| CTRI Number |
CTRI/2021/09/036764 [Registered on: 23/09/2021] Trial Registered Retrospectively |
| Last Modified On: |
22/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
In vitro |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of the antibiofilm property of chitosan hydrogel loaded with catechin and chitosan hydrogel loaded with chlorhexidine. |
|
Scientific Title of Study
|
Comparative evaluation of the antibiofilm property of chitosan hydrogel loaded with catechin and chitosan hydrogel loaded with chlorhexidine. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ancy Esther Rose |
| Designation |
Postgraduate |
| Affiliation |
Sri Sankara Dental College |
| Address |
Sri Sankara Dental College, Akathumuri Varkala Trivandrum
Department of Periodontics
Thiruvananthapuram
KERALA
686673
India |
| Phone |
9496370882 |
| Fax |
|
| Email |
drancyestherrose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathew John |
| Designation |
Professor and HOD Dept. of Periodontics |
| Affiliation |
Sri Sankara Dental College |
| Address |
Sri Sankara Dental College, Varkala Trivandrum
Thiruvananthapuram
KERALA
686673
India |
| Phone |
9633860400 |
| Fax |
|
| Email |
drmathewj1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ancy Esther Rose |
| Designation |
Postgraduate |
| Affiliation |
Sri Sankara Dental College |
| Address |
Sri Sankara Dental College Akathumuri Varkala Trivandrum
Department of Periodontics
Thiruvananthapuram
KERALA
686673
India |
| Phone |
9496370882 |
| Fax |
|
| Email |
drancyestherrose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Pushpagiri Institute of Medical Sciences and Research Centre |
| Address |
Pushpagiri Institute of Medical Sciences and Research Centre Thiruvalla |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mathew John |
Pushpagiri institute of medical science and research center |
Department of Periodontics and Lab in Pushpagiri, Thiruvalla
Pathanamthitta
KERALA |
9048547346
drmathewj1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sankara Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Periodontitis |
| Patients |
, (1) ICD-10 Condition: R688||Other general symptoms and signs, (2) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged between 25-50 years with periodontitis.
Pocket depth less than or equal to 4-5mm |
|
| ExclusionCriteria |
| Details |
Patient without periodontitis
Patient with systemic disease
Hospitalized patient or patient under medication for any other disease |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Biofilm biomass quantification
Qualitative estimation
|
24hrs till every 5th day
72hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degradation Rate |
1st, 2nd,3rd,4th week |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. |