CTRI Number |
CTRI/2023/05/052543 [Registered on: 11/05/2023] Trial Registered Prospectively |
Last Modified On: |
21/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Assessment of pain after single visit root canal treatment |
Scientific Title of Study
|
Comparative evaluation of postoperative pain after single visit endodontic treatment using Neolix neoniti and E3 Azure file system
-A randomized 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 |
Disha Dhananjay Raysad |
Designation |
Postgraduate student |
Affiliation |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
Address |
Department number 7, Department of Conservative Dentistry and Endodontics, second floor,
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010
Belgaum KARNATAKA 590010 India |
Phone |
9535428250 |
Fax |
|
Email |
dhananjaydishadr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Disha Dhananjay Raysad |
Designation |
Postgraduate student |
Affiliation |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
Address |
Department number 7, Department of Conservative Dentistry and Endodontics, second floor,
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010
KARNATAKA 590010 India |
Phone |
9535428250 |
Fax |
|
Email |
dhananjaydishadr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sonal B Joshi |
Designation |
Professor and Dean |
Affiliation |
KAHER KLE Vishwanath Katti Institute of Dental Sciences |
Address |
Department number 7, Department of Conservative Dentistry and Endodontics, second floor,
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010
Belgaum KARNATAKA 590010 India |
Phone |
9448141278 |
Fax |
|
Email |
jsonal70@yahoo.co.in |
|
Source of Monetary or Material Support
|
KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar,
Belagavi, 590010, Karnataka, India |
|
Primary Sponsor
|
Name |
Disha Dhananjay Raysad |
Address |
Department number 7, Department of Conservative Dentistry and Endodontics, second floor,
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar
Belgaum
KARNATAKA
590010 |
Type of Sponsor |
Other [[self funded]] |
|
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 |
Disha Dhananjay Raysad |
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar |
Department number 7, Department of Conservative Dentistry and Endodontics, second floor.
Belgaum KARNATAKA |
09535428250
dhananjaydishadr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Research and Ethics Committee KLE VKIDS |
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 |
E3 Azure |
Apical diameter of 0.25mm,6% Taper,Instrumentation according to manufacturers instruction |
Intervention |
Neolix Neoniti |
Apical diameter of 0.25mm,6% Taper,Instrumentation according to manufacturers instruction |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
INCLUSION CRITERIA
1.Patients requiring root canal treatment of maxillary premolar teeth with two root canals, diagnosed clinically as asymptomatic irreversible pulpitis using pulp sensitivity tests.
2.Patients ranging in the age group of 18-50 years.
3.Patients with non-contributory medical history.
4.Teeth with no pre-operative pain
5.Teeth with adequate coronal structure to ascertain proper isolation.
|
|
ExclusionCriteria |
Details |
EXCLUSION CRITERIA: -
PATIENT SPECIFIC:
1.Patients who refuse to consent for the procedure.
2.Patients with any systemic diseases, pregnancy or immuno - compromised conditions.
3.Patients on any antibiotic therapy in the past 3 months
4.Patients on any analgesic drugs in the past 7 days
5.Patients allergic to lignocaine in 1:80,000 concentration adrenaline
6.Patients allergic to Ibuprofen
7.Patients requiring root canal treatment of two or more teeth ipsilaterally (since the pain
caused by any of these teeth can result in false positive reading)
SPECIFIC TO DIAGNOSIS:
1.Teeth with acute apical periodontitis
2.Teeth with acute periapical abscess
3.Teeth with periapical radiolucency of diameter greater than0.5 cm (5 mm)
4.Teeth with an inflammatory exudate draining through the canal.
5.Necrotic painful teeth with absence of sinus tract for drainage
6.Re-treatment cases
7.Dilacerated teeth
8.Teeth with aggressive periodontitis or grade III mobility
TOOTH SPECIFIC:
1.Teeth with calcified canals, immature apex and internal and external resorption.
2.Two root canals ending with a single apical foramen.
3.Severe labially or lingually malpositioned teeth in which obtaining straight-line access is difficult.
4.If a #10 K-file is very resistant to movement or if a #20 K-file easily goes to length, then teeth with such canals will be excluded (apical gauging).
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate and compare the incidence and intensity of post-operative pain after single visit endodontic treatment using Neolix Neoniti and E3 Azure file system at 6, 24, 48 and 72 hours using Visual Analogue Scale |
6, 24, 48 and 72 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate and compare the association of variables (age and sex) between groups
|
6, 24, 48 and 72 hours |
|
Target Sample Size
|
Total Sample Size="68" Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/05/2023 |
Date of Study Completion (India) |
21/11/2023 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
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
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
· BACKGROUND OF STUDY: · Single visit endodontic treatment has gained preference over multiple visit endodontic due to advantages such as decreased number of operative procedures and no risk of inter-appointment leakage of the temporary restoration, and its economical. · There is an exponential growth in field of instrumentation to treat complexity of canal, great amount of research is been undertaken regarding the materials of file system and their manufacturing procedures. · Neolix neoniti and E3 Azure file system both are extremely flexible and resistant to breakage. However, they are made from different technology and have different cross sections. Both of these instruments are responsible in very big way for causing extrusion of debris which is normally seen phenomenon with any instrument used with any technique · So, this kind of extrusion of debris which is one of the main causative factors for post operative pain that instrument which cause minimal extrusion becomes prudent as it causes less pain · Invitro study done on Neolix neoniti claimed to have decreased apical debris extrusion Whereas in vivo study done on E3 Azure with and without maintaining apical patency did not show significant post operative pain thus it leads to aim of study · PURPOSE: · To evaluate and compare incidence and intensity of the post - operative pain after single visit endodontic treatment using Neolix neoniti and E3 Azure file systems. · To evaluate and compare the time required for instrumentation of canals in both groups. · To evaluate and compare the association of variables (age and sex) between groups. |