Use of a Functional Chewing Gum in Reduction of Gingival Inflammation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Gum inflammation change
Study Overview
Brief Summary
The aim of this prospective randomized 3-month double-blinded single center study is to determine whether a chewing gum device with food additive chitosan, will aid in reducing gingival inflammation by supplementing traditional tooth brushing and flossing measures. Patients with mild to moderate gingivitis will be identified and enrolled in this investigation. All enrolled subjects will receive baseline oral hygiene brushing instructions and a baseline clinical examination of the gingiva. The test group will utilize the test chewing gum three times a day for a minimum 20-30 minutes duration; the control group will receive a placebo gum and use it in a similar manner. We will examine whether daily use of a functional chewing gum enhances improvements to brushing and flossing.
Detailed Description
Periodontal disease remains a prevalent and preventable disease in man. Plaque bacterial biofilm remains the primary etiologic agent of disease; colonization of non-shedding tooth surfaces greatly contributes to initiation and progression of gingivitis, for example. Although there are currently available chemotherapeutic agents to supplement daily oral hygiene measures, one continuous issue is patient compliance. Chewing gum represents a unique delivery device for not only drugs and other agents, but food additives that might aid in reducing bacteria plaque colonization on tooth surfaces. For example, chitosan and chitosan-related food additive preparations have been shown to have some antimicrobial-like properties, possibly in the disruption of bacterial colonization (not -cidal).
NOTE: ALL INGREDIENTS of the "test" chewing gum, and the placebo chewing gum, are generally regarded as safe ("GRAS" label by the Food and Drug Administration), as they are common food components. For example, chitosan is listed in the GRAS database (https://www.accessdata.fda.gov/scripts/fdcc/?set=SCOGS). See item GRN No. 397.
This study aims to determine whether adjunctive use of functional chewing gum will improve gingival inflammation status-retaining clinical gains initiated by professional tooth cleaning and at home brushing over a 12 week period in gingivitis patients.
Eligibility criteria and outcome measures are described in the next section.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Mild-moderate gingivitis
- •Minimum of 20 natural teeth
Exclusion Criteria
- •Significant alveolar bone loss as evidenced by Bite-wings (>3.0 mm cementoenamel junction to bone)
- •Requirement for antibiotic pre-medication prior to dental procedures
- •Systemic antibiotic use in past 14 days to current.
- •Use of oral contraceptives
- •Use of anti-inflammatory (NSAIDs) or in past 14 days.
- •Use of anticoagulant therapy or in past 14 days.
- •Poorly controlled diabetes (HbA1c > 7.9%)*
- •Pregnancy
- •Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.
Outcomes
Primary Outcomes
Gum inflammation change
Time Frame: Change in color of gingiva from baseline to 12 weeks
Measure the color of gingiva - use Gingiva Index
Secondary Outcomes
- Plaque levels (on teeth) change(Change in plaque level from baseline to 12 weeks)
Investigators
Harlan Shiau
Clinical Associate Professor
University of Maryland, Baltimore