Clinical trial NCT02906982: Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
Official title: A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Glo Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: EEC Institute, Inc.
First posted: 2016-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Tooth Shade Value over 45 Days
timeFrame: Baseline, Day 14, Day 28, Day 45
Secondary outcomes:
measure: Plaque Index
timeFrame: Baseline, Day 14, Day 28, Day 45
measure: Gingival Index
timeFrame: Baseline, Day 14, Day 28, Day 45
measure: Bleeding Index
timeFrame: Baseline, Day 14, Day 28, Day 45
measure: Mean Probing Depth
timeFrame: Baseline, Day 14, Day 28, Day 45
Other outcomes:
Locations:
city: New York
country: United States
facility: EEC Institute, Inc.
state: New York
Study officials:
affiliation: EEC Institute, Inc.
name: Edgard El Chaar, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: