CTRI Number |
CTRI/2023/06/054580 [Registered on: 30/06/2023] Trial Registered Prospectively |
Last Modified On: |
28/06/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To evaluate and compare the effect of pain killers (Ketorolac & Diclofenac Sodium) on the responses of Pulpal Sensibility tests in patients with symptomatic irreversible pulp inflammation A Randomized Clinical Study |
Scientific Title of Study
|
Comparatively Evaluation of the Effect of Two Analgesics (Ketorolac & Diclofenac Sodium) on the responses of Pulpal Sensibility tests in patients with 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 |
Unnati Sanjay Shah |
Designation |
Post Graduate |
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,Waghodia,Pipariya, Vadodara 391760
Vadodara GUJARAT 391760 India |
Phone |
08830438229 |
Fax |
|
Email |
shahunnati2014@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Ajay Singh Rao |
Designation |
Professor |
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,Waghodia,Pipariya, Vadodara 391760
Vadodara GUJARAT 391760 India |
Phone |
|
Fax |
|
Email |
drajayinendo@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Unnati Sanjay Shah |
Designation |
Post Graduate |
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,Waghodia,Pipariya, Vadodara 391760
Vadodara GUJARAT 391760 India |
Phone |
08830438229 |
Fax |
|
Email |
shahunnati2014@gmail.com |
|
Source of Monetary or Material Support
|
Room no 8, Department of Conservative Dentistry and Endodontics,K M Shah DEntal College and Hospital,Waghodia,Pipariya, Vadodara 391760 |
|
Primary Sponsor
|
Name |
DrUnnati Sanjay Shah |
Address |
Room no.8, Dept of Conservative Dentistry and Hospital, K.M.Shah Dental College and Hospital,Sumanpeeth Vidyapeeth,Pipariya,Waghodia |
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 |
DrUnnati Sanjay Shah |
K M Shah Dental College & Hospital |
Room no.8, Dept of Conservative Dentistry and Hospital, K.M.Shah Dental College and Hospital,Sumanpeeth Vidyapeeth,Pipariya,Waghodi Vadodara GUJARAT |
8390776669
shahunnati2014@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sumandeep Vidyapeeth Institutional Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Diclofenac sodium |
A pre-operative scores will be taken of the pulp sensibility test and patient will be given keterolac 10 mg orally followed by the pulp sensibility test will be done at 30,60,90 minutes thus followed by post-operative scores. |
Intervention |
Keterolac |
A pre-operative scores will be taken of the pulp sensibility test and patient will be given keterolac 10 mg orally followed by the pulp sensibility test will be done at 30,60,90 minutes thus followed by post-operative scores. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Patients with Symptomatic Irreversible Pulpitis in permanent teeth will be included in the study.
2. Patients with no history of any analgesic or central nervous system depressant intake in the past 24 hours prior to their visit will be included in the study.
3. A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study.
|
|
ExclusionCriteria |
Details |
1. Teeth with secondary caries will be excluded
2. Teeth with compromised periodontal health will be excluded.
3. Medically compromised patients will be excluded.
4. Teeth with open apex will be excluded.
5. Teeth with root resorption will be excluded.
6. Teeth indicated for endodontic re- treatment will be excluded.
7. Teeth with vertical root fractures will be excluded.
8. Pregnant and lactating women will be excluded.
9. Patients allergic to analgesics, with gastrointestinal disorders will be excluded in the study.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
effect of analgesic on the responses of the pulp sensibility test in irreversible pulpitis cases |
30 mins |
|
Secondary Outcome
|
Outcome |
TimePoints |
Effect of analgesics on response of pulp sensibility test |
60, 90 mins |
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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 1 |
Date of First Enrollment (India)
|
10/07/2023 |
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="0" Months="3" 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
|
·
Prior permission from the institutional ethics
committee will be taken and patients will be selected as per the inclusion and
exclusion criteria after getting the permission and CTRI registration number.
The patients will be informed about the study and the informed consent will be
taken. All the treatment will be performed by the principal investigator. Patients within age of 18 and 65 years having maxillary or mandibular single rooted
teeth with sharp pain upon thermal stimulus,
lingering pain (often
30 seconds or longer after stimulus removal), spontaneity (unprovoked pain) and referred
pain, pain that gets
accentuated by postural changes and over-the-counter analgesics are typically
ineffective with no periapical
changes on radiographic examination will be
the diagnostic criteria for Symptomatic Irreversible Pulpitis. The participants who met the inclusion
criteria will be randomly assigned to 3 groups based on the type of prescribed
drug, including by using a table of computer-generated random numbers (www.
randomization.com).Group I:-
Ketorolac 10 mg (Tab.Ketorol DT) (Dr.Reddy’s Laboratories Ltd) Group
II:- Diclofenac Sodium 100 mg (Tab. Voltaren) (Novarits India Ltd) .Allocation will be concealed by using dark
coded envelope containing the drug and will be given to each participant. The
envelopes will be opened by an assistant not involved in the study, only when
the pill is going to be taken. The participants, the researcher, and the
statistician will be blinded to the type of drug. The envelope codes will be
only mentioned on the participants’ special information sheets while
prescribing. Then, the cold test and EPT will be
performed on a tooth with healthy pulp from the contralateral quadrant as well
as the adjacent tooth and then on the tooth with SIP. The respective tooth will be dried and
isolated by cotton rolls to perform the cold test. Endo-Frost cold spray will
be sprayed over a cotton applicator for 3– 5 seconds and immediately placed on
the sound buccal surface of the respective tooth for a maximum of 15 seconds.
Cold sensitivity will be recorded by a 10 mm visual analogue scale (VAS)
(previously instructed to the participants). The participants will be asked to
rate their level of pain after the cold test using a VAS with the left end
showing no pain at all and the right end indicating maximum imaginable pain. An electric pulp tester will be used for
the EPT. For this purpose, the tooth will be isolated with cotton rolls to
ensure the accuracy of the EPT readings. The lip clip will be attached to the
opposite side of the tooth and the tip of the probe will be placed on the
incisal third of the buccal surface after being impregnated with the
prophylaxis paste. Then the pulp tester will be turned on and the intensity
will be gradually increased. The participants are asked to notify the clinician
as soon as they felt pain, burning sensation, or heat. The level displayed by
the pulp tester at that moment will be recorded. After pain assessment, the envelopes
containing will be given to the participants, and the cold test and EPT will be
performed on the same teeth by the same method at 20-minute intervals for 60
minutes. All values will be recorded by the researcher. All tests will be performed
on all participants by a single operator. |