Compare Anti-inflammatory Dentifrices
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Nuclear Factor Kappa B Ligand (RANK-L)
研究概览
简要总结
Plaque induced gingivitis
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be adult males or females 18 to 60 years old
- •Subjects must be able and willing to follow study procedures and instructions
- •Subjects must have read, understood and signed an informed consent form
- •Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
- •Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
- •Each subject must have at least four teeth with probing depths of 4-5 mm and at least 30% of sites bleeding to gentle probing
排除标准
- •Subjects who have chronically used (i.e., two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
- •Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
- •Subjects with periodontitis as indicated by periodontal pocketing 6 mm at screening
- •Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
- •Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
- •Subjects with orthodontic appliances or removable partial dentures
- •Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
- •Subjects who currently smoke or who report using tobacco products within one year of screening.
- •Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
- •Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
- •Female subjects who report being pregnant or lactating, or female subjects who are of childbearing potential and who report not using hormonal or barrier methods of birth control (oral or parenteral contraceptives, diaphragm plus spermicide, condoms)
- •Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
- •Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
- •Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
- •Medical condition which precludes not eating/drinking for approximately 8 hours.
研究组 & 干预措施
Total Toothpaste
Triclosan/Copolymer/fluoride toothpaste
干预措施: Triclosan/Copolymer/fluoride toothpaste (Drug)
Fluoride toothpaste
sodium monofluorophosphate toothpaste
干预措施: Sodium monofluorophosphate toothpaste (Drug)
结局指标
主要结局
Nuclear Factor Kappa B Ligand (RANK-L)
时间窗: 29 days
Receptor activator found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
8-iso-prostaglandinF2α (8-iso-PGF2α)
时间窗: 29 days
Inflammatory biomarker found in gingival crevicular fluid (GCF). Presence in GCF may indicate tissue damage as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Gingival Index (GI)
时间窗: 29 days
Gingival Index(GI)recorded on scale of 0-3 detailed below: 0=normal gingiva, 1=Mild inflammation(slight change in color, slight edema)no bleeding on palpation,2=Moderate inflammation(redness,edema,glazing)bleeding upon probing, 3=Severe inflammation(marked redness,edema)ulceration \& tendency to spontaneously bleed
Prostaglandin E2 (PGE2)
时间窗: 29 days
Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Interleukin - 1 Beta (IL-ß)
时间窗: 29 days
Inflammatory biomarkers found in gingival crevicular fluid (GCF) that may be a factor in oral tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
Interleukin-6 (IL-6)
时间窗: 29 days
Inflammatory biomarker found in gingival crevicular fluid (GCF). Higher Levels found in GCF may be a factor in tissue destruction as seen in periodontal disease. All GCF samples are collected onto filter paper strips (Pro Flow, Inc.) and the volume determined by Periotron 8000. Samples were placed in cryovial and labelled, then place into liquid nitrogen and stored at -180°C until analysis.
次要结局
- Dental Plaque Index (PI)(29 days)
- Bleeding on Probing (BOP)(29 days)