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

NCT ID: NCT02906982

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-04-30

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.

Conditions

Tooth Discoloration; Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gum health formulation in intra-oral device

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.

Group Type: EXPERIMENTAL

Gum health formulation in intra-oral device

Intervention Type: OTHER

The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.

Gum health formulation on toothbrush

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.

Group Type: EXPERIMENTAL

Gum health formulation on toothbrush

Intervention Type: OTHER

The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.

Control group (split-mouth design)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gum health formulation in intra-oral device

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

Gum health formulation on toothbrush

The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.

Intervention Type: OTHER

Other Intervention Names

ECO Balance; GLO Science intra-oral accelerating device; ECO Balance

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EEC Institute, Inc.

OTHER

Sponsor Role: collaborator

Glo Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edgard El Chaar, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

EEC Institute, Inc.

Locations

EEC Institute, Inc.

New York, New York, United States

Countries

United States

Other Identifiers

GLO-001

Identifier Type: -

Identifier Source: org_study_id