Health TrialsbyHealthPanel

Oil Pulling Reduction

ConditionsGood HealthGingival Inflammation and BleedingDental Plaque
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult subjects aged 18-70, that are in good health.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GuruNanda natural Oil Pulling oral rinse

    Dietary supplement

    test product

  • TheraBreath Plaque Control Oral Rinse

    Dietary supplement

    negative control

  • GuruNanda water-based non-whitening mouthwash

    Dietary supplement

    negative control

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Test ProductExperimental treatment 1 intervention
Group B: Positive ControlActive comparator 1 intervention
Group C: Negative ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified 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
2

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
3

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
4

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

GuruNanda LLC

Collaborator

Source ClinicalTrials.gov
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