- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07676396
Impact of Intracanal Cryotherapy and Corticosteroids on Post Endodontic Pain
June 24, 2026 updated by: Mamoud Haggag Zaki, October 6 University
Efficiency Of Intracanal Cryotherapy Versus Corticosteroids As Final Irrigation On Post Operative Pain Level In Patients With Symptomatic Irreversible Pulpitis Randomized Control Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Giza, Egypt
- October 6 university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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:
- vulnerable group -teeth with open apex or calcified canals-curved canals-
- patients on analgesics or antibiotics
- periodontaly affected tooth
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
intra root canal final flush of 5ml of 4mg/ml dexamethasone before obturation
|
|
Other: cold saline
intra root canal final flush of 20ml of cold saline before obturation
|
intra root canal final flush of 20ml of cold saline before obturation
|
|
Other: cold Sodium hypochlorite
intra root canal final flush of 20ml of cold sodium hypochlorite before obturation
|
intra root canal final flush of 20ml of cold sodium hypochlorite before obturation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative pain
Time Frame: 1 year
|
assessment of post operative pain after single visit root canal treatment using vasual analogue scale
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
March 1, 2026
Study Registration Dates
First Submitted
June 24, 2026
First Submitted That Met QC Criteria
June 24, 2026
First Posted (Actual)
June 30, 2026
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 24, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDASU-RecIM122411
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Symptomatic Irreversible Pulpitis (SIP)
-
Future University in EgyptActive, not recruitingSymptomatic Irreversible Pulpitis (SIP)Egypt
-
Tehran University of Medical SciencesActive, not recruitingSymptomatic Irreversible Pulpitis (SIP) | Symptomatic Irreversible Pulpitis With Apical PeridontitisIran
-
Dow University of Health SciencesRecruitingSymptomatic Irreversible Pulpitis (SIP)Pakistan
-
Cairo UniversityCompletedSymptomatic Irreversible Pulpitis (SIP)Egypt
-
Ondokuz Mayıs UniversityRecruitingSymptomatic Irreversible Pulpitis (SIP)Turkey (Türkiye)
-
Cairo UniversityNot yet recruitingSymptomatic Irreversible Pulpitis (SIP)Egypt
-
University of FujairahRecruitingSymptomatic Irreversible Pulpitis | Symptomatic Irreversible Pulpitis (SIP)United Arab Emirates
-
Cumhuriyet UniversityCompletedSymptomatic Irreversible Pulpitis (SIP)Turkey (Türkiye)
-
Future University in EgyptActive, not recruitingSymptomatic Irreversible Pulpitis (SIP)Egypt
-
Zahoor khanHITEC-Institute of Medical SciencesCompletedEvaluating the Combined Effect of Oral Premedications on Inferior Alveolar Nerve Block EffectivenessSymptomatic Irreversible PulpitisPakistan
Clinical Trials on dexamethasone
-
Poznan University of Medical SciencesRecruitingHip Pain Chronic | Hip OsteoarthritisPoland
-
Beijing Tiantan HospitalBeijing Ditan Hospital; Beijing Electric Power HospitalNot yet recruiting
-
Poznan University of Medical SciencesNot yet recruitingOsteoarthritis, Hip | Hip OsteoarthritisPoland
-
TheiaNova Ltd.Enrolling by invitation
-
Woman'sRecruitingOral Mucositis Due to ChemotherapyUnited States
-
Shandong UniversityRecruitingPrimary Immune Thrombocytopenia (ITP)China
-
Semnur Pharmaceuticals, Inc.Cromos Pharma LLC; SyngeneNot yet recruitingLumbosacral Radicular Pain
-
Sheffield Children's NHS Foundation TrustRecruitingDexamethasone | Acute AsthmaUnited Kingdom
-
Second Affiliated Hospital, School of Medicine,...West China Hospital; Ningbo Medical Center Lihuili Hospital; Jinhua People's... and other collaboratorsRecruitingInflammatory Bowel Disease (IBD) | UC - Ulcerative Colitis | CD - Crohn's DiseaseChina
-
Eye & ENT Hospital of Fudan UniversityShanghai Zhongshan Hospital; Shenzhen Second People's HospitalNot yet recruiting