| CTRI Number |
CTRI/2024/05/067273 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of ability of two herbal products used for cleaning root canals in tooth infections. |
|
Scientific Title of Study
|
Evaluation of anti microbial efficacy of two herbal products used as irrigants in primary endodontic infections in single rooted teeth - A Randomised Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R BOOBALAN |
| Designation |
Junior Resident (M.D.S,) |
| Affiliation |
Government Dental College Kottayam |
| Address |
Room.no.401
Department of Conservative Dentistry And Endodontics
Government Dental College
Gandhinagar P.O.
Kottayam
Kottayam KERALA 686008 India |
| Phone |
9884840017 |
| Fax |
|
| Email |
alanbrave05@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SHEENA P |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College Kottayam |
| Address |
Room no.401
Department of Conservative Dentistry And Endodontics
Government Dental College
Gandhinagar P.O.
Kottayam
Kottayam KERALA 686008 India |
| Phone |
9847632380 |
| Fax |
|
| Email |
sheenababu.p@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
R BOOBALAN |
| Designation |
Junior Resident (M.D.S,) |
| Affiliation |
Government Dental College Kottayam |
| Address |
Room no.401
Department of Conservative Dentistry And Endodontics
Government dental college
Gandhinagar P.O.
Kottayam
Kottayam KERALA 686008 India |
| Phone |
9884840017 |
| Fax |
|
| Email |
alanbrave05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental Kottayam
Room no.401
Department of Conservative Dentistry and Endodontics
Gandhinagar P.O.
Kottayam |
|
|
Primary Sponsor
|
| Name |
R BOOBALAN |
| Address |
Room no.401
Department of Conservative Dentistry And Endodontics
Government Dental College
Gandhinagar P.O
Kottayam. |
| Type of Sponsor |
Other [Self] |
|
|
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 R BOOBALAN |
Government Dental College, Kottayam |
Room no.401
Department of Conservative Dentistry And Endodontics
Gandhinagar P.O
Kottayam 686008 Kottayam KERALA |
9884840017
alanbrave05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Institutional Ethics Committee (IEC)/Institutional Review Board (IRB) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2% Chlorhexidine Gluconate |
Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. Irrigation will be done with 6 mL 2% Chlorhexidine Gluconate. |
| Intervention |
Neem Juice extract(Azadirachta indica)and Moringa Juice Extract(Moringa olifera). |
Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. Irrigation will be done with 6 mL Neem Juice extract (Azadirachta indica). |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with necrotic or infected pulp diagnosed clinically and radiographically
Teeth with an adequate coronal structure. |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions, acute periapical abscess, retreatment cases, root fractures
Teeth with calcified canals, sinus opening in mature apexes
Internal or external resorption |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Count of colony forming units before treatment. |
Within 1hr of sample collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Count of colony forming units after treatment |
Within 1hr of sample collected |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
19/06/2024 |
| 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="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
purpose of this study is to comparatively evaluate antimicrobial efficacy of two herbal products neem and moringa extract used as irrigants with chlorhexidine in primary endodontic infections in single rooted teeth.Each tooth will be anesthetized and isolated with a rubber dam followed by caries removal. The access cavity will be prepared using a high-speed endo access bur. The working length (WL) will be determined radiographically using RVG by placing a size #10 K-file. The patients will be randomly divided into three groups: Group I: 2% chlorhexidine gluconate (CHX), Group II: Neem juice extract (Azadirachta indica), Group III: moringa juice extract (Moringa olifera).Pretreatment sample (S1) will be obtained by using a sterile paper point immersed in transport media first followed by placing it into the canal for 60secs and then transferred to the test tubes containing transport media (Peptone water). Two samples will be taken for each tooth. Biomechanical preparation (BMP) will be done using step-back technique up to master apical size #40 K-file. Irrigation will be done with 6 mL of the irrigants. Post-instrumentation sample (S2) will be similarly collected after irrigation as S1. It will be sent to the laboratory for processing within 2 hours. After this, teeth will be obturated using gutta-percha as a master cone and ZOE sealer. Microbiological samples (S1, S2,) will be sent to the lab Tropical Institute of Ecological Sciences(TIES)at Kottayam. Samples will be preincubated for 30 minutes and shaken vigorously in a vortex mixer for 60 seconds and will be plated on brain heart infusion agar and colonies will be counted after 24 hours using classic bacterial counting method. Both the session of treatment will be performed by the same examiner for each patient. The examiner will be aware of the material being used in every patient. A fidelity checklist will be developed using pertinent literature and after due consideration. An observer will fill the fidelity check list to ensure objectivity and transparency. |