Outcomes (6)

• Difference in Plaque Index

  Baseline to 42 days

• Difference in mean probing depth

  Baseline to 42 days

• Change in oral malodor

  Baseline to 42 days

• Change in tooth whitening

  Baseline to 42 days

• Change in sub-gingival bacterial profile

  Baseline to 28 days

Study Arms (3)

Gingival health formulation in accelerating device

EXPERIMENTAL

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; Other: OTC fluoride toothpaste

Gingival health formulation on a toothbrush

EXPERIMENTAL

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: Gingival health formulation on a toothbrush; Other: OTC fluoride toothpaste

Control group (Split mouth design)

ACTIVE COMPARATOR

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

Interventions

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

Also known as: ECO Balance, GLO Science accelerating device

Gingival health formulation in 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.

Also known as: ECO Balance

Gingival health formulation on a toothbrush

OTC fluoride toothpaste OTHER

OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.

Also known as: GLO Science Antioxidant Toothpaste

Control group (Split mouth design); Gingival health formulation in accelerating device; Gingival health formulation on a toothbrush

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glo Science, Inc.: lead
• The Forsyth Institute: collaborator

Study Sites (1)

The Forsyth Institute

Cambridge, Massachusetts, 02142, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Gingivitis; Periodontitis; Halitosis; Inflammation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Hatice Hasturk, DDS, PhD

  The Forsyth Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 23, 2017
• Study Start: May 1, 2015
• Primary Completion: November 30, 2016
• Study Completion: November 30, 2016
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)