| CTRI Number |
CTRI/2025/01/079081 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Pain killer injection solutions used during root canal treatment on pain after treatment. |
|
Scientific Title of Study
|
Effect of Four Different Irrigants as a Final Rinse on Post Operative Pain Following Single Sitting Root Canal Treatment in Symptomatic Irreversible Pulpitis: A Randomised Control 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 Aarya Rajan Mankodi |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
117, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Medical Square, Nagpur, Maharashtra
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9821481902 |
| Fax |
|
| Email |
aaryamankodi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Raina |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
117, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Medical Square, Nagpur, Maharashtra
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9423685967 |
| Fax |
|
| Email |
drsadhanaraina@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Raina |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
117, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Medical Square, Nagpur, Maharashtra
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9423685967 |
| Fax |
|
| Email |
drsadhanaraina@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Nagpur
Government Dental College and Hospital Nagpur, Medical Square, Nagpur, Maharashtra-440003
|
|
|
Primary Sponsor
|
| Name |
Dr. Aarya Rajan Mankodi |
| Address |
117, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Medical Square, Nagpur-440003 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 Aarya Rajan Mankodi |
Government Dental College and Hospital , Nagp |
117, Department
of Conservative
Dentistry and
Endodontics,
Government Dental
College and Hospital
Nagpur
Nagpur
MAHARASHTRA |
9821481902
aaryamankodi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College and Hospital, Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Patients receiving Dexamethasone solution as irrigant and final rinse prior to obturation during the single visit Root canal Treatment. Duration of the interventions will be only during the time of single visit root canal therapy as they will be used as irrigating solutions. |
| Intervention |
Diclofenac Sodium |
Patients receiving Diclofenac Sodium solution as irrigant and final rinse prior to obturation during the single visit Root canal Treatment. Duration of the interventions will be only during the time of single visit root canal therapy as they will be used as irrigating solutions. Duration of the interventions will be only during the time of single visit root canal therapy as they will be used as irrigating solutions. |
| Intervention |
Ketorolac Tromethamine |
Patients receiving Ketorolac Tromethamine as irrigant and final rinse prior to obturation during the single visit Root canal Treatment |
| Comparator Agent |
Normal Saline |
Patients receiving Normal Saline as irrigant and final rinse prior to obturation during the single visit Root canal Treatment. Duration of the interventions will be only during the time of single visit root canal therapy as they will be used as irrigating solutions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy patients aged between 18-60 years.
2.Permanent mandibular single rooted teeth with complete root formation.
3.Permanent mandibular single rooted teeth with diagnosis of symptomatic irreversible pulpitis
|
|
| ExclusionCriteria |
| Details |
1.Patients who are medically compromised.
2.Patients who had taken antibiotics in last 1 month and non-steroidal anti-inflammatory drugs 24 hours prior to procedure.
3.Patients contraindicated for Diclofenac Sodium, Ketorolac Tromethamine, Lignocaine, use of apex locator
4.Patients allergic to latex
5.Patients who are denied consumption of steroids due various reasons.
6.Patients who have renal and hepatic disorder
7.Patients with loss of tooth structure such that a rubber dam cannot be applied.
8.Pregnant and lactating women.
9.Adjacent carious teeth which are suspected of pulpal involvement.
10.Immature teeth or teeth with root resorption.
11.Teeth with calcified canals.
12.Teeth with sinus opening or periapical radiolucency with PAI score of 3 or higher.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain |
6 hours, 24 hours, 48 hours, 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative Analgesic Consumption |
6 hours, 24 hours, 48 hours, 72 hours |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Postoperative
pain is a usual and unpredictable outcome of endodontic treatment. Different
studies show that prevalence of Post Operative pain is 3% to 58%. It is the
yardstick of clinician’s skill according to the patients. Symptomatic
Irreversible pulpitis is a pulpal pathosis that requires Root Canal treatment.
Just like any other inflamed tissue, inflamed pulp cells showed the presence of
COX-2 positive cells. Steroidal anti-inflammatory
agents function by inhibiting phospholipase-A2, while non-steroidal
anti-inflammatory drugs operate by blocking cyclooxygenase enzymes, resulting
in a decrease in levels of prostaglandins and leukotrienes. Dexamethasone is a potent
steroid with great anti-inflammatory action. Diclofenac Sodium is a
preferential COX-2 inhibitor. Ketorolac tromethamine, a
potent NSAID, is over 400 times
more potent as a selective inhibitor of COX-1 and COX-2 than many other drugs Well
done and copious irrigation is a must for a successful endodontic treatment. In recent times , there has been a peaked interest to scope
out newer irrigants that are multi faceted i.e. disinfection as well as provide
symptomatic relief. There are many
studies to compare newer irrigants and effects on post operative pain. The irrigants selected in this study have
proven to provide symptomatic relief on oral consumption i.e. systemic
administration. It is also known that
local deposition of drug has increased bioavailability than systemic
administration .There are no studies which compare Diclofenac Sodium,
Dexamethasone, Ketorolac Tromethamine to be used as an irrigants and a final
rinse check its effect on Post Operative Pain. |