| CTRI Number |
CTRI/2017/05/008474 [Registered on: 03/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the effectiveness of two agents with infection reducing properties |
|
Scientific Title of Study
|
comparitive evaluation of antibacterial efficacy of silver nanoparticles and calcium hydroxide as intracanal medicament-a randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nelapati Haritha |
| Designation |
post graduate student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics
Narayana Dental College and Hospital Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
8500534206 |
| Fax |
|
| Email |
harithanelapati1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anumula Lavanya MDS |
| Designation |
Reader |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics
Narayana Dental College and Hospital Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9346567413 |
| Fax |
|
| Email |
lavanyamds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nelapati Haritha |
| Designation |
post graduate student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of conservative dentistry and endodontics
Narayana Dental College and Hospital Chintareddypalem
Nellore
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
8500534206 |
| Fax |
|
| Email |
harithanelapati1990@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endodontics Department .no. 4, 1st floor,
Narayana Dental College and Hospital Chintareddypalem
Nellore
|
|
|
Primary Sponsor
|
| Name |
Narayana dental college and hospital |
| Address |
First floor, room no.4 Depatment of conservative dentistry
and endodontics Narayana Dental College and Hospital
Nellore
|
| Type of Sponsor |
Other [private dental college and hospitals] |
|
|
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 |
| Nelapati Haritha |
Narayana dental college and hospital |
First floor, room no.4 Depatment of conservative dentistry
and endodontics Narayana Dental College and Hospital
Nellore
Nellore
ANDHRA PRADESH |
8500534206
harithanelapati1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asymptomatic irreversible pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium hydroxide |
Freshly mixed calcium hydroxide paste is carried in to the root canals by using lentulospirals and retained for 7days. |
| Intervention |
Silver nanoparticles |
0.01% of silver nanoparticle gel is delivered by means of syringe into the root canals and retained for 7days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
single rooted teeth
single canal
fully formed root |
|
| ExclusionCriteria |
| Details |
multiple roots
multiple rootcanals
immature/open apices |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| decrease in the microbial load in the root canals |
1week after medicament placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in the microbial load in the root canals |
1week after medicament placement |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
This study has not been published yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized double blind parallel group single-centre trial comparing the antimicrobial efficacy of calcium hydroxide and silver nanoparticles as intracanal medicament for 7days in 40 patients with intracanal infection that will be conducted in Narayana Dental College and Hospital, India. The primary outcome measures will be done by microbiological growth assessment 1week after incubating the cultures after the medicament placement. |