| CTRI Number |
CTRI/2019/12/022399 [Registered on: 17/12/2019] Trial Registered Prospectively |
| Last Modified On: |
30/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
ANTIMICROBIAL EFFECTIVENESS OF DIFFERENT IRRIGATING SOLUTIONS IN ROOT CANAL SYSTEM |
|
Scientific Title of Study
|
“COMPARATIVE EVALUATION OF ANTIMICROBIAL EFFECTIVENESS OF SODIUM HYPOCHLORITE ,CALCIUM HYPOCHLORITE AND MORINDA CITRIFOLIA AGAINST MICROORGANISMS PRESENT IN THE ROOT CANAL SYSTEM†: A RANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANITH KUMAR CHAKILELA |
| Designation |
PG STUDENT |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Conservative dentistry and Endodontics,
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally
Nalgonda,Telangana.
Nalgonda TELANGANA 508254 India |
| Phone |
9573130353 |
| Fax |
|
| Email |
anithget2me@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR S JAYAPRADA REDDY |
| Designation |
PROFFESOR |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Conservative dentistry and Endodontics,
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally
Nalgonda TELANGANA 508254 India |
| Phone |
9703936020 |
| Fax |
|
| Email |
drsjayapradareddy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR S JAYAPRADA REDDY |
| Designation |
PROFFESOR |
| Affiliation |
KAMINENI INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Conservative dentistry and Endodontics,
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally
Medchal TELANGANA 508254 India |
| Phone |
9703936020 |
| Fax |
|
| Email |
drsjayapradareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kamineni institute of dental sciences.Narketpally,nalgonda |
|
|
Primary Sponsor
|
| Name |
DR CH ANITH KUMAR |
| Address |
Department of Conservative dentistry and Endodontics,
Kamineni Institute of Dental Sciences,
Sreepuram, Narketpally
Nalgonda, Telangana.
|
| Type of Sponsor |
Research institution |
|
|
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 Ch Anith Kumar |
Kamineni institute of dental sciences. |
Room no 121 , Department of conservative dentistry and endodontics, narketpally, nalgonda. Nalgonda TELANGANA |
9573130353
anithget2me@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, KIDS , Narketpally |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
In need of root canal therapy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium hypochlorite |
10 ml Calcium hypochlorite in root canal for 60 seconds |
| Comparator Agent |
Morinda citrifolia |
10ml of Morinda citrifolia in rootcanal for 60 seconds |
| Intervention |
Sodium hypochlorite |
10ml Sodium hypochlorite in rootcanal for 60 sec |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18-55 years
2.Teeth with necrotic pulp.
3.Patient requiring endodontic therapy.
4.Healthy patients without systemic disease.
5.Teeth with asymptomatic/symptomatic apical periodontitis.
|
|
| ExclusionCriteria |
| Details |
1.Crown and root fracture.
2.Grossly decayed tooth.
3.Vital teeth.
4.Medically compromised patients.
5.Para functional habits.
6.Non carious lesions.
7.TMJ disorders
8.Patients on antibiotic therapy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial effectiveness |
Pre treatment and Post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulp dissolution |
Pre treatment and Post treatment |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2019 |
| Date of Study Completion (India) |
03/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The
successful outcome of endodontic treatment depends on through disinfection.
Based on this concept, the ultimate goal of endodontic therapy is to eliminate
or remarkably minimize the microbes and their toxic products from the root
canal before obturation.
However
the complex morphology of root canal system, invasion of microbes into the
dentinal tubules, and formation of smear layer during instrumentation are the
major obstacles in achieving complete cleaning and shaping of the root
canals.The role of mechanical instrumentation alone in removing microbes from
the root canals has been investigated in many studies, and majority of them
have found a significant reduction in the microbial count with an increasing
preparation size and irrigation However, Peter and Wesselink found that more
than 35% of root canal walls remained untouched even by modern rotary Ni‑Ti
instrumentation techniques.
Sodium hypochlorite is the gold standard and the
most effective irrigating solution but owing to the potential side effects,
constant increase in antibiotic strains, safety concerns and cytotoxic
reactions there is a need for an alternative.
Calcium hypochlorite is antimicrobial, relatively
more stable, higher available chlorine ion percentage and induces minimal
inflammatory response when compared to Sodium hypochlorite.
Due to increased cytotoxic reactions of synthetic
irrigants, usage of various herbal agents has increased over the last few
decades.
Morindacitrifolia juice
(MCJ) commercially known as Noni juice exhibits antiviral, antifungal,
antihelminthic, antitumor, anti-inflammatory, analgesic,hypotensive, and
immune-enhancing effect suggesting its potential to be used as an endodontic
irrigant. |