| CTRI Number |
CTRI/2024/10/075689 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of different irrigation methods in reducing bacterial load and pain after root canal treatment. |
|
Scientific Title of Study
|
Comparison of activated versus non activated irrigation for reductions in bacterial load and postoperative pain: A randomized controlled trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| venkat964 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vookanti Venkat ramana reddy |
| Designation |
Post Graduate student |
| Affiliation |
Mahatma Gandhi Dental college and hospital jaipur |
| Address |
Department of conservative dentistry and endododntics,room number 5 fisrt floor,mahatma gandhi dental college and hospital,Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 303905
Jaipur
RAJASTHAN
303905
India |
| Phone |
8074036514 |
| Fax |
|
| Email |
venkatramanareddy964@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr .prachi mittal |
| Designation |
reader |
| Affiliation |
Mahatma Gandhi Dental college and hospital jaipur |
| Address |
Department of conservative dentistry and endododntics,room number 5 fisrt floor,mahatma gandhi dental college and hospital,Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 303905.
Jaipur
RAJASTHAN
303905
India |
| Phone |
9829084781 |
| Fax |
|
| Email |
drprachimittal@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vookanti Venkat ramana reddy |
| Designation |
Post Graduate student |
| Affiliation |
Mahatma Gandhi Dental college and hospital jaipur |
| Address |
Department of conservative dentistry and endododntics,room number 5 fisrt floor,mahatma gandhi dental college and hospital,Ricco Industrial Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 303905.
Jaipur
RAJASTHAN
303905
India |
| Phone |
8074036514 |
| Fax |
|
| Email |
venkatramanareddy964@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of conservative dentistry and endododntics,room number 5 fisrt floor,mahatma gandhi dental college and hospital,RIICO Institutional Area
Sitapura, Tonk Road, Jaipur, Rajasthan (India) – 302022 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Dental College and Hospital jaipur |
| Address |
Department of conservative dentistry and endododntics,room number 5 fisrt floor,mahatma gandhi dental college and hospital,RIICO Institutional Area
Sitapura, Tonk Road, Jaipur, Rajasthan (India) – 302022 |
| Type of Sponsor |
Other [Mahatma Gandhi Dental College and Hospital jaipur] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vookanti Venkat ramana reddy |
Mahatma Gandhi Dental College and Hospital jaipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vookanti Venkat ramana reddy |
Mahtma Gandhi Dental college and hospital jaipur |
Department Of Conservative and endodontics Room no 5 Sitapura,Jaipur,302022
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8074036514
venkatramanareddy964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGDC jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sidevented needle irrigation |
I will use a side-vented needle for irrigation and will be done with 6 ml of 2.5% NaOCl and a 31G, 27 mm NaviTip, Side port needle, 1 mm from the working length for 3 min (flow rate, 2 ml/min). this will be followed by irrigation with 1 ml of 17% EDTA for 1 min and 1 ml of 2% chlorhexidine for 1 min. |
| Intervention |
Ultrasonic versus air sonic irrigation. |
I will assess the reduction in bacterial load by collecting samples from inside the root canal using paper points and performing bacterial cultures. Additionally, I will evaluate post-operative pain using a visual analog scale at 6, 12, 24, and 48 hours after the root canal procedure. The study will compare different irrigation methods, including AirSonic irrigation (30 seconds per irrigant), and ultrasonic irrigation (30 seconds per irrigant), using three chemical irrigants: sodium hypochlorite, chlorhexidine, and ethylenediaminetetraacetic acid (EDTA). |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age range 18-55 years.
2.Single rooted teeth with or without apical periodontitis.
3.Teeth with adequate crown structure for isolation.
|
|
| ExclusionCriteria |
| Details |
1.Periapical radiolucency and severe periodontal diseases.
2.Patients undergoing orthodontic treatment.
3.Pregnant and lactating patients.
4.Teeth with complex root canal morphology or calcified canals.
5.Patients with chronic systemic disease. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the reduction in bacterial load through the use of three different irrigation methods on three separate groups. |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the reduction in post operative pain through the use of three different irrigation methods on three separate groups |
1year |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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="6"
Days="0" |
|
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
|
As the field of
endodontics evolves, there is a continual need to explore and incorporate
advanced techniques to enhance treatment outcomes.
Researching and
studying the use of advanced irrigation techniques contribute to the
advancement and refinement of endodontic practice.
Traditional irrigation
methods, such as syringe irrigation, may struggle to reach the entirety of the
root canal system, especially areas with complex anatomy like isthmuses, fins,
and accessory canals. This limitation can result in inadequate disinfection and
debris removal and increasing the risk of infection and treatment failure.(1,2)
Syringe irrigation, can
lead to procedural accidents such as extrusion of irrigants beyond the apex,
causing irritation to periapical tissues or even inducing post-operative pain
and swelling.(1,2)
Manual irrigation
techniques lack the precision and control offered by advanced irrigation
systems.(1)
Traditional irrigation
methods may prolong the duration of endodontic treatment due to the need for
repetitive irrigation and aspiration cycles.
These
limitations highlight the need for the development and adoption of advanced irrigation techniques in modern
endodontic practice.
Effective
irrigation is essential for the successful elimination of microorganisms and
debris from the root canal system which is achieved by use of newer advanced
irrigation methods like sonic and ultrasonic irrigation which increases the
efficacy of root canal treatment.(1)
They can
potentially reduce the time required for root canal treatment by improving the
efficiency of debris and bacteria removal.(1)
Advanced
techniques gives better results in case of challenging endodontic cases like
complex root canal anatomy, such as curved or narrow canals, isthmuses, and
apical deltas.(1)
These
techniques helps in enhanced tissue preservation by
minimizing the need for aggressive mechanical instrumentation.(1)
Improved
treatment outcomes resulting from advanced irrigation techniques can lead to
higher patient satisfaction and safety and improved long-term prognosis for
treated teeth.
The use of
optimal combination of irrigation solutions and techniques is crucial for
achieving the best treatment outcomes.
|