Clinical Study to Evaluate the Comparative Efficacy of Floss, Essential Oil Mouthwashes, and an Alcohol-free CPC+Zn Mouthwash in Reducing Dental Plaque and Gingivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Interproximal mean Modified Gingival Index (MGI)
研究概览
简要总结
The objective of this clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (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
- 是
入选标准
- •Male or female volunteers at least 18 years of age and in general good health.
- •Willing and able to understand and sign the informed consent form.
- •Whole mouth mean MGI ≥1.95, whole mouth mean TPI≥1.95, and ≥10% bleeding sites
- •Be willing to conform to the study protocol and procedures.
- •No sites with probing depth >4 mm.
- •Minimum of 20 natural teeth with scorable facial and lingual surfaces
排除标准
- •Medical condition which requires premedication prior to dental visits/procedure.
- •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.
- •Active disease of the hard oral tissues.
- •Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- •Moderate to severe periodontitis (stages II-IV) per the EFP S3 guidelines.
- •Subjects with fixed or removable orthodontic appliances or removable partial dentures.
- •Dental prophylaxis within 30 days prior to study start.
- •Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
- •Use of chemotherapeutic oral care products within two weeks prior to study start.
- •Participation in any other clinical study within 30 days prior to enrollment into this study.
- •Subjects who must receive dental treatment during the study dates.
- •Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- •Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- •Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
- •Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.
- •Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- •Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
研究组 & 干预措施
Brushing and Rinsing C
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds.
干预措施: Mouthwash (Drug)
Brushing and Rinsing C
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds.
干预措施: Toothbrush (Device)
Brushing
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator).
干预措施: Toothbrush (Device)
Brushing
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator).
干预措施: Toothpaste (Drug)
Brushing and Flossing
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site.
干预措施: Floss (Device)
Brushing and Flossing
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site.
干预措施: Toothbrush (Device)
Brushing and Flossing
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site.
干预措施: Toothpaste (Drug)
Brushing and Rinsing A
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds.
干预措施: Mouthwash (Drug)
Brushing and Rinsing A
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds.
干预措施: Toothbrush (Device)
Brushing and Rinsing A
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds.
干预措施: Toothpaste (Drug)
Brushing and Rinsing B
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds.
干预措施: Mouthwash (Drug)
Brushing and Rinsing B
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds.
干预措施: Toothbrush (Device)
Brushing and Rinsing B
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds.
干预措施: Toothpaste (Drug)
Brushing and Rinsing C
Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds.
干预措施: Toothpaste (Drug)
结局指标
主要结局
Interproximal mean Modified Gingival Index (MGI)
时间窗: 12 weeks
MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Interproximal MGI includes the mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness 1. = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary 2. = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary 3. = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary 4. = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration
次要结局
- Whole Mouth mean Modified Gingival Index (MGI)(1, 4, and 12 weeks)
- Interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)(1, 4, and 12 weeks)
- Whole Mouth mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)(1, 4, and 12 weeks)
- Interproximal mean Expanded Bleeding Index (EBI)(1, 4, and 12 weeks)
- Whole Mouth Expanded Bleeding Index (EBI)(1, 4, and 12 weeks)
- Interproximal mean Bleeding on Probing (BOP)(12 weeks)
- Whole Mouth mean Bleeding on Probing (BOP)(12 weeks)
- Interproximal mean Probing Depth (PD)(12 weeks)
- Whole Mouth mean Probing Depth (PD)(12 weeks)