Healthy Adult ParticipantsNCT07667088
Oil Pulling Whitening Mouthwash
A study testing GuruNanda natural Oil Pulling oral rinse, Therabreath Whitening Mouthwash - Dazzling Mint and GuruNanda water-based non-whitening mouthwash in people with Healthy Adult Participants and Tooth Stain, 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 evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Healthy Adult Participants, Tooth Stain
- What is being tested?
- GuruNanda natural Oil Pulling oral rinse, Therabreath Whitening Mouthwash - Dazzling Mint 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
- 1 May 2026to 31 Aug 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult subjects aged 18-60, that are in good health.
- Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.
- Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.
- 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, and will refrain from using any other teeth whitening technologies during this period.
- The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.
Who cannot join
- Pregnant or nursing by subject report.
- Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery or dental procedure in the treated area 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 the study, at the discretion of the investigator.
Show all 12Show fewer
- Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
- Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
- Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
- Participation in another clinical trial within the last 30 days.
- Presence of orthodontic appliances, except for removable retainers.
- Signs of advanced enamel wear, dentin exposure, or tooth fractures.
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, MFDS RCPS, FADI, 210-567-3185, amaechi@uthscsa.edu
Razina Vohra, 210-643-9803, vohrar@uthscsa.edu
About this study
Official title: Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.
The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). All mouthwashes will be used once daily last thing before bed at night. Data will be collected on tooth shade evaluated on the anterior teeth.
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 tooth shade measured using the VITA Easy Shade Advance Spectrophotometer. Males and females aged between 18 and 60 years will be enrolled. 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 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. 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 tooth shade evaluated using the Lobene Stain Index, VITA Bleachedguide 3D-Master shade guide and the Vita EasyShade® Advance 4.0 Spectrophotometer on the anterior teeth. The average summary scores will be calculated for each group on each of these measurements. 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.
- Conditions
- Healthy Adult Participants, Tooth Stain
- Being tested
- GuruNanda natural Oil Pulling oral rinse, Therabreath Whitening Mouthwash - Dazzling Mint, GuruNanda water-based non-whitening mouthwash
- Keywords
- tooth whitening, tooth stains, oil pulling, mouthwash, mouth rinse, stain removal
- Medical subject headings
- Tooth Discoloration
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 Whitening Mouthwash - Dazzling MintDietary supplement
positive 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 Whitening Mouthwash - Dazzling Mint |
| Negative Control | Placebo comparator | Not described 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.
Measurement by the VITA Easyshade Advance 4.0
A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade
Measured: Baseline to 8 weeks
VITA Bleachguide 3-D Master Shade Guide
A single examiner will perform visual tooth shade assessment under standard lighting conditions. Tooth shade will be scored on selected anterior teeth . The tab marking system includes interpolated shade guide units (sgu) ranging from 1 to 29 sgu with a lower score indicating more whitening. Subject shade rank scores will be determined for each visit by calculating the mean value across the selected anterior teeth scored.
Measured: Baseline to 8 weeks
Lobene Stain Index
Measure of intensity and extent of extrinsic stain on the facial surfaces of 12 anterior teeth. The teeth are divided into regions which are scored separately. Intensity is scored from 0 (no stain) to 3 (heavy stain; dark brown to black) and extent is scored from 0 (no stain) to 3 (stain covering over two-thirds of the region). Scores will be averaged for each subject for intensity (sum of all intensity scores/all sites graded) and extent (sum of all extent scores/all sites graded), and the composite stain score calculated by multiplying the mean stain intensity by the mean stain extent.
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Satisfaction: Subjective participant questionnaires
Front teeth appearance: Five subjects will be selected from each study group for this purpose. A digital imaging system, camera (Canon EOS 50D), will be used. The camera (Canon EOS 50D) is to be attached to a standardized head positioner to allow for consistency between images. A digital exposure will be made with include lips/cheeks retracted and anterior teeth aligned edge to edge. Another digital exposure will also be made with the subjects smiling but covering just the area between nose and chin. Photographs will be taken as digital images before the treatment and at the final study visit when efficacy assessments are completed. Lighting conditions will be as described for the tooth shade assessments to ensure uniformity among subjects and consistency across time.
Measured: 8 weeks
Satisfaction Questionnaire
A questionnaire containing 6 scorable items with a potential score of (a) 5=Very High to (e)1=Very Low and 4 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 posted24 Jun 2026
- Study start1 May 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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 double-blind, randomized, placebo-and positive-controlled, stratified parallel group prospective clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT07667088
- Sponsor's protocol ID
- STUDY00001211
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.
- ClinicalTrials.gov ID
- NCT07667088
- Acronym / sponsor ID
- STUDY00001211
- Conditions
- Healthy Adult Participants, Tooth Stain
- Keywords
- tooth whitening, tooth stains, oil pulling, mouthwash, mouth rinse, stain removal
- 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
- 1 May 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Jun 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 evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). All mouthwashes will be used once daily last thing before bed at night. Data will be collected on tooth shade evaluated on the anterior teeth.
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 tooth shade measured using the VITA Easy Shade Advance Spectrophotometer. Males and females aged between 18 and 60 years will be enrolled. 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 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. 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 tooth shade evaluated using the Lobene Stain Index, VITA Bleachedguide 3D-Master shade guide and the Vita EasyShade® Advance 4.0 Spectrophotometer on the anterior teeth. The average summary scores will be calculated for each group on each of these measurements. 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
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group prospective clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Dietary Supplement: GuruNanda natural Oil Pulling oral rinse |
| Positive Control | Active comparator | Dietary Supplement: Therabreath Whitening Mouthwash - Dazzling Mint |
| Negative Control | Placebo comparator | Dietary Supplement: GuruNanda water-based non-whitening mouthwash |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adult subjects aged 18-60, that are in good health.
- Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.
- Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.
- 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, and will refrain from using any other teeth whitening technologies during this period.
Key exclusion criteria (12 listed)
- Pregnant or nursing by subject report.
- Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).
- Any active condition in the oral cavity at the discretion of the investigator.
- Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.
- Subjects that do not brush regularly.
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 Whitening Mouthwash - Dazzling Mintpositive control | Dietary supplement | Positive Control |
| GuruNanda water-based non-whitening mouthwashnegative control | Dietary supplement | Negative Control |
Primary outcome
Measurement by the VITA Easyshade Advance 4.0
Time frame: Baseline to 8 weeks
A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade
VITA Bleachguide 3-D Master Shade Guide
Time frame: Baseline to 8 weeks
A single examiner will perform visual tooth shade assessment under standard lighting conditions. Tooth shade will be scored on selected anterior teeth . The tab marking system includes interpolated shade guide units (sgu) ranging from 1 to 29 sgu with a lower score indicating more whitening. Subject shade rank scores will be determined for each visit by calculating the mean value across the selected anterior teeth scored.
Lobene Stain Index
Time frame: Baseline to 8 weeks
Measure of intensity and extent of extrinsic stain on the facial surfaces of 12 anterior teeth. The teeth are divided into regions which are scored separately. Intensity is scored from 0 (no stain) to 3 (heavy stain; dark brown to black) and extent is scored from 0 (no stain) to 3 (stain covering over two-thirds of the region). Scores will be averaged for each subject for intensity (sum of all intensity scores/all sites graded) and extent (sum of all extent scores/all sites graded), and the composite stain score calculated by multiplying the mean stain intensity by the mean stain extent.
2 secondary outcomes
Satisfaction: Subjective participant questionnaires
Time frame: 8 weeks
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 Jun 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, Therabreath Whitening Mouthwash - Dazzling Mint and GuruNanda water-based non-whitening mouthwash in people with Healthy Adult Participants and Tooth Stain, 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 6 inclusion and 12 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 Jun 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, MFDS RCPS, FADI (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?
Measurement by the VITA Easyshade Advance 4.0 (time frame: Baseline to 8 weeks). The study lists 3 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 Jun 2026.