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

Gurunanda LLC4 sites in 1 country60 target enrollmentStarted: August 7, 2024Last updated: July 23, 2024

Overview

Phase: Phase 3
Status: Completed
Sponsor: Gurunanda LLC
Enrollment: 60
Locations: 4
Primary Endpoint: 1. Plaque Index (PI) and Modified Gingival Index (MGI) from

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

60 adults requiring oral hygiene support for maintaining or to improve periodontal health will be enrolled in the study. All the study subjects will receive a set of toothbrush and toothpastes from same manufacturer to overcome the confounding bias.

The study subjects will be asked to self-administer the test product 10 ml into their mouth for 2 minutes and will be asked to spit out the content and rinse with normal water once daily in the morning for test & placebo , 10 ml daily in the morning followed by brushing for 8 weeks

Group 1- Gurunanda Natural Oil Pulling oral RInse

Group 2- CPC 0.07% anti gingivitis/ Antiplaque oral rinse

Group 3- Placebo

Primary Outcome 1) To assess the effect of test Product on OHI, PI and MGI from baseline and end of the study 2) To assess % mean reduction in cariogenic oral microflora from baseline to end of the study 3) To assess % mean reduction CFU in gram positive bacteria 4) TO assess % mean reduction CFU in gram negative bacteria 5) To assess % mean reduction CFU in fungus 6) Effect of test in reducing Cavities 7) Effect of test Product in reducing Halitosis 8) Effect of test product in reducing bleeding gums

Study Design

Study Type: Interventional
Allocation: Randomized
Masking: Participant Blinded

Eligibility Criteria

Ages: 18.00 Year(s) to 60.00 Year(s) (—)
Sex: All

Inclusion Criteria

•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.
•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.
•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

•1.Subjects with mal-aligned teeth, wearing orthodontic appliances and removable partial dentures;
•Subjects with chronic or aggressive periodontitis;
•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.