Clinical Investigation to Assess the Efficacy of a Eugenol-based Product in Improving the Quality of Toothbrushing Measured by Plaque Assessment and Patient Perception Questionnaire and Relieving Gum Discomfort Areas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Turesky Modification of the Quigley & Hein Plaque Index
研究概览
简要总结
The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You must provide consent to participate by signing this informed consent form.
- •Available for the two(2) week study duration.
- •You must be at least eighteen(18) years old and not older than seventy(70) years of age.
- •You must not smoke.
- •You must be in good general health for participation in the study, based on the opinion of the study investigator.
- •You must have at least 20 natural permanent teeth.
- •Your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner.
- •You must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire.
- •You must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
排除标准
- •Medical condition which requires premedication prior to dental visits/procedures.
- •Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations.
- •Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months.
- •Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care.
- •Abnormalities/diseases of the soft or hard oral tissues.
- •Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
- •Current smokers and/or tobacco users and/or a history of alcohol or drug abuse.
- •Use of drugs that can affect salivary flow.
- •Use of antibiotics one (1) month prior to study entry and/or during participation in this study.
- •Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion.
- •Self-reported pregnancy and/or breastfeeding.
- •Current Participation in another clinical study or during the month prior to this clinical study entry.
- •Known allergies and/or reactions to common dentifrice ingredients.
- •Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits.
- •Immunocompromised conditions (AIDS, immunosuppressive drug therapy).
- •Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
研究组 & 干预措施
Group 1
toothpaste and gum product, brushing 2x a day for 2 minutes followed by gum product application
干预措施: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product (Drug)
Group 2
toothpaste , brushing 2x a day for 2 minutes
干预措施: fluoride toothpaste containing 1450 ppm of MFP in a PCC base (Drug)
结局指标
主要结局
Turesky Modification of the Quigley & Hein Plaque Index
时间窗: baseline and six months
Reduction in plaque measurement is served as primary efficacy variable are served. The scoring scheme for the Turesky Modification of the Quigley-Hein dental plaque index is as follows: 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
次要结局
- questionnaire(six months)