| CTRI Number |
CTRI/2025/08/092563 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A randomized control trial comparing postoperative pain in patients with symptomatic irreversible pulpitis receiving a singlevisit root canal after premedication with three different antiinflammatory drugs |
|
Scientific Title of Study
|
Comparison of Postoperative pain after Premedication with three different Anti-inflammatory Drugs in Single-visit root canal treatment for patients diagnosed with Symptomatic Irreversible Pulpitis - A Randomized 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 Abhay Wasu |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College And Research Center Nagpur |
| Address |
Department of Conservative Dentistry and Endodontics Ranjeet Deshmukh Dental College And Research Center Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7350215236 |
| Fax |
|
| Email |
abhaywasu111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautam Badole |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College And Research Center Nagpur |
| Address |
Department of Conservative Dentistry and Endodontics Ranjeet Deshmukh Dental College And Research Center Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9665410655 |
| Fax |
|
| Email |
badole_g15@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Wasu |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College And Research Center Nagpur |
| Address |
Department of Conservative Dentistry and Endodontics Ranjeet Deshmukh Dental College And Research Center Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7350215236 |
| Fax |
|
| Email |
abhaywasu111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study will be conducted at department of conservative dentistry and endodontics at Ranjeet Deshmukh Dental College and Research Center Nagpur 440019 |
|
|
Primary Sponsor
|
| Name |
Department of conservative dentistry and endodontics |
| Address |
Ranjeet Deshmukh Dental college And hospital nagpur 440019 |
| 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 |
| Dr Abhay Wasu |
Ranjeet Deshmukh Dental College And Research Center Nagpur 440019 |
Department of Conservative Dentistry and Endodontics 311 floor 3rd
Nagpur
MAHARASHTRA |
7350215236
abhaywasu111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 120 mg oral Etoricoxib
Group 2 20 mg oral Piroxicam
Group 3 10 mg oral Ketorolac
|
Each of the study group drug will be give by oral route 30 minute before the root canal treatment and pain will be evaluated upto 72 hours by call and messages |
| Comparator Agent |
Group 2 20 mg oral Piroxicam Group 3 10 mg oral Ketorolac |
All the groups will be compared with each other and Each of the study group drug will be give by oral route 30 minute before the root canal treatment and pain will be evaluated upto 72 hours by call and messages |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged 18 to 60 will be included in the study.
2. Both male and female.
3. Systemically healthy patients (Category: American Society of Anesthesiologists class 1).
4. Single rooted tooth diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis.
5. Teeth will be included if they have moderate sharp spontaneous pain preoperative visual analogue scale .
6. Ability to read and comprehend the visual analogue scale sheets and informed consent
7. Teeth that demonstrated tenderness upon percussion, along with a positive reaction to electric pulp testing and a prolonged response exceeding 10 seconds to cold testing.
8. The teeth with periapical changes in radiographs .
9. Having no history of painkillers administrated with 12 hours before procedure.
|
|
| ExclusionCriteria |
| Details |
1. Teeth with crown/root fractures
2. Acute or chronic apical abscess
3. Pulp necrosis
4. Compromised periodontium and open apices
5. Allergic to NSAIDs
6. Pregnant or lactating women
7. Previously treated/initiated root canal treatment
8. Retreatment cases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of postoperative pain after premedication with three different anti-inflammatory drugs in single-visit root canal treatment for patients diagnosed with symptomatic irreversible pulpitis. |
6hr 12hr 24hr 48hr 72hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of postoperative pain after premedication with three different anti-inflammatory drugs in single-visit root canal treatment for patients diagnosed with symptomatic irreversible pulpitis
To analyse the effect of postoperative pain after premedication with three different anti-inflammatory drugs in single-visit root canal treatment for patients diagnosed with symptomatic irreversible pulpitis.
|
6hr 12hr 24hr 48hr 72hr |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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)
|
09/08/2025 |
| 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="6"
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
|
The present
clinical study will be a single blinded Patient will be blinded prospective
randomized controlled trial
A
total of 57 participants, who are actively seeking treatment and care at the
study hospital, will be chosen through a convenience sampling approach These
individuals must provide their consent to participate and meet the specified
eligibility criteria The selected sample will then
be randomly allocated into three equal groups with each subgroup containing
n 19 participants.
|