Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
Launched by GLO SCIENCE, INC. · Sep 15, 2016
Trial Information
Current as of October 11, 2025
Completed
Keywords
ClinConnect Summary
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...
Gender
ALL
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
About Glo Science, Inc.
Glo Science, Inc. is a leading innovator in the field of oral health and cosmetic dentistry, specializing in advanced teeth whitening solutions and oral care products. Committed to enhancing patient outcomes through scientific research and development, the company focuses on creating safe, effective, and user-friendly products that promote healthier smiles. Glo Science, Inc. leverages cutting-edge technology and clinical expertise to drive its clinical trials, ensuring that their offerings meet the highest standards of efficacy and safety. With a dedication to improving the patient experience, Glo Science continues to pioneer advancements in dental aesthetics and oral hygiene.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Trial Officials
Edgard El Chaar, DDS, MS
Principal Investigator
EEC Institute, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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