Assessment of Salivary Flow Promoted by Sugar-Free Chewing Gum in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Salivary flow rate
研究概览
简要总结
This was a double-blind, single center in vivo salivary flow rate study. The objective was to compare a marketed sugar-free chewing gum to a clinically-tested sugar-free reference chewing gum, with regards to their ability to promote salivary flow during a 20-minute chew period in healthy human adult subjects. Two sugar-free chewing gums were randomly assigned and distributed in a cross-over fashion to study subjects over two test period visits. The primary response being measured was salivary flow promoted by sugar-free chewing gums during the 20-minute chewing period.
详细描述
These procedures were conducted in accordance with proposed guidelines for current good clinical practices. Informed consent was obtained in compliance with FDA regulations (21 CFR 50). Each subject read, understood, signed, and received a signed copy of the most current IRB approved informed consent document prior to any study-related procedures being performed. The test and control gums were provided by the Sponsor. One serving size of each gum type was placed in a labeled, small high barrier foil bag to ensure that the subjects and the site personnel received the gum in a blinded manner. During each of the test visits, subjects: 1) provided a non-stimulated saliva sample to ensure continued qualification, 2) received their assigned chewing gum, and 3) provided stimulated saliva over a timed 20-minute chewing period. The primary response being measured was the salivary flow promoted by each chewing gum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be at least 18 years of age
- •have the ability to understand the information contained in the informed consent without the need for cognitive or language interpretation from any other person or source
- •read, comprehend and sign the Informed Consent and other necessary paperwork prior to initiation of study procedures
- •be in good general health based on his/her medical and dental history
- •have a reasonably functional dentition with a minimum of 20 natural teeth (8 of which are posterior teeth)
- •chew gum at least occasionally, no less than one time per month
- •have normal salivary flow as demonstrated by being able to expectorate ≥ 1.5 mL (0.3 mL/min) of whole non-stimulated saliva over a 5-minute period
- •be willing to participate in the study, be able to follow the study directions, and be willing to return for all specified visits at their appointed time, and
- •be willing to postpone all elective dental procedures, at the Principal Investigator/Examiner's discretion, until the study has been completed.
排除标准
- •advanced periodontal disease
- •five or more grossly decayed, untreated dental sites (cavities)
- •pathologic lesions of the oral cavity (suspicious or confirmed)
- •full or partial dentures, or fixed orthodontic appliances, with the exception of a fixed, lower lingual retainer
- •(if female) a medical history indicating that the subject is pregnant or currently breastfeeding
- •current participation in another clinical research study or recent participation in another clinical trial (within 30 days of the study start date) may be cause for exclusion, based on the discretion of the Principal Investigator/Dental Examiner
- •a history of a true allergy or intolerance to gum ingredients, including (but not limited to) sweeteners, colors or flavors, mint, peppermint, spearmint, milk proteins, or other ingredients which may be present in the study products
- •Have a serious medical illness or disorder, e.g., immune compromised, AIDs, etc., that would be unduly affected by participation in this study, per the Principal Investigator/Dental Examiner's discretion
- •a history of PKU (an intolerance to phenylalanine)
- •a true food allergy to soy, or
- •a history of temporomandibular disorder (TMD).
结局指标
主要结局
Salivary flow rate
时间窗: 20 min
Rate of healthy, adult human salivary flow rate while chewing sugar free gum
次要结局
未报告次要终点