| CTRI Number |
CTRI/2021/06/034295 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of postoperative pain intensity after using different systems in symptomatic patients |
|
Scientific Title of Study
|
Comparative Evaluation Of Postoperative Pain Intensity In Symptomatic Irreversible Pulpitis
After Using Different
Mechanical Glide Path Systems :
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 |
Tarshit Malik |
| Designation |
Post Graduate Student |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
Room No. 5, Department of Conservative Dentistry & Endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9728580999 |
| Fax |
|
| Email |
drmalik25tarshit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
Professor & Head of Department |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
Room No. 5, Department of Conservative Dentistry & Endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9810805880 |
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
Professor & Head of Department |
| Affiliation |
SGT University, Gurugram, Haryana |
| Address |
Room No. 5, Department of Conservative Dentistry & Endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9810805880 |
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| SGT University, Gurugram, Haryana. |
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
Room No. 5, Department of Conservative Dentistry & Endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana, 122505 |
| 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 |
| Tarshit Malik |
SGT University |
Room no. 5, Department of Conservative Dentistry & Endodontics
Faculty of Dental Sciences, SGT University, Gurugram, Haryana,
India. 122505
Gurgaon
HARYANA |
9728580999
drmalik25tarshit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGT University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R52||Pain, unspecified, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manual Glide Path Preparation |
Glide Path will be prepared with manual instruments in first group (control)and compared with reciprocating instruments in second and third group and with rotary instruments in fourth and fifth group. |
| Intervention |
Reciprocating vs Rotary Glide Path Preparation |
Glide path will be prepared with reciprocating instruments in second and third group and with rotary instruments in fourth and fifth group. Postoperative pain will be evaluated for these groups |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with symptomatic irreversible pulpitis in systemically healthy patients
Positive response to vitality tests and a history of pain and presenting symptoms characteristic of symptomatic irreversible pulpitis
Patients with Moderate to Severe pain according to HP VAS Scale
|
|
| ExclusionCriteria |
| Details |
Patients with a diagnosis of asymptomatic irreversible pulpitis
Patients having pulp necrosis, sinus tract, periapical abscess, or facial cellulitis
Patients having a negative response to pulp vitality tests
Teeth with inadequate tooth structure or poor periodontal status |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
6hrs,12hrs,24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
48hrs, 72hrs & 1 week |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
Final Enrollment numbers achieved (Total)= "175"
Final Enrollment numbers achieved (India)="175" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/06/2021 |
| Date of Study Completion (India) |
30/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Will be Published once the study is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
175 Patients presenting with symptomatic irreversible pulpitis will be selected on the basis of inclusion & exclusion criteria for the study.Randomisation will be done using coloured tokens and patients will be divided into 5 groups namely : manual glide path group, R – Motion Glider Group (reciprocating), Wave One Gold Glider Group (reciprocating), TruNatomy
Glider Group (rotary) & Hyflex EDM Glider Group (rotary).
Treatment plan will be explained to the subjects and an informed consent will be taken.
Local anaesthesia will be given, proper rubber dam isolation will be done prior to commencement of procedure.
In the manual glide path group, glide path will be created using stainless steel k files and working length will be recorded.
In all the mechanical glide path groups, stainless steel k files will be used to measure Working Length. The files will be used according to manufacturer’s instructions till defined working length.
After glide path creation, subsequent endodontic procedures including chemomechanical preparation and obturation will be standardized for all five groups
Complete Root Canal Procedure would be completed in the same sitting. TruNatomy File System (Dentsply) will be used to prepare the root canals
During instrumentation, irrigation will be done thoroughly in all the groups. A standard irrigation protocol will be followed for all the groups. Irrigation will be performed with a TruNatomy 30-gauge double side vent needle. Master cone will be checked by taking radiograph , after that obturation will be done in the same sitting followed by restoration, Complete treatment will be done by a single operator in a single sitting. Patients will be given post operative instructions, a prescription for optional analgesics & a HP VAS scale form which needs to be filled by patient at : 6hrs,12hrs,24hrs,48hrs,72hrs & 1 week post treatment. Patients will also be instructed to keep a record of analgesic intake. |