| CTRI Number |
CTRI/2019/12/022402 [Registered on: 17/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Of The Incidence Of Postoperative Pain Using Different Single File Systems: A Prospective, Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparison Of The Incidence Of Postoperative Pain After Using Different Single File Systems: A Prospective, Randomized Clinical Trial |
| Trial Acronym |
PPSFS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kriti Kapoor |
| Designation |
Postgraduate student |
| Affiliation |
SGT Dental College Hospital And Research Institute, Budhera Gurugram |
| Address |
SGT Dental College Hospital And Research Institute Village Budhera District Gurugram 122505
SGT Dental College Hospital And Research Institute Village Budhera District Gurugram 122505
Gurgaon
HARYANA
122505
India |
| Phone |
08076872106 |
| 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 Gurugram |
| Address |
SGT Dental College Hospital And Research Institute Village Budhera District Gurugram 122505
SGT Dental College Hospital And Research Institute Village Budhera District Gurugram 122505
Gurgaon
HARYANA
122505
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 Gurugram |
| Address |
SGT Dental College Hospital And Research Institute Village Budhera District Gurugram 122505
SGT Dental College Hospital And Research Institute Village Budhera District Gurugram 122505
Gurgaon
HARYANA
122505
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 |
SGT Dental College Hospital And Research Institute, Budhera Gurugram |
| Type of Sponsor |
Other [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
Gurgaon
HARYANA |
08076872106
kriti2060@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Ritu Duggal chairperson Dr Mandeep S Grewal member secretary Dr Poonam Salwan Mr Dinesh Mr Azad Singh Dr Anil Gupta Mr Sachinder Chauhan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
this is a randomized clinical trial done on healthy human volunteers with irreversible pulpitis in mandibular molar teeth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Mandibular molars of patients aged between 18
to 40 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 |
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.
17.Teeth with wide canals |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain after root canal treatment using different single file systems . |
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)
|
17/12/2019 |
| Date of Study Completion (India) |
20/03/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/03/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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 Using Different Single File Systems: 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 is a Prospective Randomized Clinical trial to evaluate postoperative pain after root canal treatment using three different single file systems.Other criterias assessed were treatment time and systemic analgesic intake at 24 hrs, 48 hrs, 72 hrs and 7 days. Single visit root canal treatment is done to assess pain level after root canal treatment, also analgesic intake and total treatment time. All subjects will be asked to mark pain on Heft Parkers Visual Analog Scale to analyse the level of pain. Data will be subjected to statistical analysis. |