| CTRI Number |
CTRI/2022/07/044231 [Registered on: 21/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Research comparing the effect of transdermal patches of ketoprofen and diclofenac sodium to that of oral diclofenac sodium tablets on pain reduction following single-visit root canal therapy in patients with symptomatic irreversible pulpitis - a randomized clinical trial |
|
Scientific Title of Study
|
“Comparative evaluation of efficiency of
transdermal patches of ketoprofen and diclofenac
sodium with oral diclofenac tablet on post
endodontic pain reduction following single visit
root canal therapy in symptomatic irreversible
pulpitis- A Randomized Clinical Study.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Porwal |
| Designation |
Post graduate student |
| Affiliation |
K.M.Shah dental college and hospital |
| Address |
Room No 8, Department of conservative dentistry and endodontics, K M Shah dental college and hospital, piparia
Vadodara
GUJARAT
391760
India |
| Phone |
07899744426 |
| Fax |
|
| Email |
piyajain4695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Shah |
| Designation |
Professor and Head of the department |
| Affiliation |
K. M. Shah dental college and hospital |
| Address |
Room No 8, Department of conservative dentistry and endodontics, K M Shah dental college and hospital, piparia
Vadodara
GUJARAT
391760
India |
| Phone |
09998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Porwal |
| Designation |
Post graduate student |
| Affiliation |
K. M. Shah dental college and hospital |
| Address |
Room No 8, Department of conservative dentistry and endodontics, K M Shah dental college and hospital, piparia
Vadodara
GUJARAT
391760
India |
| Phone |
07899744426 |
| Fax |
|
| Email |
piyajain4695@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah dental college and hospital, sumandeep vidyapeeth university, piparia, Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
DR PRIYA PORWAL |
| Address |
darshani jewellers, saraf bazar, bijapur, karnataka |
| 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 |
| DR PRIYA PORWAL |
K M Shah dental college and hospital |
Room no 8 department of conservative dentistry and endodontics, K.M.Shah dental college and hospital, piparia
Vadodara
GUJARAT |
07899744426
piyajain4695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethics 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 |
| Comparator Agent |
diclofenac sodium |
50mg diclofenac sodium tablet orally, twice a day for 2 days |
| Intervention |
diclofenac sodium |
zuventus healthcare Ltd, analgesic transdermal patches 100mg one patch per day for two days |
| Intervention |
ketoprofen |
zuventus healthcare Ltd, analgesic transdermal patch 30mg one patch per day for two days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients complaining of pain in anterior or single-rooted premolar teeth of either jaw
and diagnosed as symptomatic irreversible pulpitis with or without apical periodontitis
having pre operative moderate to severe pain indicated for single visit endodontics will
be included in the study.
A written informed consent will be taken from all the patients and only those patients
ready to sign the consent letter will be included in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity against ketoprofen or diclofenac sodium will be excluded from the study.
2. patients with history of allergic reactions such as bronchospasm, shock, urticarial,
etc., following the use of non-steroidal anti-inflammatory drugs (NSAIDs) will be excluded from the study.
3. Patients with high blood pressure and cardiac conditions will be excluded from the study.
4. Patients with sinus drainage, pus discharge, acute or chronic apical abscess will be excluded from the study.
5. Intentional RCT, fractured tooth having cracks or resorption will be excluded from
the study.
6. Patients with active stomach or duodenal ulceration within the last 6 months will be excluded from the study.
7. Patients undergoing treatment with other NSAIDs or corticosteroids during the
study period will be excluded from the study.
8. Patients with developmental anomalies, congenital defects, pathology or open apex,
with presence of anatomical obstacles such as calcifications in the canals or any
anticipated procedural difficulties related to study teeth will be excluded from the study.
9. Pregnant and lactating women will be excluded from the study.
10. Patients who have taken NSAIDS or antibiotics within 24 hrs before administration
of study drug will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| as a outcome of the study, postoperative pain control will be assessed at 4hours, 8hours, 24hours and 48hours after the treatment |
4hours, 8hours, 24hours and 48hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| as a secondary outcome of the study adverse effects of transdermal pain relieving patches and oral analgesics will be assessed during the course of the study i.e., 48h |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="78" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2022 |
| Date of Study Completion (India) |
26/10/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is conducted to compare the efficacy of ketoprofen and diclofenac sodium transdermal patches with that of oral diclofenac sodium tablets on post-operative pain reduction after single sitting root canal therapy in patients having symptomatic irreversible pulpitis. Results of the study will enable us to determine which route of drug delivery is most
effective and how effective transdermal patches are in controlling pain. Transdermal
patches minimize or eliminate side effects like gastric discomfort and irritation caused
by oral medication. In addition to evaluating the most effective NSAID in controlling
post-operative pain after root canal treatment, this study will also help us evaluate the
side effects caused by transdermal patches. |