| CTRI Number |
CTRI/2019/08/020646 [Registered on: 09/08/2019] Trial Registered Prospectively |
| Last Modified On: |
27/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate and compare the efficacy of sodium hypochlorite with turmeric oil and garlic oil in killing root canal microorganisms |
|
Scientific Title of Study
|
Antimicrobial efficacy of two commercially available essential oils as root canal irrigants in primary endodontic infection-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 |
Divyangana Madaan |
| Designation |
Post graduation student |
| Affiliation |
Sudha rustagi college of dental sciences and research |
| Address |
Room No. 7 PG section
Department of Conservative Dentistry and Endodontics
Sudha rustagi college of Dental Sciences and Research
Sec 89 kheri more
Faridabad Haryana
121002
Room No.7 PG section
Department of Conservative Dentistry and Endodontics
Sudha Rustagi College of Dental Sciences and Research sector 89 faridabad haryana 121002
Faridabad
HARYANA
121002
India |
| Phone |
9958285590 |
| Fax |
|
| Email |
diamadan1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Mittal |
| Designation |
Professor and Head of Department of Conservative Dentistry and Endodontics |
| Affiliation |
Sudha Rustagi College Of Dental Sciences and Research |
| Address |
Room No. 7 PG section
Department of Conservative Dentistry and Endodontics
Sudha Rustagi College of Dental Sciences and Research, Sector 89 Kheri more Faridabad, Haryana, 121002,India
Room No. 7 PG section
Department of Conservative Dentistry and Endodontics
Sudha Rustagi College of Dental Sciences and Research
Faridabad Haryana
121002
Faridabad
HARYANA
121002
India |
| Phone |
8708927230 |
| Fax |
|
| Email |
mttlrksh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divyangana Madaan |
| Designation |
Post Graduate Student |
| Affiliation |
Sudha Rustagi College Of Dental Sciences and Research |
| Address |
Room No. 7 PG Section
Department of Conservative Dentistry and Endodontics Sudha Rustagi College of Dental Sciences and Research, Sector 89 Kheri more Faridabad, Haryana, 121002,India
Room No. 7 PG Section
Department of Conservative Dentistry and Endodontics
Sudha Rustagi College of Dental Sciences and Research, Sec 89, Kheri More, Faridabad, Haryana 121002
Faridabad
HARYANA
121002
India |
| Phone |
8708927230 |
| Fax |
|
| Email |
diamadan1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 7 PG Section
Department of Conservative Dentistry and Endodontics Sudha Rustagi College of Dental Scienes and Research
Sector 89,Kheri more, faridabad, Haryana 121002 |
|
|
Primary Sponsor
|
| Name |
Divyangana Madaan |
| Address |
C-3/281 Janakpuri New Delhi 110058 |
| Type of Sponsor |
Other [Private dental college] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Divyangana Madaan |
Sudha rustagi college of dental sciences and research |
Department of conservative dentistry and endodontics
Sudha rustagi college of dental sciences and research sector 89 kheri more faridabad haryana 121002
Faridabad
HARYANA |
9958285590
diamadan1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Garlic oil
Turmeric oil |
Irrigation will me done with 5ml of respective irrigants in the root canal and samples will be collected using paperpoints before and after biomechanical preparation and bacterial count will be done |
| Comparator Agent |
sodium hypochlorite |
5ml as root canal irrigant and sample will be collected using paperpoints before and after biomechanical preparation and bacterial count will be done |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with non contributory medical history
Teeth with necrotic or infected pulp as diagnosed clinically and radiographically
Teeth with adequate coronal structure for proper isolation, temporization and restoration |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions
Pregnant patients
Acute periapical abscess
Retreatment cases
Patients on antibiotic therapy within three months
Teeth with calcified canals
Presence of extraoral or intraoral sinus
Immature apex
Internal or external resorption
Periodontal pockets more than 5mm |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the antimicrobial efficacy of turmeric oil, garlic oil and conventional irrigation in primary endodontic infections by estimated reduction of bacterial counts |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision in reduction of bacterial counts at two stages- Before biomechanical preparation- Sample 1 and After biomechanical preparation- Sample 2 |
45 minutes |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/01/2020 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of the present study was to in- vivo evaluate the antimicrobial efficacy of two commercially available essential oils, Turmeric oil and Garlic oil as root canal irrigants in primary endodontic infections and compare them with conventional irrigants i.e. 2.5% Sodium hypochlorite. In the present study, forty five patients with single rooted teeth were selected. After local anaesthetic administration and rubber dam placement, access cavity was made. Working length was determined using an apex locator and confirmed radiographically. Pretreatment sample (S1) was obtained with a paperpoint by injecting normal saline (5 ml) into the root canal & transporting it into the peptone water. Biomechanical preparation was done up to the working length with master apical file size #40 and step back up to size #60. The patients were randomly divided into three groups and irrigated with experimental solution; Group I: 2.5% Sodium Hypochlorite, Group II : Turmeric oil, Group III : Garlic oil. Post instrumentation & irrigation sample (S2) was collected in the same manner as S1. Microbiological samples (S1, S2) 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 of incubation using classic bacterial counting method. The results of this study demonstrated that in intergroup comparison, statistically significant reduction was found from S1 to S2 in all the three experimental groups. Whilst, in intergroup comparison the mean reduction of bacterial counts of Group- I (Sodium Hypochlorite) were found to be higher than that of Group- II (Turmeric Oil) & Group- III (Garlic Oil). However, the difference was not statistically significant when compared to Group- III (Garlic Oil) but the difference was statistically significant with Group- II (Turmeric Oil).
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