Use of a Functional Chewing Gum in Reduction of Gingival Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Gum inflammation change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild-moderate gingivitis
- •Minimum of 20 natural teeth
排除标准
- •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.
结局指标
主要结局
Gum inflammation change
时间窗: Change in color of gingiva from baseline to 12 weeks
Measure the color of gingiva - use Gingiva Index
次要结局
- Plaque levels (on teeth) change(Change in plaque level from baseline to 12 weeks)
研究者
Harlan Shiau
Clinical Associate Professor
University of Maryland, Baltimore