Good HealthNCT07706647
Oil Pulling Reduction
A study testing GuruNanda natural Oil Pulling oral rinse and GuruNanda water-based non-whitening mouthwash in people with Good Health and Gingival Inflammation and Bleeding, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Good Health, Gingival Inflammation and Bleeding, Dental Plaque
- What is being tested?
- GuruNanda natural Oil Pulling oral rinse and GuruNanda water-based non-whitening mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Research Facility of the Center for Oral Health and Research, UTHSA
San Antonio, Texas, 78229
Bennett T Amaechi, BDS, MS, PhD, 210-567-3185, amaechi@uthscsa.edu
vohrar@uthscsa.edu
About this study
Official title: Evaluation of Oil Pulling Mouthwash for Reduction of Dental Plaque, Gingivitis, and Selective Reduction of Bacteria
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
Read the detailed 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.
- Being tested
- GuruNanda natural Oil Pulling oral rinse, TheraBreath Plaque Control Oral Rinse, GuruNanda water-based non-whitening mouthwash
- Keywords
- mouthwash, gingivitis, plaque, dental
- Medical subject headings
- Gingivitis, Hemorrhage, Dental Plaque, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuruNanda natural Oil Pulling oral rinseDietary supplement
test product
TheraBreath Plaque Control Oral RinseDietary supplement
negative control
GuruNanda water-based non-whitening mouthwashDietary supplement
negative control
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Not described Receives: Dietary Supplement: GuruNanda natural Oil Pulling oral rinse |
| Positive Control | Active comparator | Not described Receives: Dietary Supplement: TheraBreath Plaque Control Oral Rinse |
| Negative Control | Placebo comparator | Negative Control Receives: Dietary Supplement: GuruNanda water-based non-whitening mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit
- - Mild inflammation of the entire gingival unit
- - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit
- - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: 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
- - Bleeding upon probing after 30 seconds
- - Immediate bleeding observed
Measured: 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).
Measured: 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.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start8 Jul 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Good HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo- and positive-controlled, stratified parallel group clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- GuruNanda LLC
- Responsible party
- Principal investigator, Bennett Amaechi, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706647
- Sponsor's protocol ID
- STUDY00001243
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oil Pulling Mouthwash for Reduction of Dental Plaque, Gingivitis, and Selective Reduction of Bacteria
- ClinicalTrials.gov ID
- NCT07706647
- Acronym / sponsor ID
- STUDY00001243
- Keywords
- mouthwash, gingivitis, plaque, dental
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- GuruNanda LLC
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, double-blind, placebo- and positive-controlled, stratified parallel group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: GuruNanda water-based non-whitening mouthwashNegative Control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult subjects aged 18-70, that are in good health.
- Subject must have:
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuruNanda natural Oil Pulling oral rinsetest product | Dietary supplement | Test Product |
| TheraBreath Plaque Control Oral Rinsenegative control | Dietary supplement | Positive Control |
| GuruNanda water-based non-whitening mouthwashnegative control | Dietary supplement | Negative Control |
Primary outcome
Modified Gingival Index (MGI)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
1 secondary outcome
Satisfaction Questionnaire
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GuruNanda natural Oil Pulling oral rinse and GuruNanda water-based non-whitening mouthwash in people with Good Health and Gingival Inflammation and Bleeding, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bennett T Amaechi, BDS, MS, PhD (210-567-3185, amaechi@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Gingival Index (MGI) (time frame: Baseline to 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.