| CTRI Number |
CTRI/2025/02/080702 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Pain After Single Visit Root Canal: A Comparative Study on Different Instrumentation Systems |
|
Scientific Title of Study
|
Post-Operative Pain Assessment Following Single Visit Root Canal Treatment Performed by Different Instrumentation Systems: A Randomized Clinical 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 |
Abhiroop Kaur |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Conservative Dentistry and Endodontics |
| Address |
Department of Conservative Dentistry and Endodontics, Room Number 7, Bhojia Dental College and Hospital, Baddi
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9878474861 |
| Fax |
|
| Email |
abhiroopkaur123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Himani Lau |
| Designation |
Professor and Head of Department |
| Affiliation |
Department of Conservative Dentistry and Endodontics, Bhojia Dental College and Hospital |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 7, Bhojia Dental College and Hospital, Baddi.
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
7982908801 |
| Fax |
|
| Email |
drhimanilau@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhiroop Kaur |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Conservative Dentistry and Endodontics |
| Address |
Department of Conservative Dentistry and Endodontics, Room number 7, Bhojia Dental College and Hospital, Baddi
Solan
HIMACHAL PRADESH
173205
India |
| Phone |
9878474861 |
| Fax |
|
| Email |
abhiroopkaur123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics, Bhojia Dental College and Hospital, Baddi |
|
|
Primary Sponsor
|
| Name |
Abhiroop Kaur |
| Address |
Department of Conservative Dentistry and Endodontics, Bhojia Dental College and Hospital, Baddi |
| 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 |
| Abhiroop Kaur |
Bhojia Dental College and Hospital |
Department of Conservative Dentistry and Endodontics, Room Number 7
Solan
HIMACHAL PRADESH |
9878474861
abhiroopkaur123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Bhojia Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers with Symptomatic Irreversible Pulpitis affecting Mandibular Premolars who require a Root Canal Treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hand K file |
Root canal instrumentation will be carried out by using stainless steel hand K-file. The instrumentation will be done only once in a single visit.
Hand filing will be carried out where the canals will be instrumented with stainless steel K-files using the step back technique with watch-winding motion. |
| Intervention |
Reciproc Blue file |
Root canal instrumentation will be carried out by using Reciproc Blue file in reciprocating motion. Instrumentation will be done only once in a single visit.
Instrumentation with Reciproc Blue file, R25 (25/0.08) will be carried out as per manufacturers instructions. Three small, in and out movements (pecks) with amplitude of 2-5mm will be carried out in the cervical, middle, and apical thirds until attaining the established working length. The file will be withdrawn after three pecks, flutes cleaned and canal irrigated. |
| Intervention |
TruNatomy file |
Root canal instrumentation will be carried out by using truNatomy file system used in continuous rotary motion. Instrumentation will be done only once in a single visit.
Endomotor will be adjusted at 500rpm/1.5Ncm and instrumentation will be carried out as per manufacturers instructions. A TRN Orifice Modifier (20/0.08) will be used in the coronal third only, followed by a TRN glider (17/0.02) and the prime instrument (26/0.04). each instrument will be gently advanced into the root canal 2-3 times, each no more than 2-5 mm. The file will be then withdrawn and flutes
will be cleaned followed by irrigation of canal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted mandibular premolar.
Patient with symptomatic irreversible pulpitis.
Periodontally sound teeth. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients and pregnant women.
Patients with history of medicine intake including NSAIDs, antibiotics, corticosteroids, opioids, sedatives, anti-anxiety or anti-depressants in past week.
Teeth with evidence of internal or external root resorption, root fracture, calcification, open apices and periapical lesion.
Teeth with more than one canal.
Patients with physical or psychological disabilities or inability to understand study instructions.
Patients who refuse to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the post-operative pain of patients undergoing single visit root canal treatment after instrumentation with Hand K-file, TruNatomy file and Reciproc Blue file |
5 time points: 6,12, 24, 48 and 72 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the need for post-operative analgesic medication following single visit root canal treatment after instrumentation with Hand K-file, TruNatomy file and Reciproc Blue file.
|
5 time points: 6,12, 24, 48 and 72 hours.
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/03/2025 |
| 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 Applicable |
| 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
|
This study aims to assess the post operative pain following single visit root canal treatment performed by three instrumentation systems that is hand filing with stainless steel hand K file, TruNatomy rotary system and Reciproc Blue reciprocating system. The pain will be assessed following treatment at 6, 12, 24,48 and 72 hours using 4 point verbal rating scale. All diagnosis and treatment will be performed by a single operator to eliminate or minimize individual variability in the treatment between the clinical. This research could potentially lead to knowledge of more efficient instrumentation system and improved root canal treatment protocols. resulting in painless outcomes for the patient. |