ClinicalTrials.gg
Not yet recruitingNCT07738302Updated Jul 31, 2026

Assessment of Post-Operative Pain After Using Cryotherapy and Dexamethasone

An interventional study of cold NaOCl , dexamethasone and NaOCl, dexamethasone in Post Operative Pain, sponsored by Suez Canal University. Not yet recruiting. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Suez Canal University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post Operative Pain

Browse trials for

03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Suez Canal University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Medically free Patients. ( and II)
  • Age between 20-50 years old.
  • Males \& Females.
  • Patients' acceptance for participating in the trial through an (Appendix I)
  • Diagnosed clinically and radiographically with symptomatic irreversible pulpitis with apical peridontitits
  • No periapical radiolucency
  • Patent canals with n

Exclusion criteria

Exclusion Criteria:

Non restorable teeth.

  • No bleeding upon conducting access preparation.
  • Teeth presenting with:
  • History of trauma or previous endodontic treatment
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    cold NaOCl , dexamethasone

    for 1st visit and cold saline as final rinse for 2nd visit

    Combination Product: cold NaOCl , dexamethasone

  • Experimental
    NaOCl, dexamethasone

    for 1st visit and saline as final rinse for 2nd visit (room temperature)

    Combination Product: NaOCl, dexamethasone

  • Experimental
    cold NaOCl and cold saline

    for both visits final rinse for 2nd visit

    Combination Product: cold NaOCl and cold saline

  • Active comparator
    NaOCl and saline

    for both visits final rinse for 2nd visit (room temperature)

    Combination Product: NaOCl and saline

Interventions

  • Combination productcold NaOCl , dexamethasone

    irrigation solution

  • Combination productNaOCl, dexamethasone

    irrigation solution

  • Combination productcold NaOCl and cold saline

    irrigation solution

  • Combination productNaOCl and saline

    irrigation solution

06

What researchers measure

Primary outcomes

  1. post-operative pain

    VAS scale (visual analogue scale)

    Time frame: 7 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Sep 2026, 1 month later.

Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 1 month is below that.

Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2026
First posted
Jul 31, 2026
StartEst.
Aug 2026
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2026
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07738302
Responsible party
Tamer Abdel Rahman Mahmoud (PhD candidate, Suez Canal University) — Principal investigator
First posted
Jul 31, 2026
Start date
Aug 2026 (estimated)
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jul 31, 2026

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Dexamethasone

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