A clinical study to understand efficacy and safety of new mouthwash in adults

A single blind, single centric, randomized 3 arm parallel study to demonstrate the efficacy and tolerability of Gurunanda Natural Oil Pulling Oral Rinse in the management of Gum Health and Gingivitis when compared to CPC (comparator) based mouthwashand Placebo.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068543

Enrollment

Registered

2024-06-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: B954- Other streptococcus as the cause of diseases classified elsewhere

Interventions

Intervention1: Gurunanda Natural Oil Pulling Oral Rinse: 10 ml of Gurunanda Natural Oil Pulling Oral Rinse administered orally once a day for 8 weeks Control Intervention1: CPC: 20 ml of CPC Oral Rins

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult male or female subjects (age 18-60yrs) 2.Subjects with at least 24 teeth. 3.Subjects having gingival probing depth of less than 3mm. 4.Subjects having gingival index scores equal to 2 and in more than 10% of the sites. 5.Subjects having plaque index scores equals to 2 and in more than 10% of the sites. 6.Subjects with no history of hypersensitivity reactions. 7. Able to communicate adequately with the investigator and to comply with the requirements for the entire study. 8. Subjects should not have history of periodontal therapy one month prior to screening. 9. Patient should be able to give written informed consent prior to participating in the study.

Exclusion criteria

Exclusion criteria: Subjects who have used antibiotics, antimicrobials, steroidal anti- inflammatory drugs, desensitizing toothpaste and NSAIDs within one month prior to screening. 2. Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, psychiatric diseases, blood disorders, gastrointestinal diseases). 3. Subjects with systemic conditions like diabetes, gastritis; oral diseases such as advanced periodontitis, frank dental caries, mucosal lesions. 4. Subjects with history of smoking or chewing tobacco. 5. Subjects with orthodontic appliances. 6. Hypersensitivity to any components of the investigational product. 7. Pregnancy and breastfeeding women. 8. Participation in concomitant interventional clinical study during the previous 30 days.

Design outcomes

Primary

Measure	Time frame
1. Reduction of Modified gingival Index. 2. Reduction of Plaque Index.Timepoint: Screening week 4, 8	—

Secondary

Measure	Time frame
1.Reduction of cariogenic oral microflora. 2.In achieveing a significant reduction in CFUs in gram positive. 3.In achieveing a significant reduction in CFUs in gram negative. 4.Improvement of clinical oral dryness score (CODS). 5.Enhancement of organoleptic scoring scale (OSS). 6.Improvement VITA shade scale. 7.Compliance and tolerability. 8.Overall treatment satisfaction questionnaire.Timepoint: Baseline week 4, 8	—

Measure

Time frame

1.Reduction of cariogenic oral microflora. 2.In achieveing a significant reduction in CFUs in gram positive. 3.In achieveing a significant reduction in CFUs in gram negative. 4.Improvement of clinical oral dryness score (CODS). 5.Enhancement of organoleptic scoring scale (OSS). 6.Improvement VITA shade scale. 7.Compliance and tolerability. 8.Overall treatment satisfaction questionnaire.Timepoint: Baseline week 4, 8

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Countries

India

Contacts

Public ContactDr Deepa Subramanian

Syncretic Clinical Research Services Pvt. Ltd.

deepa@syncretic.in9972598010

Outcome results

None listed

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