CTRI Number |
CTRI/2018/07/014743 [Registered on: 05/07/2018] Trial Registered Retrospectively |
Last Modified On: |
04/07/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To determine the efficacy of Calcium Hydroxide And Silver Nanoparticles against miroorganisms during root canal treatment |
Scientific Title of Study
|
Comparative Evaluation Of Antimicrobial Activity Of Calcium Hydroxide And Silver Nanoparticles as Intracanal Medicament - An In vivo Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Aditi Kohli |
Designation |
PG student |
Affiliation |
Sudha Rustagi Dental College |
Address |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics,
Sudha Rustagi Dental College, Faridabad
Faridabad HARYANA 121002 India |
Phone |
9711220258 |
Fax |
|
Email |
aditikohli321@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Monika Tandan |
Designation |
Professor |
Affiliation |
Sudha Rustagi Dental College |
Address |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics,
Sudha Rustagi Dental College, Faridabad
Faridabad HARYANA 121002 India |
Phone |
9999063631 |
Fax |
|
Email |
drmonikatandan@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Aditi Kohli |
Designation |
Post Graduate Student |
Affiliation |
Sudha Rustagi Dental College |
Address |
Room no. 7, 2nd floor, Department of Conservative Dentistry and Endodontics,
Sudha Rustagi Dental College, Faridabad
Faridabad HARYANA 121002 India |
Phone |
9711220258 |
Fax |
|
Email |
aditikohli321@gmail.com |
|
Source of Monetary or Material Support
|
Sudha Rustagi Dental College,sector 89, kheri More, Faridabad |
|
Primary Sponsor
|
Name |
Sudha Rustagi Dental College |
Address |
Sector 29, Kheri More, Faridabad, Haryana |
Type of Sponsor |
Other [Private Dental College] |
|
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 |
Rakesh Kumar |
Sudha rustagi dental college |
Room no. 7, 2nd floor, Department of conservative dentistry and endodontics, Sudha rustagi dental college Faridabad HARYANA |
9813172742
mttlrksh@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, SRCDSR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Healthy patients, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
calcium hydroxide powder |
40 mg Calcium hydroxide powder was mixed with a drops of propylene glycol and applied to the root canal walls with lenturospiral and kept in the canal for 7 days. |
Intervention |
intracanal medicament |
it was used to disinfect the root canals in between appointments. |
Comparator Agent |
Silver Nanoparticle dispersion, Nano Labs, India |
Silver Nanoparticle dispersion was applied with paper point soaked in it and placed into the root canal for 7 days. |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Patients with non-contributory medical history, intact permanent teeth without any previous restoration, with a necrotic or infected pulp as diagnosed clinically and radiographically, with adequate coronal structure for proper isolation, temporization, and restoration were included |
|
ExclusionCriteria |
Details |
Patients with systemic conditions, acute periapical abscess,retreatment cases, patients on antibiotic therapy within three months, teeth with calcified canals, sinus opening, immature apex, internal or external resorption or periodontal pockets>5mm and pregnant women were excluded |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in bacterial counts |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Colony counts in different groups at stages S1, S2 and S3 |
6 months |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
02/11/2016 |
Date of Study Completion (India) |
23/06/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
30/06/2017 |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The aim of the present study was to compare and evaluate the antibacterial efficacy of
calcium hydroxide paste and silver nanoparticles in vivo. In the present study, thirty patients with thirty single rooted teeth were selected.
Patients with non-contributory medical history, intact permanent teeth without any
previous restoration, with a necrotic or infected pulp as diagnosed clinically and
radiographically, with adequate coronal structure for proper isolation, temporization,
and restoration will be included. After local anaesthesia administration and rubber
dam placement access opening was made and sample S1 was taken (three samples)
with paper point after injecting 5 ml normal saline solution. After working length
determination and biomechanical preparation till size #40 K-file, post instrumentation
sample S2 was collected in the same manner as S1. Then, it was sent to laboratory for
processing within 2 hours. After second sampling, the canals were dried and
medicaments were applied randomly among 30 patients (15 patients each) with
lentulospiral and left in place for 7 days. After 7 days, following medicament removal, sample S3 was taken. Microbiological samples (S1, S2, S3) were
preincubated for 30 minutes and shaken vigorously in a vortex mixture for 60
seconds and then were plated on Brain heart infusion agar and colonies were
counted after 24 hours using classic bacterial counting method. The results showed that there was significant reduction of bacterial count from stages
S1 (after access opening) to S2 (after biomechanical preparation), and S3 (after
medicament placement) in both the experimental groups (intracanal medicaments).
The percentage reduction was better with Group 2 (silver nanoparticles), however, it
was not statistically significant when compared to Group 1 (Calcium hydroxide). Within the limitations of this study, it can be concluded that silver nanoparticles
showed significant antimicrobial activity and can be used as an effective root canal
medicament as an alternative to calcium hydroxide dressing. |