| CTRI Number |
CTRI/2024/01/061415 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Post Root Canal Treatment Pain after using Two Different File Systems proTaper Ultimate and WaveOne Gold. |
|
Scientific Title of Study
|
Comparative Evaluation of PostOperative Pain using proTaper Ultimate and WaveOne Gold in Single Visit Endodontics: 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 |
Dr Aarti Arora |
| Designation |
Post Graduate Resident |
| Affiliation |
JCD DENTAL COLLEGE SIRSA |
| Address |
Room no. 7 , Department of Conservative and Endodontics ,JCD Vidhyapeeth Sirsa
Haryana
Sirsa
HARYANA
125055
India |
| Phone |
9050608983 |
| Fax |
|
| Email |
aartiarora0202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Singla |
| Designation |
Head Of Department |
| Affiliation |
JCD Vidhyapeeth Sirsa |
| Address |
Room no. 7 , Department of Conservative and Endodontics ,JCD Vidhyapeeth Sirsa
Haryana
Sirsa
HARYANA
125055
India |
| Phone |
9466671007 |
| Fax |
|
| Email |
singlaendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarti Arora |
| Designation |
Post Graduate Resident |
| Affiliation |
JCD Vidhyapeeth Sirsa |
| Address |
Room no. 7 , Department of Conservative and Endodontics ,JCD Vidhyapeeth Sirsa
Haryana
Sirsa
HARYANA
125055
India |
| Phone |
09050608983 |
| Fax |
|
| Email |
aartiarora0202@gmail.com |
|
|
Source of Monetary or Material Support
|
| JCD Dental College , Sirsa , Haryana |
|
|
Primary Sponsor
|
| Name |
JCD Dental College |
| Address |
JCD Vidhyapeeth , Barnala road, Sirsa , Haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aarti Arora |
JCD dental college |
Room no. 7, Department of conservative and endodontics, JCD Dental College, barnala road, Sirsa
Sirsa
HARYANA |
09050608983
aartiarora0202@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
advised for intentional root canal treatment for prosthetic purpose |
| Patients |
(1) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Root canal treatment with proTaper Ultimate file system |
single visit root canal treatment using rotation motion with proTaper Ultimate file system. |
| Comparator Agent |
Root Canal Treatment with WaveOne Gold file System |
single visit root canal treatment using reciprocating motion with WaveOne Gold file system. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving informed consent for the study
Healthy patients(ASA I or II) with age ranging from 18-60 years
Patients with vital asymptomatic teeth indicated for elective endodontic treatment for prosthetic purpose. |
|
| ExclusionCriteria |
| Details |
Patient whose age is less than 18 year and more than 60 years.
patients allergic to LA or any other component of LA solution.
Patient having history of medicine intake including corticosteroids, opioids or NSAIDS in past 12 hours.
Complicated anatomy, internal and external resorption, open apices,
Non vital teeth,
symptomatic teeth, endodontically treated teeth/initiated teeth, periapical lesion(periapical index>2), pregnant patients , drug abusers and alcoholics |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Evaluate Incidence of Post Operative Pain experienced by the patients after using WaveOne Gold and proTaper Ultimate in single visit Endodontics
|
6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs , 7th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the number of analgesics intake after Endodontics treatment |
6 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs , 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/01/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pain after endodontic treatment remains a major problem. The common factor influencing the occurrence of pain after root canal treatment include presence of preoperative pain, insufficient instrumentation, irrigant extrusion, hyperocclusion , missed canals, presence of periapical pathosis, apical debris extrusion, and apical patency during root canal preparation. Periradicular inflammation associated with apical extrusion of debris remains the leading cause of post operative pain. The amount of debris extrusion varies according to the instrument system used, but so far no system has been able to prevent its occurence. NiTi instruments or the engine driven instruments are broadly classified into two category rotary and reciprocating on the basis of their mode of action.The Purpose of this study is to evaluate the post operative pain using ProTaper Ultimate (rotation system) and WaveOne Gold (reciprocating system) in single visit endodontic treatment. |