Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of 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
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
- •Able to attend once daily session during weekdays for flossing and rinsing occurring on site
- •Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
- •Able to read and understand the local language (participants capable of reading the documents)
- •Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect)
- •A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
- •A minimum of 10 bleeding sites based on the BI
- •Absence of advanced periodontitis based on a clinical examination at Baseline and discretion of the dental examiner
排除标准
- •History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
- •Dental prophylaxis within four weeks prior to Screening/Baseline visit
- •History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
- •Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses within the two weeks prior to Baseline
研究组 & 干预措施
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)
Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
干预措施: Colgate Cavity Protection Toothpaste (Other)
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)
Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
干预措施: American Dental Association (ADA) Referenced Toothbrush (Other)
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)
Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
干预措施: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed) (Other)
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
干预措施: Colgate Cavity Protection Toothpaste (Other)
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
干预措施: American Dental Association (ADA) Referenced Toothbrush (Other)
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
干预措施: 5% Hydroalcohol Mouth Rinse (Other)
Group 3: Flossing Performed by Dental Hygienist
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
干预措施: Colgate Cavity Protection Toothpaste (Other)
Group 3: Flossing Performed by Dental Hygienist
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
干预措施: American Dental Association (ADA) Referenced Toothbrush (Other)
Group 3: Flossing Performed by Dental Hygienist
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
干预措施: REACH Dental Floss (Other)
Group 4: Flossing under Supervision
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
干预措施: Colgate Cavity Protection Toothpaste (Other)
Group 4: Flossing under Supervision
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
干预措施: American Dental Association (ADA) Referenced Toothbrush (Other)
Group 4: Flossing under Supervision
Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
干预措施: REACH Dental Floss (Other)
结局指标
主要结局
Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
时间窗: 12 Weeks
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
时间窗: 12 Weeks
Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2- Mild inflammation of the entire gingival unit; 3- Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4- Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
次要结局
- Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks(4 Weeks and 12 Weeks)
- Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use(4 Weeks)
- Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use(4 Weeks)
- Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)