Oil Pulling Reduction

NCT07706647 | Recruiting

• 1 other identifier: STUDY00001243
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Good Health; Gingival Inflammation and Bleeding; Dental Plaque

Keywords

mouthwash; gingivitis; plaque; dental

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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).

  Baseline to 8 weeks

• 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.

  Baseline to 8 weeks

Secondary Outcomes (1)

• Satisfaction Questionnaire

  8 weeks

Study Arms (3)

Test Product

EXPERIMENTAL

Dietary Supplement: GuruNanda natural Oil Pulling oral rinse

Positive Control

ACTIVE COMPARATOR

Dietary Supplement: TheraBreath Plaque Control Oral Rinse

Negative Control

PLACEBO COMPARATOR

Negative Control

Dietary Supplement: GuruNanda water-based non-whitening mouthwash

Interventions

GuruNanda natural Oil Pulling oral rinse DIETARY_SUPPLEMENT

test product

Test Product

TheraBreath Plaque Control Oral Rinse DIETARY_SUPPLEMENT

negative control

Positive Control

GuruNanda water-based non-whitening mouthwash DIETARY_SUPPLEMENT

negative control

Negative Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• GuruNanda LLC: collaborator

Study Sites (1)

Clinical Research Facility of the Center for Oral Health and Research, UTHSA

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Gingivitis; Hemorrhage; Dental Plaque; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases; Pathological Conditions, Anatomical

Central Study Contacts

Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI

CONTACT

210-567-3185; amaechi@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Cariology, Department of Comprehensive Dentistry

Model Details: This is a randomized, double-blind, placebo- and positive-controlled, stratified parallel group clinical trial.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)