Functional Chewing Gum in Reduction of Gingival Inflammation
| Status: | Recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/12/2018 |
| Start Date: | January 31, 2018 |
| End Date: | January 31, 2019 |
| Contact: | Harlan Shiau, DDS/DMSc |
| Email: | hshiau@umaryland.edu |
| Phone: | 410-941-9427 |
Use of a Functional Chewing Gum in Reduction of Gingival Inflammation
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.
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.
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.
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.
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%)*
- Smoking
- Pregnancy
- Use of any oral rinses such as, but not limited to chlorhexidine, essential oils,
cetylpyridinium chloride during the study.
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