Comparative evaluation of the antibiofilm property of chitosan hydrogel loaded with catechin and chitosan hydrogel loaded with chlorhexidine.

Phase 1/2

• Conditions: Periodontitis; Other general symptoms and signs, (2) ICD-10 Condition: A488||Other specified bacterial diseases,

• Registration Number: CTRI/2021/09/036764
• Lead Sponsor: Pushpagiri Institute of Medical Sciences and Research Centre

Brief Summary

This study is intended to compare between natural and conventionally used materials incorporated in the study group to obtain an oral mucosal delivery agent with antibiofilm efficacy and sustained release property against Streptococcus mutants and Enterococcus faecalis. Three study groups are chitosan hydrogel, chitosan hydrogel loaded with catechin and chitosan hydrogen loaded with chlorhexidine. Biofilm inhibition study is based on prevention of biofilm and biofilm irradication study is based on treatment and intervention therapy. Qualitative analysis of biofilm is carried out using CV staining and SEM. Quantitative analysis of biofilm is carried out using Spectrophotometric analysis. Biofilm linked bacterial enumeration is calculated using colony counter. FTIR is used to assess the morphological characterization of study  groups. Degradation rate is assessed by calculating the weight remaining in the study groups when treated with simulated body fluid and when dried.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-09-22
• Study Start: 2021-09-23

Recruitment & Eligibility

• Status: Not Applicable
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patient aged between 25-50 years with periodontitis.
• Pocket depth less than or equal to 4-5mm.

Exclusion Criteria

Patient without periodontitis Patient with systemic disease Hospitalized patient or patient under medication for any other disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biofilm biomass quantification	24hrs till every 5th day | 72hrs
Qualitative estimation	24hrs till every 5th day | 72hrs

Secondary Outcome Measures

Name	Time	Method
Degradation Rate	1st, 2nd,3rd,4th week

Trial Locations

Locations (1)

Pushpagiri institute of medical science and research center; 🇮🇳 Pathanamthitta, KERALA, India

Pushpagiri institute of medical science and research center

🇮🇳Pathanamthitta, KERALA, India

Dr Mathew John

Principal investigator

9048547346

drmathewj1@gmail.com