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

NCT02906982 | Completed

• 1 other identifier: GLO-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 14, Day 28, Day 45

Secondary Outcomes (4)

• Plaque Index

  Baseline, Day 14, Day 28, Day 45

• Gingival Index

  Baseline, Day 14, Day 28, Day 45

• Bleeding Index

  Baseline, Day 14, Day 28, Day 45

• Mean Probing Depth

  Baseline, Day 14, Day 28, Day 45

Study Arms (3)

Gum health formulation in intra-oral device

EXPERIMENTAL

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.

Other: Gum health formulation in intra-oral device

Gum health formulation on toothbrush

EXPERIMENTAL

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.

Other: Gum health formulation on toothbrush

Control group (split-mouth design)

NO INTERVENTION

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.

Interventions

Gum health formulation in intra-oral device OTHER

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

Also known as: ECO Balance, GLO Science intra-oral accelerating device

Gum health formulation in intra-oral device

Gum health formulation on toothbrush OTHER

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

Also known as: ECO Balance

Gum health formulation on toothbrush

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glo Science, Inc.: lead
• EEC Institute, Inc.: collaborator

Study Sites (1)

EEC Institute, Inc.

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Tooth Discoloration; Periodontal Diseases; Periodontitis; Gingivitis

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Mouth Diseases; Infections; Gingival Diseases

Study Officials

• Edgard El Chaar, DDS, MS

  EEC Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 20, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: April 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

US (1)