Clinical trial NCT06832254: Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars
Official title: Effectiveness of Cryotherapy Versus Dexamethasone on Reducing Postoperative Pain in Permanent Mandibular Molars with Irreversible Pulpitis: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Cryotherapy
Irrevesible pulpitis
Dexamethasone
Postoperative pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial was to evaluate cryotherapy versus dexamethasone on the intensity of postoperative pain in root canal treatment procedures in mandibular first molar teeth with symptomatic irreversible pulpitis. The main question it aims to answer is:

* Does controlled irrigation with cold saline in root canal treatment reduce the severity of postoperative pain?
* Does controlled irrigation with dexamethasone in root canal treatment reduce the severity of postoperative pain? In the cryotherapy group, unlike the control and dexamethasone group, the root canals were irrigated with 2 °C salin solution in final irrigation.

In the dexamethasone group, unlike the control and cryotherapy group, the root canals were irrigated with 1 mL dexamethasone solution in final irrigation.


Eligibility criteria: Inclusion Criteria:

* Vital mandibular first and second molars with 3 root canals that responded positively to the cold test and electric pulp test
* Patients who had not taken analgesics or antibiotics in the last 24 hours before the procedure were included in the study.

Exclusion Criteria:

* Devital mandibular first and second molars that responded negatively to cold tests and electric pulp tests
* Mandibular first and second molars with poor periodontal status (pocket depth \> 4 mm),
* Mandibular first and second molars with 4 or more root canals detected radiographically or after opening the endodontic access cavity were excluded from the study.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıçam
Study officials:
affiliation: Cukurova University
name: Koray Yılmaz, DDS MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers MJ, Johnson BR, Remeikis NA, BeGole EA. Comparison of effect of intracanal use of ketorolac tromethamine and dexamethasone with oral ibuprofen on post treatment endodontic pain. J Endod. 1999 May;25(5):381-4. doi: 10.1016/S0099-2399(06)81176-3.
citation: Solomon RV, Paneeru SP, Swetha C, Yatham R. Comparative evaluation of effect of intracanal cryotherapy and corticosteroid solution on post endodontic pain in single visit root canal treatment. J Clin Exp Dent. 2024 Mar 1;16(3):e250-e256. doi: 10.4317/jced.61023. eCollection 2024 Mar.
citation: Dildar I, Moghal A, Mirza A, Zaheer MA, Mallick MR, Munir S. Evaluation of Postoperative Pain after Using Dexamethasone Intracanal Rinse in Irreversible Pulpitis. J Coll Physicians Surg Pak. 2024 Apr;34(4):390-393. doi: 10.29271/jcpsp.2024.04.390.