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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
120
test product
negative control
negative control
Clinical Research Facility of the Center for Oral Health and Research, UTHSA
San Antonio, Texas, United States
RECRUITINGModified Gingival Index (MGI)
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.
Time frame: Baseline to 8 weeks
Gingival Bleeding Index (GBI)
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
Time frame: Baseline to 8 weeks
Rustogi Modified Navy Plaque Index (RMNPI)
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).
Time frame: Baseline to 8 weeks
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Measurement of plaque microbiome analysis
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.
Time frame: Baseline to 8 weeks
Satisfaction Questionnaire
A questionnaire containing 11 items: 6 with a potential score of (a) 5=Very High to (e)1=Very Low and 5 free response questions. Total scores range from 6-30 with a higher score indicating greater satisfaction
Time frame: 8 weeks