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Safety and Efficacy study GURUNANDA oil pulling oral rinse in reducing sensitivity in Patients with Sensitive tooth

A randomized, multi-centric, double blinded three arm, Placebo, and active Controlled parallel group comparative clinical trial to assess the efficacy and safety of Gurunanda Oil Pulling Oral Rinse in reducing the sensitivity of teeth and gums. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081110
Enrollment
90
Registered
2025-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified

Interventions

Intervention1: Gurunanda Oil Pulling Oral Rinse: Caprylic/Capric/Lauric Triglycerides, Peppermint Oil, Spearmint Oil, Clove Oil, Cardamom oil, Tea Tree Oil, Stevia Leaf Extract, , Oregano oil, Fennel

Sponsors

GuruNanda LLC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Presence of a minimum of 20 teeth 2.Presence of tooth sensitivity 3.Adequate oral hygiene and no sign of oral neglect 4.Qualifying response to the Air Blast Stimuli by Schiff Cold Air Sensitivity Scale 5.Use of a non-desensitizing dentifrice for one month prior to entry into the study

Exclusion criteria

Exclusion criteria: 1.Professional teeth cleaning and whitening less than 30 days before the examination. 2.Carrying out other dental procedures, including orthodontic and surgical, less than 30 days prior to the study. 3.The use of analgesic agents less than 7 days prior to inclusion 4.Untreated dental caries or active periodontal disease . 5.Presence of cracked, chipped, or fractured teeth. 6.Severe enamel loss, dentin exposure, or pulpitis 7.Teeth whitening, scaling, or polishing within the past 4 6 weeks. 8.Recent restorations or oral surgeries that could influence sensitivity. 9.Regular use of desensitizing toothpaste or treatments within the past 4 weeks 10.Use of prescription fluoride treatments or other dental products specifically targeting sensitivity 11.Conditions affecting oral health, such as diabetes, GERD. 12.Excessive consumption of acidic foods or beverages. 13.Heavy tobacco or alcohol use that could affect oral health or study results. 14.History of bruxism, clenching, or other habits that could increase tooth wear. 15.Known allergies to any components of the products being tested. 16.Conditions or medications that might interfere with the perception of sensitivity. 17.Participation in any other clinical study or test panel within one month prior to entry into the study. 18.History of Hepatitis B or C, HIV infection. 19.Chemotherapy, radiation therapy or cytokine therapy less than 5 years before being included in the study. 20.Pregnant or lactating participants.

Design outcomes

Primary

MeasureTime frame
1.Objective assessment of the sensitivity of hard tooth tissue, an index of the intensity of teeth hyperesthesia (IIGZ). 2.A visual analogue scale is proposed for self-assessment by the participant of the level of pain. 3.To evaluate the cleaning effect of studied products Oral Hygiene Index Simplified (OHI-S). 4.Air Blast Hypersensitivity. 5.Examiner rates the response to stimulation of hypersensitive teeth using a jet of air Response is rated based on the Schiff Cold Air Sensitivity Scale Response is rated based on the Schiff Cold Air Sensitivity Scale. 6.Reductions in extrinsic tooth stain area and extrinsic tooth stain intensity. 7.Photographic assessment of dental hygiene.Timepoint: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

Secondary

MeasureTime frame
1.Participant and Investigator Feedback will be obtained before enrollment and after completion of the study. 2.Adverse event monitoring.Timepoint: Visit 1(Day1), Visit 2(week1), visit 3(week2), visit 4(week3), visit 5(week4)

Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

KI3 PRIVATE LIMITED

saheerose@gmail.com9443627722

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026