Symptomatic Irreversible Pulpitis (SIP)Phase 4NCT07676396
Impact of Intracanal Cryotherapy and Corticosteroids on Post Endodontic Pain
A Phase 4 study testing dexamethasone, Cold Saline and cold sodium hypochlorite in people with Symptomatic Irreversible Pulpitis (SIP), run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- dexamethasone, Cold Saline and cold sodium hypochlorite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- vulnerable group -teeth with open apex or calcified canals-curved canals-
- patients on analgesics or antibiotics
- periodontaly affected tooth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- dexamethasone, Cold Saline, cold sodium hypochlorite
- Keywords
- pain, cryotherapy, postoperative pain, dexamethasone, cold saline
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
intra root canal final flush of 5ml of 4mg/ml dexamethasone before obturation
Cold SalineOther
intra root canal final flush of 20ml of cold saline before obturation
cold sodium hypochloriteOther
intra root canal final flush of 20ml of cold sodium hypochlorite before obturation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: dexamethasone |
| cold saline | Other | intra root canal final flush of 20ml of cold saline before obturation Receives: Other: Cold Saline |
| cold Sodium hypochlorite | Other | intra root canal final flush of 20ml of cold sodium hypochlorite before obturation Receives: Other: cold sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
assessment of post operative pain after single visit root canal treatment using vasual analogue scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Apr 2025
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mamoud Haggag Zaki, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676396
- Sponsor's protocol ID
- FDASU-RecIM122411
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency Of Intracanal Cryotherapy Versus Corticosteroids As Final Irrigation On Post Operative Pain Level In Patients With Symptomatic Irreversible Pulpitis Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07676396
- Acronym / sponsor ID
- FDASU-RecIM122411
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Keywords
- pain, cryotherapy, postoperative pain, dexamethasone, cold saline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: dexamethasoneintra root canal final flush of 5ml of 4mg/ml dexamethasone before obturation |
| cold saline | Other | Other: Cold Salineintra root canal final flush of 20ml of cold saline before obturation |
| cold Sodium hypochlorite | Other | Other: cold sodium hypochloriteintra root canal final flush of 20ml of cold sodium hypochlorite before obturation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (3 listed)
- vulnerable group -teeth with open apex or calcified canals-curved canals-
- patients on analgesics or antibiotics
- periodontaly affected tooth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasoneintra root canal final flush of 5ml of 4mg/ml dexamethasone before obturation | Drug | dexamethasone group |
| Cold Salineintra root canal final flush of 20ml of cold saline before obturation | Other | cold saline |
| cold sodium hypochloriteintra root canal final flush of 20ml of cold sodium hypochlorite before obturation | Other | cold Sodium hypochlorite |
Primary outcome
postoperative pain
Time frame: 1 year
assessment of post operative pain after single visit root canal treatment using vasual analogue scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone, Cold Saline and cold sodium hypochlorite in people with Symptomatic Irreversible Pulpitis (SIP), run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.