Cryotherapy Versus Dexamethasone on Postoperative Pain in Permanent Mandibular Molars

NCT ID: NCT06832254

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-05

Study Completion Date

2025-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of normal saline for 5 minutes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Cryotherapy Group

Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA and finally all canals were irrigated with a total of 20 mL of cold (2 °C) saline for 5 minutes.

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

The root canals were irrigated with 2 °C saline solution in final irrigation in cryotherapy group.

Dexamethasone Group

Irrigation was performed with a 30 G navitip needle and 2.5% sodium hypochlorite (NaOCl). A total of 11 mL of NaOCl was used in each root canal, 2 mL after coronal preparation, 2 mL after middle third preparation, 2 mL after apical third preparation and 5 mL in the final irrigation. After irrigation with NaOCl, each root canal was irrigated with 2 mL saline, 2 mL 17% EDTA, 2 mL saline and 1 mL dexamethasone.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Each root canal was irrigated with 1 mL dexamethasone solution in final irrigation in dexamethasone group.

Interventions

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Cryotherapy

The root canals were irrigated with 2 °C saline solution in final irrigation in cryotherapy group.

Intervention Type OTHER

Dexamethasone

Each root canal was irrigated with 1 mL dexamethasone solution in final irrigation in dexamethasone group.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Kübra Gürler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koray Yılmaz, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Cukurova University

Locations

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Cukurova University

Adana, Sarıçam, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 10530266 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38600937 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38576278 (View on PubMed)

Other Identifiers

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13.02.2025/151

Identifier Type: -

Identifier Source: org_study_id

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