| CTRI Number |
CTRI/2018/02/011652 [Registered on: 01/02/2018] Trial Registered Prospectively |
| Last Modified On: |
12/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Of The Incidence Of Postoperative Pain After Using different Rotary System:A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparison Of The Incidence Of Postoperative Pain After Using Single File,Two File And Multiple File Rotary System:A Randomized Clinical Trial |
| Trial Acronym |
POPUDRS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kriti Kapoor |
| Designation |
MDS student |
| Affiliation |
SGT Dental College Hospital And Research Institute, Budhera Gurgaon |
| Address |
House NO 799, Block C,Vikaspuri, New Delhi 110018
SGT Dental College, Hospital And Research Institute,Village Budhera, District Gurgaon,122505
New Delhi
DELHI
110018
India |
| Phone |
8076872106 |
| Fax |
|
| Email |
kriti2060@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
Professor and Head of Deptt Conservative dentistrty |
| Affiliation |
SGT Dental College Hospital And Research Institute, Budhera Gurgaon |
| Address |
5804, Ground Floor, Aster Avenue, Near Supermart I Market, DLF Phase IV, Gurgaon 122009
SGT Dental College, Hospital And Research Institute,Village Budhera, District Gurgaon,122505
Gurgaon
HARYANA
122009
India |
| Phone |
9810805880 |
| Fax |
01128711111 |
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep S Grewal |
| Designation |
Professor and Head of Deptt Conservative dentistrty |
| Affiliation |
SGT Dental College Hospital And Research Institute, Budhera Gurgaon |
| Address |
5804, Ground Floor, Aster Avenue, Near Supermart I Market, DLF Phase IV, Gurgaon 122009
SGT Dental College, Hospital And Research Institute,Village Budhera, District Gurgaon,122505
Gurgaon
HARYANA
122009
India |
| Phone |
9810805880 |
| Fax |
01128711111 |
| Email |
drmandeepsgrewal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr Kriti Kapoor (self sponsored) |
|
|
Primary Sponsor
|
| Name |
Dr Kriti Kapoor |
| Address |
House No 799 Block C Vikaspuri New Delhi 110018 |
| Type of Sponsor |
Other [Mds Student thesis self sponsered] |
|
|
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 Kriti Kapoor |
SGT Dental College, Hospital & Research Institute |
SGT Dental College Building, Second floor,Room No 5,
Near Sultanpur Bird Sanctuary
Village Budhera, District Gurgaon,Haryana
Pin: 122 505
Gurgaon
HARYANA |
8076872106
kriti2060@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Prof Dr Sangeeta Talwar as chairperson, Dr Anil Gupta member secretary,Dr Poonam Salwan,Mr Dinesh,Prof N S Bawa,Dr G N Suma,Mr Sachinder Chauhan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Irreversible Pulpitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not applicable |
not applicable |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1.Mandibular molars of patients aged between 20
to 45 years with no systemic disease.
2.No history of trauma to the involved tooth.
3.No periapical radiolucency related to the
involved tooth.
4.No parafunctional habit.
5.No pus or inflammatory exudate draining
through the canal or sinus tract.
6.No tenderness on percussion in the
involved tooth.
7.Positive response on cold testing and
electric pulp testing.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1.Patients with non-vital teeth.
2.Presence of sinus tracts or draining pus.
3.Cases of apical periodontitis.
4.Radiographic evidence of a periapical lesion.
5.Endodontic Retreatment cases.
6.Root resorption cases.
7.Immature or open apex cases
8.Root canal in which patency of apical foramen
could not be established.
9.Patients whose teeth had issues precluding
single visit treatment.
10.Teeth with anatomic variations and difficult
root anatomy (canal curvatures >25 degree
radiographic evidence of calcification.
11.Patients using some type of medication
preoperatively such as analgesics or
steroidal anti-inflammatory drugs.
12.Patients with any uncontrolled systemic
diseases.
13.Patients with allergies to sodium
hypochlorite.
14.Medically compromised patients.
15.Missing antagonist tooth.
16.Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain after root canal treatment using single file, two file and multiple file rotary system . |
Pain assessment of the patient after 24 hrs,48 hrs, 72 hrs and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for the treatment in every patient;
Systemic analgesic intake of patient if any
|
Systemic analgesic intake of patient after 24 hrs, 48 hrs,72 hrs and 7 days. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
28/09/2018 |
| Date of First Enrollment (Global) |
01/02/2018 |
| Date of Study Completion (Global) |
28/09/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Comparison of the Incidence Of Postoperative Pain After Using Single File, Two File and Multiple File Rotary System: A Prospective Randomized Clinical Trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Randomised Clinical Trial to evaluate and compare postoperative pain using single file, two file and multiple file rotary systems.This study also compares the time taken to prepare the canal using single file, two file and multiple file rotary system.It also compares the quantity of analgesics taken by the patient after treatment till 7 days using these three different rotary file systems.The trial will be conducted on patients falling in the inclusion criteria at SGT Dental College, Hospital and Research Institute, Gurgaon, Haryana in India. Post operative pain will be rated by the patient after 24 hrs, 48 hrs, 72 hrs and after 7 days on Heft Parker Scale.The study includes mandibular molars of patients aged between 20 to 45 years with irreversible pulpitis having no systemic disease. Also teeth with periapical lesion, endodontic retreatment cases, sinus tracts, apical periodontitis, root resorption, open apex cases will be excluded from the study. The primary outcome of the study is comparison of postoperative pain and secondary outcomes are analgesic intake by the patient, if any and comparing treatment time using three different rotary systems. |