Evaluation of Oil Pulling Mouthwash for Reduction of Dental Plaque, Gingivitis, and Selective Reduction of Bacteria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Modified Gingival Index (MGI)
研究概览
简要总结
The goal of this study is to scientifically evaluate the efficacy of this oil pulling oral rinse in reducing dental plaque, gingival inflammation, gingival bleeding, and selectively reducing caries- and periodontal disease-associated bacteria compared to a marketed mouthwash and a placebo oral rinse
详细描述
A total of 120 subjects who met all necessary requirements for selection as subjects will be stratified into three balanced groups (40 per group) according to age, gender, and their mean baseline gingivitis index measured using the Modified Gingival Index (MGI). The three groups will be randomly assigned to use one of three test mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). Subjects will be instructed to use their assigned mouthwash as an adjunct oral hygiene product for the 8-week treatment duration. All subjects will be provided with the same brand of toothpaste (non-antimicrobial) and a soft-bristled toothbrush to use for their routine daily toothbrushing for the 8-week treatment duration. All study products will be used according to their manufacturers' instructions. However, to facilitate blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility. The clinical Examiner and other study team members will not discuss product-use with the subjects. All mouthwash will be used once daily before bed at night, while toothbrushing will be performed twice daily in the morning and before bed at night. For each test subject, assessment data will be collected at baseline, 4 weeks, and 8 weeks. Data will be collected on gingival inflammation, gingival bleeding, and dental plaque, using Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Rustogi Modification of the Navy Plaque Index (RMNPI), respectively. The average summary scores will be calculated for each group on each of these indices. Supragingival plaque samples will be collected for plaque microbiome analysis at baseline, 4 weeks, and 8 weeks. All dental examinations for data collection in all 120 subjects will be conducted by the same Clinical Examiner throughout the study. Subjects will be examined and queried on adverse events at each study visit.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
To facilitate double blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility. The clinical Examiner and other study team members will not discuss product-use with the subjects.
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
- 否
入选标准
- •Adult subjects aged 18-70, that are in good health.
- •Subject must have:
- •Baseline gingival inflammation (MGI) score of at least 1.
- •Baseline gingival bleeding (GBI) score of ≥ 1 on at least 20 sites.
- •An overnight (12 to 18 hour abstention from any oral hygiene) dental plaque (mean) score greater than 0.6 according to the RMNPI Index.
- •Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
- •The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
- •The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits.
排除标准
- •Current or history of oral cavity cancer or oropharyngeal cancer.
- •Subject with destructive periodontal disease or those on antibiotic or anti-inflammatory drugs.
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
- •Pregnant or nursing by subject report.
- •Known allergic reaction to any of the study mouthwashes or any of their component.
- •Any active condition, including but not limited to advanced periodontal disease or severe gingival recession, in the oral cavity at the discretion of the investigator.
- •Any surgery or recent dental procedure in the oral cavity within 3 months prior to treatment, or before complete healing.
- •Subjects that do not brush regularly.
- •Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
- •History of allergy or hypersensitivity to mouthwash ingredients
- •Significant medical conditions, such as uncontrolled diabetes or immunosuppressive disorders
- •Use of tobacco products, including cigarettes and smokeless tobacco
- •Presence of orthodontic appliances, except for removable retainers
- •Participation in another clinical trial within the last 30 days.
- •Individuals unable to comply with study requirements, such as regular product use or scheduled visits.
- •Habitual use of alcohol or drugs that may affect compliance or oral health
结局指标
主要结局
Modified Gingival Index (MGI)
时间窗: Baseline to 8 weeks
The gingiva will be segmented into 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces). Gingival inflammation will be recorded at each tooth site on a scale of 0 to 4: Gingivitis will be assessed by the 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 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.
Gingival Bleeding Index (GBI)
时间窗: Baseline to 8 weeks
A full mouth bleeding assessment will be performed based on the Gingival Bleeding Index. The gingiva should be gently dried and lightly swept with a 0.5 diameter periodontal probe (to be used for each subject for all visits). The probe will be engaged approximately 1 millimeter (mm) into the gingival crevice at an angle to the tooth. A moderate pressure will be used while sweeping from interproximal to interproximal along the sulcular epithelium. The gingiva will be segmented into 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces). Bleeding or the absence of bleeding will be assessed at each tooth site on a scale of 0 to 3. Subjects with less than 20 bleedings sites at Visit 1 will be dismissed from the study. The GBI Scoring System to be used is as follows: 0 - No bleeding after 30 seconds 1. \- Bleeding upon probing after 30 seconds 2. \- Immediate bleeding observed
Rustogi Modified Navy Plaque Index (RMNPI)
时间窗: Baseline to 8 weeks
Plaque examinations will be performed using the Rustogi Modified Navy Plaque Index (RMNPI)1. Subjects' will swish with 5 mls of a disclosing solution for 10 seconds and expectorate followed by 10 mls of water for 10 seconds. After disclosing, the plaque on each tooth will be evaluated as present (1) or absent (0).
Measurement of plaque microbiome analysis
时间窗: Baseline to 8 weeks
Supragingival plaque samples will be collected from molar and pre-molar teeth region using the sterile curettes. To minimize contamination, subjects will avoid eating; drinking (except water) and oral hygiene practices for one hour before collection. Samples will be transferred immediately into sterile DNA preserving micro-centrifuge tubes and stored at -80 until analysis.
次要结局
- Satisfaction Questionnaire(8 weeks)
研究者
Bennett Amaechi
Professor and Director of Cariology, Department of Comprehensive Dentistry
The University of Texas Health Science Center at San Antonio