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Effect of Gurunanda Natural Oil Pulling Oral Rinse in improving oral hygiene

A randomized, multi-centric, single blinded three arm parallel group comparative clinical trial with CPC 0.07 percentage Anti-gingivitis/Antiplaque Oral Rinse and placebo to assess the efficacy and safety of GuruNanda Natural Oil Pulling Oral Rinse in maintaining and improving oral hygiene and periodontal health

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071303
Enrollment
60
Registered
2024-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: K036- Deposits [accretions] on teeth

Interventions

Intervention1: GuruNanda Natural Oil Pulling Oral Rinse (Coconut+ Mint): Caprylic/Capric/Lauric Triglycerides, Peppermint Oil, Spearmint Oil, Clove Oil, Tea Tree Oil, Cardamom oil, Oregano oil, Fennel

Sponsors

Gurunanda LLC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 . Systemically healthy adult subjects in the age group of 18-60 years who require oral hygiene support for maintaining or improving periodontal health and who agree to comply with the study procedures. 2. Subjects having gingival probing depth of less than 3mm. 3.Subjects having gingival index scores of equal to 2 and in more than 10 percent of the sites 4.Subjects with no history of hypersensitivity reactions. 5.Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 6. Subjects should not have history of periodontal therapy one 7.Subjects having plaque index scores of equal to 2 and in more than 10percent of the sites

Exclusion criteria

Exclusion criteria: 1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures; 2. Subjects with chronic or aggressive periodontitis; 3. Subjects with history of oral antibiotic prophylaxis within the past 1 month; 4.Tobacco consumers and smokers, 5.Subjects who are on any antibiotic therapy for the past 1 month and subjects with any other medical history that could compromise the conduct of the study 6.Subjects who are pregnant or lactating. 7.Subjects with previous history of any allergic reactions to the test products 8. Subjects participating in concomitant interventional clinical study during the previous 30 days.

Design outcomes

Primary

MeasureTime frame
1. Plaque Index (PI) and Modified Gingival Index (MGI) from baseline to end of study 2. To assess percentage mean reduction CFUs in cariogenic oral microflora (S.mutans) from baseline to end of study. 3. To assess percentage mean reduction CFUs in below species of gram positive from baseline to end of study. (Streptococcus mutans, Streptococcus sobrinus, Streptococcus anginosus, Lactobacillus spp) 4.To assess percentage mean reduction CFUs in fungus from baseline to end of study. 5.Effect of test product in reducing the Cavities 6.Effect of test product in reducing Halitosis 7.Effect of test product in reducing bleeding gums 8.To assess percentage mean reduction CFUs in below gram negative from baseline to end of study. (Porphyromonas gingivalis, Fusobacterium nucleatum,Prevotella intermedia) Timepoint: Baseline , Week 4 and Week 8

Secondary

MeasureTime frame
1.To assess improvement in Clinical Oral Dryness Score (CODS) from baseline to end of study. 2. To assess improvement in Organoleptic Scoring Scale (OSS) from baseline to end of study. 3.To assess improvement in VITA Shade Scale from baseline to end of study. 4.To assess the safety of test product throughout the study period by monitoring for any adverse events during the study period of 8 weeks.Timepoint: Baseline, week 4 and week 8

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