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Randomized Trial of a Gum Health Formulation

Primary Purpose

Periodontal Diseases, Gingivitis, Periodontitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gingival health formulation in an accelerating device
Gingival health formulation on a toothbrush
OTC fluoride toothpaste
Sponsored by
Glo Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Gingivitis, Periodontal disease, Inflammation, Teeth whitening, Breath freshening, Periodontal pathogens, Bleeding on probing

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Forsyth Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Gingival health formulation in accelerating device

Gingival health formulation on a toothbrush

Control group (Split mouth design)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Differences in bleeding on probing
Differences in Gingival Index

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2017
Last Updated
June 20, 2017
Sponsor
Glo Science, Inc.
Collaborators
The Forsyth Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03196648
Brief Title
Randomized Trial of a Gum Health Formulation
Official Title
A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glo Science, Inc.
Collaborators
The Forsyth Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Gingivitis, Periodontitis, Halitosis
Keywords
Gingivitis, Periodontal disease, Inflammation, Teeth whitening, Breath freshening, Periodontal pathogens, Bleeding on probing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gingival health formulation in accelerating device
Arm Type
Experimental
Arm Description
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.
Arm Title
Gingival health formulation on a toothbrush
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (Split mouth design)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gingival health formulation in an accelerating device
Other Intervention Name(s)
ECO Balance, GLO Science accelerating device
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Gingival health formulation on a toothbrush
Other Intervention Name(s)
ECO Balance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
OTC fluoride toothpaste
Other Intervention Name(s)
GLO Science Antioxidant Toothpaste
Intervention Description
OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
Primary Outcome Measure Information:
Title
Differences in bleeding on probing
Time Frame
Baseline to 42 days
Title
Differences in Gingival Index
Time Frame
Baseline to 42 days
Secondary Outcome Measure Information:
Title
Difference in Plaque Index
Time Frame
Baseline to 42 days
Title
Difference in mean probing depth
Time Frame
Baseline to 42 days
Title
Change in oral malodor
Description
Chromatographic measure of volatile sulfur compounds (hydrogen sulfide, dimethyl sulfide, methyl mercaptan)
Time Frame
Baseline to 42 days
Title
Change in tooth whitening
Time Frame
Baseline to 42 days
Title
Change in sub-gingival bacterial profile
Description
DNA-DNA Hybridization Checkerboard; Measurement of bacterial load
Time Frame
Baseline to 28 days
Title
Change in inflammatory cytokines
Description
Measurement of IL-1B, TNF-a, IL-6, IL-8 & MCP-1 volume from gingival crevicular fluid samples
Time Frame
Baseline to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Hasturk, DDS, PhD
Organizational Affiliation
The Forsyth Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Forsyth Institute
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Randomized Trial of a Gum Health Formulation

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