CClinicalTrials.gg
CompletedNCT07676396Updated Jun 30, 2026

Impact of Intracanal Cryotherapy and Corticosteroids on Post Endodontic Pain

A Phase 4 interventional study of dexamethasone and Cold Saline in Symptomatic Irreversible Pulpitis (SIP), sponsored by October 6 University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by October 6 University · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2025, registered Jun 2026).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

This study will involve 40 adult patients (18-60 years) for both genders equally .all of patients must provide written informed consent and commit to the full trial period. Eligible participants must present with a lower molar diagnosed with symptomatic irreversible pulpitis, characterized by moderate-to-severe preoperative pain (VAS score ≥ 4) that lingers after stimulus removal. Conversely, the study excludes vulnerable groups (e.g., pregnant or mentally ill), medically compromised individuals, and those who have taken analgesics or antibiotics. Specific dental exclusions include teeth with open apices, calcified canals, prior endodontic treatment, or periodontally affected tooth

02

Conditions studied

  • Symptomatic Irreversible Pulpitis (SIP)

Keywords

  • pain
  • cryotherapy
  • postoperative pain
  • dexamethasone
  • cold saline
03

In context

Pain

2,219 studies on the registry are indexed under Pain; 915 are open to participants now.

This study's enrollment of 40 is below the median of 70 across 1,901 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

October 6 University is the lead sponsor of 135 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • vulnerable group -teeth with open apex or calcified canals-curved canals-
  • patients on analgesics or antibiotics
  • periodontaly affected tooth
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    Saline at room temperature

    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

  • No intervention
    Sodium hypochlorite at room temperature

    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

  • Other
    dexamethasone group

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

    Drug: dexamethasone

  • Other
    cold saline

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

    Other: Cold Saline

  • Other
    cold Sodium hypochlorite

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

    Other: cold sodium hypochlorite

Interventions

  • Drugdexamethasone

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

  • OtherCold Saline

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

  • Othercold sodium hypochlorite

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

06

What researchers measure

Primary outcomes

  1. postoperative pain

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

    Time frame: 1 year

07

Study locations

1 site
  • October 6 university
    Giza, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07676396
Lead sponsor
October 6 University
Responsible party
Mamoud Haggag Zaki (Teaching assistant, Faculty of Dentistry, October 6 university, October 6 University) — Principal investigator
First posted
Jun 30, 2026
Start date
Apr 1, 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026
Last update
Jun 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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