Clinical trial NCT03196648: Randomized Trial of a Gum Health Formulation
Official title: A Randomized Trial Evaluating the Efficacy of a Gum Health Formulation on Gingival Inflammation, Oral Malodor and Tooth Whitening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Gingivitis
Periodontitis
Halitosis
Keywords: Gingivitis
Periodontal disease
Inflammation
Teeth whitening
Breath freshening
Periodontal pathogens
Bleeding on probing
Lead sponsor: Glo Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Forsyth Institute
First posted: 2017-06-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of a newly formulated foaming gel product on gingivitis and/or moderate periodontitis when used with or without the GLO Science accelerating device (GLO Device), compared to standard tooth brushing with antioxidant whitening toothpaste with or without flossing (split mouth design for control group).

This is a 60-day randomized single blinded parallel group study. After 42 days, all use of interventional products were discontinued, and the participants returned to the clinical center at day 60 for final measurements. The primary outcomes assessed in this study were the differences in gingival index (GI) and bleeding on probing (BOP) from baseline to 42 \& 60 days. The secondary outcomes are tooth whitening, oral malodor, pocket depth and plaque amount.

It is hypothesized that participants using the gingival health product with the GLO Device will experience greater reductions in GI \& BOP measurements than the control group, as well as participants using the gingival health product on a toothbrush alone.


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 55 years of age
* Male or female
* Minimum of 20 teeth, excluding crowns and third molar teeth
* Mean whole mouth Gingival Index \>/=2.0 at baseline; sites with \</=7mm pocket depth
* Willing to abstain from all oral hygiene procedures 12-18 hours prior to clinical visits
* Willing to abstain from eating and drinking for 2 hours prior to clinical visits, only drinking water is allowed
* Willing to abstain from chewing gums, oral whitening products, mouthwashes and tobacco products for the study duration
* Able to understand and follow study directions

Exclusion Criteria:

* Chronic use of photosensitizing medications including NSAIDs, antidepressants, antibiotics and beta-blockers
* Diagnosed with diabetes
* 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 requiring immediate treatment
* Patients with severe internal (tetracycline stains) and external discoloration (fluorosis)
* Patients with severe chronic periodontitis, aggressive periodontitis, acute necrotizing ulcerative gingivitis, or generalized gingival recession \>2mm as evidenced by clinical oral exam
* Pregnant or breast-feeding women
* Allergy to home bleaching products such as hydrogen peroxide and carbide peroxide
* Use of antibiotics within 3 months of enrollment
* 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 medication 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. Use of low dose of ASA (\<325mg) is permitted.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Current smoking and former smoking within one year of enrollment

Primary outcomes:
measure: Differences in bleeding on probing
timeFrame: Baseline to 42 days
measure: Differences in Gingival Index
timeFrame: Baseline to 42 days
Secondary outcomes:
measure: Difference in Plaque Index
timeFrame: Baseline to 42 days
measure: Difference in mean probing depth
timeFrame: Baseline to 42 days
measure: Change in oral malodor
timeFrame: Baseline to 42 days
measure: Change in tooth whitening
timeFrame: Baseline to 42 days
measure: Change in sub-gingival bacterial profile
timeFrame: Baseline to 28 days
measure: Change in inflammatory cytokines
timeFrame: Baseline to 28 days
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: The Forsyth Institute
state: Massachusetts
Study officials:
affiliation: The Forsyth Institute
name: Hatice Hasturk, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: