| CTRI Number |
CTRI/2023/09/057368 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [dentistry ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the incidence of postoperative pain after single visit endodontic treatment using trunatomy and hyflex cm rotary file systems in posterior teeth: A randomized clinical trial |
|
Scientific Title of Study
|
Comparative evaluation of postoperative pain in teeth with irreversible pulpitis after single visit endodontic treatment using trunatomy and hyflex cm rotary file systems in posterior teeth: A Randomized Clinical Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prathipati Supriya |
| Designation |
Post graduate |
| Affiliation |
DRS Sudha and nageswararao siddhartha institute of dental sciences |
| Address |
Drs Sudha and Nageswararao siddhartha Institute of dental
sciences
Department of conservative dentistry and endodontics
chinaoutpalli gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
7780662392 |
| Fax |
|
| Email |
prathipatisupriya968@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Rambabu |
| Designation |
Professor and Hod |
| Affiliation |
Drs Sudha and nageswararao siddhartha institute of dental sciences |
| Address |
DRS Sudha and Nageswararao siddhartha institute of dental
sciences Department of conservative dentistry and endodontics
chinaoutpalli gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
rambabumds@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Rambabu |
| Designation |
Professor and Hod |
| Affiliation |
DRS Sudha and Nageswararao siddhartha institute of dental sciences |
| Address |
Drs Sudha and Nageswararao siddhartha institute of dental
sciences
Department of conservative dentistry and endodontics
chinaoutpalli gannavaram mandal
Krishna
ANDHRA PRADESH
521286
India |
| Phone |
9440364064 |
| Fax |
|
| Email |
rambabumds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs Sudha and Nageswarrao d-siddartha institute of dental sciences
Department of conservative dentistry and endodontics chinnaoutpalli |
|
|
Primary Sponsor
|
| Name |
Prathipati Supriya |
| Address |
Drs sudha and nageswara rao siddhartha institute of dental
sciences |
| 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 |
| Prathipati Supriya |
Drs sudha and nageswararao siddhartha institute of dental sciences gannavaram |
Room no 7
conservative dentistry and endodontics department
Krishna
ANDHRA PRADESH |
7780662392
prathipatisupriya968@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DRS SUDHA AND NAGESWARA RAO SIDDHARTHA INSTITUTE OF DENTAL SCIENCES INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IBUPROFEN |
patients will be instructed to take mild analgesic ( 400mg ibuprofen ) and it will be recorded at that particular time interval . The patients will be instructed to
call the clinic if adequate pain relief is not obtained
with the prescription. |
| Comparator Agent |
Rotary file systems |
Hyflex cm and trunatomy files will be used for biomechanical preparation after working length determination |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Teeth with irreversible pulpitis |
|
| ExclusionCriteria |
| Details |
IMMUNOCOMPROMIZED
PREGNANT WOMEN
H/O ANALGESICS AND ANTIBIOTICS PAST 24HRS
BRUXISM
ACUTE PERIAPICAL ABSCESS AND SWELLING
TEETH WITH GREATER THAN GRADE 1 MOBILITY AND 5MM PERIODONTAL POCKET
NON RESTORABILITY
EVIDENCE OF INTERNAL/EXTERNAL RESORPTION
CALCIFICATIONS
IMMATURE TEETH |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain |
At 6,24,48.72 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANALGESIC CONSUMPTION |
AT 6,24,48,72 HRS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/09/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
In this study ,comparing the incidence of postoperative pain after single visit endodontic treatment with two different rotary file systems hyflex cm and trunatomy at 6,24,48,72hrs time interval using modified visual analogue scale number of patients taking in this study are 40 |