Clinical Trial 40904

Baltimore, MD 21201

Study 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.

Qualified Participants Must:

• Be 18 years or older
• Have mild to moderate gingivitis
• Have a minimum of 20 natural teeth

Exclusion Criteria:

  • Significant alveolar bone loss as evidenced by Bite-wings (greater than 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 greater than 7.9%)*
  • Smoking
  • Pregnancy
  • Use of any oral rinses such as, but not limited to chlorhexidine, essential oils, cetylpyridinium chloride during the study.

Qualified Participants May Receive:

  • Three dental check-ups at no cost
  • Payment up to $500 at study completion

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.