Functional Chewing Gum in Reduction of Gingival Inflammation
Completed · Not applicable
Conditions studied: Gingivitis
In brief
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.
Key facts
- Study ID
- NCT03237624
- Run by
- University of Maryland, Baltimore
- People needed
- 34
- Starts
- 2018-01-31
- Expected to finish
- 2020-01-31
- Last updated by the study team
- 2024-11-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Mild-moderate gingivitis
- Minimum of 20 natural teeth
You may not qualify if…
- 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.
Where it is running
- University of Maryland School of Dentistry — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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