Oil Pulling Whitening Mouthwash

Official title

Evaluation of Tooth Whitening Efficacy of GuruNanda Oil Pulling Oral Rinse.

Overview

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.

Interventions

• Dietary supplement GuruNanda natural Oil Pulling oral rinse
  Test product
• Dietary supplement Therabreath Whitening Mouthwash - Dazzling Mint
  positive control
• Dietary supplement GuruNanda water-based non-whitening mouthwash
  negative control

Primary outcome measures

• Measurement by the VITA Easyshade Advance 4.0 [Time frame: Baseline to 8 weeks]
• VITA Bleachguide 3-D Master Shade Guide [Time frame: Baseline to 8 weeks]
• Lobene Stain Index [Time frame: Baseline to 8 weeks]

Secondary outcome measures (2)

• Satisfaction: Subjective participant questionnaires [Time frame: 8 weeks]
• Satisfaction Questionnaire [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• Clinical Research Facility of the Center for Oral Health and Research, UTHSA — San Antonio

Identifiers

NCT: NCT07667088 · STUDY00001211

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗