Impact of Intracanal Cryotherapy and Corticosteroids on Post Endodontic Pain

NCT07676396 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RecIM122411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study: is to evaluate efficiency of using either intracanal corticosteroids or intracanal cryotherapy as a final flush irrigation on post endodontic pain in lower molar teeth with symptomatic irreversible pulpitis. The materials and methods: In this study forty patients with symptomatic irreversible pulpitis in lower molar teeth with pain level of 4 or higher on the visual analogue scale (VAS) will be selected.

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Keywords

pain; cryotherapy; postoperative pain; dexamethasone; cold saline

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  assessment of post operative pain after single visit root canal treatment using vasual analogue scale

  1 year

Study Arms (5)

Saline at room temperature

NO INTERVENTION

After completing a cleaning and shaping and before obturation the canal rinsed with saline 20 ml for 5 min at room temperature with side vented needle

Sodium hypochlorite at room temperature

NO INTERVENTION

After completing a cleaning and shaping and before obturation the canal rinsed with sodium hypochlorite 20 ml for 5 min at room temperature with side vented needle

dexamethasone group

OTHER

intra root canal final flush of 5ml of 4mg/ml dexamethasone before obturation

Drug: dexamethasone

cold saline

OTHER

intra root canal final flush of 20ml of cold saline before obturation

Other: Cold Saline

cold Sodium hypochlorite

OTHER

intra root canal final flush of 20ml of cold sodium hypochlorite before obturation

Other: cold sodium hypochlorite

Interventions

dexamethasone DRUG

intra root canal final flush of 5ml of 4mg/ml dexamethasone before obturation

dexamethasone group

Cold Saline OTHER

intra root canal final flush of 20ml of cold saline before obturation

cold saline

cold sodium hypochlorite OTHER

intra root canal final flush of 20ml of cold sodium hypochlorite before obturation

cold Sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both gender -
• age range of (18-60 years ) -medical free patients with lower molars with symptomatic irreversible pulpitis and indicated for single visit root canal treatment with pain score 4 or more on VAS- Patients that commit for the entire period of the trial and agreed to sign the informed consent .

You may not qualify if:

• vulnerable group -teeth with open apex or calcified canals-curved canals-
• patients on analgesics or antibiotics
• periodontaly affected tooth

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 university

Giza, Egypt

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant, Faculty of Dentistry, October 6 university

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

EG (1)