ClinicalTrials.gg
RecruitingNCT07667088Updated Jun 24, 2026

Oil Pulling Whitening Mouthwash

An interventional study of GuruNanda natural Oil Pulling oral rinse and Therabreath Whitening Mouthwash - Dazzling Mint in Healthy Adult Participants and Tooth Stain, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Tooth Discoloration with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Tooth Discoloration · United States.

Planned enrollment
4th of 13
120 · median 91
Started
2026
with 2 others
No phase
12 of 13
3 open now
Registered
10th of 13
by date
Lead sponsor
1 of 13
The University of Texas Health Science Center at San Antonio

Among the 13 studies in Tooth Discoloration with a site in United States, this one is the 4th largest by planned enrollment, is one of 3 that started in 2026, is one of 12 with no phase, and was the 10th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phasethis study12 · 3 open
Phase 21 · 0 open

By the year they started

First in 2006; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 91 across the 13 interventional studies. Of the 10 that completed or were terminated, 1 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Tooth Discoloration with a site in United States, or all of them as a file.
02

Study 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). 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.

03

Conditions studied

  • Healthy Adult Participants
  • Tooth Stain

Browse trials for

Keywords

  • tooth whitening
  • tooth stains
  • oil pulling
  • mouthwash
  • mouth rinse
  • stain removal
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult subjects aged 18-60, that are in good health.
  2. 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.
  3. 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.
  4. Subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Form.
  5. 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.
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or nursing by subject report.
  2. 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).
  3. Any active condition in the oral cavity at the discretion of the investigator.
  4. Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.
  5. Subjects that do not brush regularly.
  6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
  7. Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
  8. Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
  9. Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
  10. Participation in another clinical trial within the last 30 days.
  11. Presence of orthodontic appliances, except for removable retainers.
  12. Signs of advanced enamel wear, dentin exposure, or tooth fractures.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Test Product

    Dietary Supplement: GuruNanda natural Oil Pulling oral rinse

  • Active comparator
    Positive Control

    Dietary Supplement: Therabreath Whitening Mouthwash - Dazzling Mint

  • Placebo comparator
    Negative Control

    Dietary Supplement: GuruNanda water-based non-whitening mouthwash

Interventions

  • Dietary supplementGuruNanda natural Oil Pulling oral rinse

    Test product

  • Dietary supplementTherabreath Whitening Mouthwash - Dazzling Mint

    positive control

  • Dietary supplementGuruNanda water-based non-whitening mouthwash

    negative control

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline to 8 weeks

  2. 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.

    Time frame: Baseline to 8 weeks

  3. 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.

    Time frame: Baseline to 8 weeks

Secondary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Aug 2026, 3 months after the start.

Of 44 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 3 months is below that.

Counting every sponsor, half of 52 studies reached it within 8 months; a quarter within 2 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jun 24, 2026
StartActual
May 1, 2026
Primary completionEst.
Aug 31, 2026
CompletionEst.
Aug 31, 2026
Last update
Jun 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07667088
Collaborators
GuruNanda LLC
Responsible party
Bennett Amaechi (Professor and Director of Cariology, Department of Comprehensive Dentistry, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
Jun 24, 2026
Start date
May 1, 2026
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Jun 24, 2026

Study contacts

Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
Contact
amaechi@uthscsa.edu
210-567-3185
Razina Vohra
Contact
vohrar@uthscsa.edu
210-643-9803

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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