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

Completed · Not applicable

Conditions studied: Tooth Discoloration, Periodontal Diseases

In brief

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.

Key facts

Study ID

NCT02906982

Run by

Glo Science, Inc.

People needed

30

Starts

2015-10-01

Expected to finish

2016-04-01

Last updated by the study team

2016-09-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• EEC Institute, Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

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