Post Operative PainNCT07738302
Assessment of Post-Operative Pain After Using Cryotherapy and Dexamethasone
A study testing cold NaOCl , dexamethasone, NaOCl, dexamethasone and cold NaOCl and cold saline in people with Post Operative Pain, run by Suez Canal University.
Trial summary
Evaluation and comparing the effect of cryotherapy and dexamethasone on inflammatory mediators and post-operative pain in symptomatic irreversible pulpitis with acute apical periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- cold NaOCl , dexamethasone, NaOCl, dexamethasone and cold NaOCl and cold saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically free Patients. (ASA I and II)
- Age between 20-50 years old.
- Males \& Females.
- Patients' acceptance for participating in the trial through an informed consent (Appendix I)
- Diagnosed clinically and radiographically with symptomatic irreversible pulpitis with apical peridontitits
- No periapical radiolucency
- Patent canals with n
Who cannot join
- Non restorable teeth.
- No bleeding upon conducting access preparation.
- Teeth presenting with:
- History of trauma or previous endodontic treatment
About this study
Official title: Assessment of Post-Operative Pain After Using Cryotherapy and Dexamethasone in Symptomatic Irreversible Pulpitis With Acute Apical Periodontitis: A Randomized Clinical Trial.
Evaluation and comparing the effect of cryotherapy and dexamethasone on inflammatory mediators and post-operative pain in symptomatic irreversible pulpitis with acute apical periodontitis.
Read the detailed description
sixty patients with single root teeth diagnosed with symptomatic irreversible pulpitis with acute apical periodontitis will be treated in two visits with time interval 72 hrs. Later, they will be randomized into four groups according to the type of irrigant used, group (A): (cold NaOCl , dexamethasone) for 1st visit and cold saline as final rinse for 2nd visit, group (B): ( NaOCl, dexamethasone) for 1st visit and saline as final rinse for 2nd visit (room temperature), group (C): cold NaOCl and cold saline and group D: NaOCl and saline room temperature as control group. Each group will be prepared with trunatomy rotary files according to manufactures instruction. Inflammatory mediators IL-8 and substance P will be assessed by absorbent paper points after access preparation and before obturation using ELISA test. Post-operative pain will be measured after first visit at 6,12, 24,48,72 hrs. then after second visit at 12,24,48,72hrs and 7 days using the visual analogue scale.
- Conditions
- Post Operative Pain
- Being tested
- cold NaOCl , dexamethasone, NaOCl, dexamethasone, cold NaOCl and cold saline, NaOCl and saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold NaOCl , dexamethasoneCombination product
irrigation solution
NaOCl, dexamethasoneCombination product
irrigation solution
cold NaOCl and cold salineCombination product
irrigation solution
NaOCl and salineCombination product
irrigation solution
| Study group | Role | What they receive |
|---|---|---|
| cold NaOCl , dexamethasone | Experimental | for 1st visit and cold saline as final rinse for 2nd visit Receives: Combination Product: cold NaOCl , dexamethasone |
| NaOCl, dexamethasone | Experimental | for 1st visit and saline as final rinse for 2nd visit (room temperature) Receives: Combination Product: NaOCl, dexamethasone |
| cold NaOCl and cold saline | Experimental | for both visits final rinse for 2nd visit Receives: Combination Product: cold NaOCl and cold saline |
| NaOCl and saline | Active comparator | for both visits final rinse for 2nd visit (room temperature) Receives: Combination Product: NaOCl and saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
VAS scale (visual analogue scale)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Abdel Rahman Mahmoud, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738302
- Sponsor's protocol ID
- TM-7-2026
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 31 Jul 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Post-Operative Pain After Using Cryotherapy and Dexamethasone in Symptomatic Irreversible Pulpitis With Acute Apical Periodontitis: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07738302
- Acronym / sponsor ID
- TM-7-2026
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 31 Jul 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.
Evaluation and comparing the effect of cryotherapy and dexamethasone on inflammatory mediators and post-operative pain in symptomatic irreversible pulpitis with acute apical periodontitis.
Detailed description
sixty patients with single root teeth diagnosed with symptomatic irreversible pulpitis with acute apical periodontitis will be treated in two visits with time interval 72 hrs. Later, they will be randomized into four groups according to the type of irrigant used, group (A): (cold NaOCl , dexamethasone) for 1st visit and cold saline as final rinse for 2nd visit, group (B): ( NaOCl, dexamethasone) for 1st visit and saline as final rinse for 2nd visit (room temperature), group (C): cold NaOCl and cold saline and group D: NaOCl and saline room temperature as control group. Each group will be prepared with trunatomy rotary files according to manufactures instruction. Inflammatory mediators IL-8 and substance P will be assessed by absorbent paper points after access preparation and before obturation using ELISA test. Post-operative pain will be measured after first visit at 6,12, 24,48,72 hrs. then after second visit at 12,24,48,72hrs and 7 days using the visual analogue scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cold NaOCl , dexamethasone | Experimental | Combination Product: cold NaOCl , dexamethasonefor 1st visit and cold saline as final rinse for 2nd visit |
| NaOCl, dexamethasone | Experimental | Combination Product: NaOCl, dexamethasonefor 1st visit and saline as final rinse for 2nd visit (room temperature) |
| cold NaOCl and cold saline | Experimental | Combination Product: cold NaOCl and cold salinefor both visits final rinse for 2nd visit |
| NaOCl and saline | Active comparator | Combination Product: NaOCl and salinefor both visits final rinse for 2nd visit (room temperature) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Medically free Patients. (ASA I and II)
- Age between 20-50 years old.
- Males \& Females.
- Patients' acceptance for participating in the trial through an informed consent (Appendix I)
- Diagnosed clinically and radiographically with symptomatic irreversible pulpitis with apical peridontitits
Key exclusion criteria (4 listed)
- Non restorable teeth.
- No bleeding upon conducting access preparation.
- Teeth presenting with:
- History of trauma or previous endodontic treatment
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 |
|---|---|---|
| cold NaOCl , dexamethasoneirrigation solution | Combination product | cold NaOCl , dexamethasone |
| NaOCl, dexamethasoneirrigation solution | Combination product | NaOCl, dexamethasone |
| cold NaOCl and cold salineirrigation solution | Combination product | cold NaOCl and cold saline |
| NaOCl and salineirrigation solution | Combination product | NaOCl and saline |
Primary outcome
post-operative pain
Time frame: 7 days
VAS scale (visual analogue scale)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Related trials for Post Operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cold NaOCl , dexamethasone, NaOCl, dexamethasone and cold NaOCl and cold saline in people with Post Operative Pain, run by Suez Canal University.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
post-operative pain (time frame: 7 days). 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 31 Jul 2026.