search
Back to results

Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis

Primary Purpose

Tooth Discoloration, Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gum health formulation in intra-oral device
Gum health formulation on toothbrush
Sponsored by
Glo Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Discoloration focused on measuring Periodontal diseases, Periodontitis, Gingivitis, Teeth Whitening, Dental Plaque Index, Periodontal Index, Teeth Whitening Agents, Tooth Discoloration, Mean Probing Depth, Pocket Depth

Eligibility Criteria

18 Years - 65 Years (Adult, Older 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 65 years of age
  • A minimum of 20 teeth, excluding crowns and third molar teeth
  • A mean whole mouth Gingival Index score of >2.0 at baseline
  • Sites with <7mm pocket depth
  • Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits
  • Willing to abstain from eating and drinking in the morning of visits, only drinking water
  • Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration
  • Ability to understand and follow study protocol
  • No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products

Exclusion Criteria:

  • Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta blockers
  • Diagnosis of diabetes mellitus
  • 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
  • Severe internal (tetracycline stains) and external discolouration (fluorosis)
  • Diagnosis of severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis or generalized gingival recession >2mm as evidenced by clinical oral exam
  • Participating in another clinical trial or oral product study
  • Pregnant or breast-feeding women
  • Allergy to home bleaching products such as hydrogen peroxide and carbamide peroxide
  • Use of antibiotics within 3 months of enrolment
  • 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 medications 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
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Smokers
  • Patients who have received quadrant or maintenance scaling & root planing and/or periodontal surgical therapy within 6 months prior to enrolment

Sites / Locations

  • EEC Institute, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Gum health formulation in intra-oral device

Gum health formulation on toothbrush

Control group (split-mouth design)

Arm Description

The interventional gum health formulation is applied to the participant's mouth by means of an intra-oral device for a single eight-minute application, daily. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night.

The interventional gum health formulation is applied to the participant's mouth by means of a toothbrush and toothpaste, plus the gum health formulation, for two-minute applications, twice daily, morning and night.

The control group did not receive the interventional gum health formulation. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. In addition, participants instructed to floss only half of their mouth daily, and the non-flossed half serves as the untreated comparative control receiving no intervention.

Outcomes

Primary Outcome Measures

Change from Baseline Tooth Shade Value over 45 Days
Tooth Shade Value was measured using a Vita Shade Guide and the measurement was transformed to a standardized value.

Secondary Outcome Measures

Plaque Index
Periodontal probe will be swept along the buccal and lingual surfaces and plaque is noted.
Gingival Index
Periodontal probe will be placed under the gingival margin and swept along the buccal and lingual surfaces and bleeding is noted.
Bleeding Index
Bleeding will be assessed after probing. A dichotomous scoring system is used at six sites per tooth using one and zero for presence or absence, respectively.
Mean Probing Depth
Pocket depth will be determined with a UNC-15 periodontal probe at six sites per tooth rounded to the next lower whole millimeter.

Full Information

First Posted
September 13, 2016
Last Updated
September 15, 2016
Sponsor
Glo Science, Inc.
Collaborators
EEC Institute, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02906982
Brief Title
Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
Official Title
A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when used in an intra-oral device or on a toothbrush, for teeth whitening and clinical improvements in periodontal diseases.
Detailed Description
Over half of the American population suffers from some form of periodontal disease, while millions of Americans are electing for teeth whitening procedures every year. The study is designed to assess the efficacy of a novel gum health formulation on teeth whitening in the context of gingival inflammation. Further, the study aims to assess the efficacy of the novel gum health formulation as an adjunct to the current standard of care in the treatment of gingivitis and periodontitis, depending on the severity of disease. As the dental professional community is whitening teeth in an environment of gingival inflammation, a single product that whitens teeth and controls inflammation is a novel treatment approach and highly desirable among patients and consumers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Discoloration, Periodontal Diseases
Keywords
Periodontal diseases, Periodontitis, Gingivitis, Teeth Whitening, Dental Plaque Index, Periodontal Index, Teeth Whitening Agents, Tooth Discoloration, Mean Probing Depth, Pocket Depth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gum health formulation in intra-oral device
Arm Type
Experimental
Arm Description
The interventional gum health formulation is applied to the participant's mouth by means of an intra-oral device for a single eight-minute application, daily. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night.
Arm Title
Gum health formulation on toothbrush
Arm Type
Experimental
Arm Description
The interventional gum health formulation is applied to the participant's mouth by means of a toothbrush and toothpaste, plus the gum health formulation, for two-minute applications, twice daily, morning and night.
Arm Title
Control group (split-mouth design)
Arm Type
No Intervention
Arm Description
The control group did not receive the interventional gum health formulation. Participants instructed to brush their teeth with a toothbrush and toothpaste twice daily, morning and night. In addition, participants instructed to floss only half of their mouth daily, and the non-flossed half serves as the untreated comparative control receiving no intervention.
Intervention Type
Other
Intervention Name(s)
Gum health formulation in intra-oral device
Other Intervention Name(s)
ECO Balance, GLO Science intra-oral accelerating device
Intervention Description
The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.
Intervention Type
Other
Intervention Name(s)
Gum health formulation on toothbrush
Other Intervention Name(s)
ECO Balance
Intervention Description
The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.
Primary Outcome Measure Information:
Title
Change from Baseline Tooth Shade Value over 45 Days
Description
Tooth Shade Value was measured using a Vita Shade Guide and the measurement was transformed to a standardized value.
Time Frame
Baseline, Day 14, Day 28, Day 45
Secondary Outcome Measure Information:
Title
Plaque Index
Description
Periodontal probe will be swept along the buccal and lingual surfaces and plaque is noted.
Time Frame
Baseline, Day 14, Day 28, Day 45
Title
Gingival Index
Description
Periodontal probe will be placed under the gingival margin and swept along the buccal and lingual surfaces and bleeding is noted.
Time Frame
Baseline, Day 14, Day 28, Day 45
Title
Bleeding Index
Description
Bleeding will be assessed after probing. A dichotomous scoring system is used at six sites per tooth using one and zero for presence or absence, respectively.
Time Frame
Baseline, Day 14, Day 28, Day 45
Title
Mean Probing Depth
Description
Pocket depth will be determined with a UNC-15 periodontal probe at six sites per tooth rounded to the next lower whole millimeter.
Time Frame
Baseline, Day 14, Day 28, Day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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 65 years of age A minimum of 20 teeth, excluding crowns and third molar teeth A mean whole mouth Gingival Index score of >2.0 at baseline Sites with <7mm pocket depth Willing to abstain from all oral hygiene procedures for 12-18 hours prior to clinical visits Willing to abstain from eating and drinking in the morning of visits, only drinking water Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration Ability to understand and follow study protocol No known history of allergy to dairy products or their ingredients, relevant to any ingredient in the test products Exclusion Criteria: Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta blockers Diagnosis of diabetes mellitus 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 Severe internal (tetracycline stains) and external discolouration (fluorosis) Diagnosis of severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis or generalized gingival recession >2mm as evidenced by clinical oral exam Participating in another clinical trial or oral product study Pregnant or breast-feeding women Allergy to home bleaching products such as hydrogen peroxide and carbamide peroxide Use of antibiotics within 3 months of enrolment 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 medications 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 Medical condition which requires pre-medication prior to dental visits/procedures Smokers Patients who have received quadrant or maintenance scaling & root planing and/or periodontal surgical therapy within 6 months prior to enrolment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgard El Chaar, DDS, MS
Organizational Affiliation
EEC Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
EEC Institute, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis

We'll reach out to this number within 24 hrs