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

Phase 1

Not yet recruiting

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2023/06/054580
• Lead Sponsor: DrUnnati Sanjay Shah

Brief Summary

·        Prior permission from the institutional ethicscommittee will be taken and patients will be selected as per the inclusion andexclusion criteria after getting the permission and CTRI registration number.The patients will be informed about the study and the informed consent will betaken. All the treatment will be performed by the principal investigator. Patients within age of 18 and 65 years having maxillary or mandibular single rootedteeth with sharp pain upon thermal stimulus,lingering pain (often30 seconds or longer after stimulus removal), spontaneity (unprovoked pain) and referredpain, pain that getsaccentuated by postural changes and over-the-counter analgesics are typicallyineffective with no periapicalchanges on radiographic examination will bethe diagnostic criteria for Symptomatic Irreversible Pulpitis. The participants who met the inclusioncriteria will be randomly assigned to 3 groups based on the type of prescribeddrug, 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)* GroupII:- Diclofenac Sodium 100 mg (Tab. Voltaren) *(Novarits India Ltd)* .Allocation will be concealed by using darkcoded envelope containing the drug and will be given to each participant. Theenvelopes will be opened by an assistant not involved in the study, only whenthe pill is going to be taken. The participants, the researcher, and thestatistician will be blinded to the type of drug. The envelope codes will beonly mentioned on the participants’ special information sheets whileprescribing. Then, the cold test and EPT will beperformed on a tooth with healthy pulp from the contralateral quadrant as wellas the adjacent tooth and then on the tooth with SIP. The respective tooth will be dried andisolated by cotton rolls to perform the cold test. Endo-Frost cold spray willbe sprayed over a cotton applicator for 3– 5 seconds and immediately placed onthe 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 torate their level of pain after the cold test using a VAS with the left endshowing no pain at all and the right end indicating maximum imaginable pain. An electric pulp tester will be used forthe EPT. For this purpose, the tooth will be isolated with cotton rolls toensure the accuracy of the EPT readings. The lip clip will be attached to theopposite side of the tooth and the tip of the probe will be placed on theincisal third of the buccal surface after being impregnated with theprophylaxis paste. Then the pulp tester will be turned on and the intensitywill be gradually increased. The participants are asked to notify the clinicianas soon as they felt pain, burning sensation, or heat. The level displayed bythe pulp tester at that moment will be recorded. After pain assessment, the envelopescontaining will be given to the participants, and the cold test and EPT will beperformed on the same teeth by the same method at 20-minute intervals for 60minutes. All values will be recorded by the researcher. All tests will be performedon all participants by a single operator.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-28
• Study Start: 2023-10-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
effect of analgesic on the responses of the pulp sensibility test in irreversible pulpitis cases	30 mins

Secondary Outcome Measures

Name	Time	Method
Effect of analgesics on response of pulp sensibility test	60, 90 mins

Trial Locations

Locations (1)

K M Shah Dental College & Hospital; 🇮🇳 Vadodara, GUJARAT, India

K M Shah Dental College & Hospital

🇮🇳Vadodara, GUJARAT, India

DrUnnati Sanjay Shah

Principal investigator

8390776669

shahunnati2014@gmail.com