EUCTR2009-015914-23-GB进行中（未招募）不适用
Clinical efficacy of an experimental toothpaste
GlaxoSmithKline Consumer Healthcare (GSKCH)0 个研究点开始时间: 2009年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- •Aged at least 18 years.
- •3.Compliance
- •Understands and is willing, able and likely to comply with all study procedures and restrictions.
- •4.General Health
- •Good general health in the opinion of the investigator, with no clinically significant and relevant abnormalities of medical history or physical examination.
- •5.Dental Health
- •a)A minimum of 20 permanent gradable teeth. A scorable surface is defined as a surface that has 50% of the surface gradable. Third molars, orthodontically banded/ bonded, fully crowned or extensively restored, grossly carious or abutment teeth are not included in the tooth count.
- •b)Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.
- •c)MGI between 1.50 and 2.30 at Pre-Prophy Baseline and Randomisation visit.
- •d)Reduction in MGI between Pre-Prophy Baseline and Randomisation visit.
- •e)All teeth required for plaque sampling are present (for sub-set of subjects undergoing plaque sampling only).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnancy
- •Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- •2.Breast-feeding
- •Women who are breast–feeding.
- •3.Allergy/Intolerance
- •Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •4.Dental Health
- •a)Have current active caries or periodontitis that may compromise the study or the health of the subjects in the opinion of the investigator or MGI examiner.
- •b)Restorations in a poor state of repair.
- •c)Partial dentures or orthodontic appliances.
- •Current smokers or smokers who have quit within the past 6 months prior to screening.
- •6.Medication
- •a)Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to gingival health examinations.
- •b)Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival health examinations (e.g. calcium channel blockers, ibuprofen or aspirin therapy).
- •7.Clinical Study/Experimental Medication
- •a)Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- •b)Previous participation in this study.
- •8.Substance abuse
- •Recent history (within the last year) of alcohol or other substance abuse.
- •9.Personnel
- •a)An employee of the sponsor or the study site or members or their immediate family.
- •b)An employee of any toothpaste manufacturer or their immediate family.
研究者
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