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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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