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.
Other: Gum health formulation in intra-oral device
Other: Gum health formulation on toothbrush
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Locations near you
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Full eligibility criteria for NCT02906982
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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
Patients who have received quadrant or maintenance scaling & root planing and/or periodontal surgical therapy within 6 months prior to enrolment
All locations for NCT02906982
United States (1)
EEC Institute, Inc.
New York, New York, United States, 10016
View full eligibility
Tris trial is registered with FDA with number: NCT02906982. The sponsor of the trial is Glo Science, Inc. and it is looking for 30 volunteers for the current phase.
Official trial title: A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
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