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A study to Evaluate how effective and safe Cardamom Herbal Toothpaste and Mouthwash are for treating periodontitis by analyzing changes in salivary biomarkers.

Evaluating the Efficacy and Safety of Recoverees Cardamom Herbal Toothpaste and Recoverees Cardamom Herbal Mouthwash Containing Cardamom Bio-actives in periodontitis Patient through Quantitative Analysis of Salivary Biomarkers . - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072800
Enrollment
60
Registered
2024-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: K054- Periodontosis

Interventions

Intervention1: Cardamom Mouthwash and Toothpaste: Cardamom Mouthwash and Toothpaste twice a daily for 2weeks Control Intervention1: Nil: Nil

Sponsors

M/S Zum Heilen Diagnostic and Therapeutic Private Limited (ZHDAT)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects diagnosed with Stage I & II periodontitis as per the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. (Subjects with probing pocket depth less than 5 mm & clinical attachment loss less than 4 mm and aged between 20-65years.) 2. Subjects who have not undergone any sort of periodontal therapy in the past six months 3. Ability to comprehend study procedures and provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of systemic diseases affecting periodontal health (e.g., uncontrolled diabetes, immunodeficiency disorders). 2. Patients with a history of antibiotic or antimicrobial therapy within the past 3 months. 3. Patients with known allergies to cardamom. 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
The primary outcomes are the changes in salivary levels of inflammatory biomarkers (IL-6, TNF-a, NF-KappaB) and microbial biomarkers (Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola) from baseline to the end of the study.Timepoint: Baseline and day 14.

Secondary

MeasureTime frame
Secondary outcomes are the changes in clinical parameters (probing depth, clinical attachment level, bleeding on probing).Timepoint: Baseline and day 14.

Countries

India

Contacts

Public ContactDr Prashanth Varkey

Pharexcel Consulting Pvt Ltd.

info@pharexcelconsulting.com9878551428

Outcome results

None listed

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