Overview
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
Description
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.
Eligibility
Inclusion Criteria:
- Adult subjects aged 18-70, that are in good health.
- Subject must have:
- Baseline gingival inflammation (MGI) score of at least 1.80.
- 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.
Exclusion Criteria:
- 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
