MedPath

A Comparative Study of Herbal Mouthwash as Dispersible Tablets.

Not yet recruiting
Conditions
Healthy children aged 7–14 yrs without systemic issues, able to maintain oral hygiene, follow protocol, with cooperative, accepting parents or caregivers.
Registration Number
CTRI/2025/06/089832
Lead Sponsor
Dr Shrushti Thakare
Brief Summary

This randomized, double-blinded clinical trial aims to compare the efficacy of herbal mouthwash formulated as dispersible tablets containing Seabuckthorn and Jamun seed extracts with that of standard Chlorhexidine mouthwash tablets. The target population includes children aged 7 to 14 years. The primary objective is to assess and compare the reduction in plaque index among the groups. Secondary objectives include evaluating improvements in gingival health, patient acceptability of the herbal formulation, and recording any adverse effects. By exploring natural alternatives to Chlorhexidine, the study seeks to provide a safer, effective, and child-friendly option for maintaining oral hygiene and controlling dental plaque.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Children aged between 7-14 years Participants in good general health without systemic diseases or conditions affecting oral health.
  • Children who are able to comply with oral hygiene instructions and follow the study protocol.
  • Parents/caregivers acceptance and cooperation.
Exclusion Criteria
  • Presence of any oral pathology, such as gingival overgrowth or abscesses requiring urgent treatment.
  • Children with orthodontic appliances (e.g., braces or space maintainers) that could interfere with plaque assessment.
  • Systemic health conditions or medications that could influence oral hygiene or microbial flora (e.g., diabetes, immunosuppression).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period.The principal aim is to evaluate and compare the effectiveness of Seabuckthorn and Jamun Seed herbal mouthwash dispersible tablets with standard Chlorhexidine mouthwash tablets in reducing the plaque index in children aged 7–14 years over a specified period.
Secondary Outcome Measures
NameTimeMethod
Assessment of Gingival Health:Monitoring changes in gingival index or signs of gingival inflammation to assess any additional periodontal benefit.

Trial Locations

Locations (1)

NIMS Dental College

🇮🇳

Jaipur, RAJASTHAN, India

NIMS Dental College
🇮🇳Jaipur, RAJASTHAN, India
Dr Shrushti Raju Thakare
Principal investigator
09607668888
shrushtithakare31@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.