ClinicalTrials.gg
CompletedNCT07904312Updated Oct 29, 2026

Effect of Different Methods of Cryotherapy Applications on Postoperative Pain and Substance P Level in Patients With Acute Irreversible Pulpitis With Apical Periodontitis: A Randomized Controlled Trial

An interventional study of Extra-oral Cryotherapy and Intra-canal Cryotherapy in Irreversible Pulpitis and Apical Periodontitis, sponsored by Ahmad badrah. Completed at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Ahmad badrah · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Aug 2025, registered Oct 2026).
Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 37 studies in Periapical Periodontitis with a site in Egypt — 11 open to participants now, 16 under way, 2 of them phase 3. Periapical Periodontitis · Egypt.

Enrollment
22nd of 37
40 · median 45
Started
2025
with 6 others
No phase
30 of 37
8 open now
Registered
36th of 37
by date
Lead sponsor
1 of 37
Ahmad badrah

Among the 37 studies in Periapical Periodontitis with a site in Egypt, this one is the 22nd largest by enrollment, is one of 7 that started in 2025, is one of 30 with no phase, and was the 36th registered.

Periapical Periodontitis

280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.

Browse Periapical Periodontitis studies →

Open to participants now

11 of the 37 studies in Periapical Periodontitis with a site in Egypt are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 43 Periapical Periodontitis studies recruiting now, 17 (40%) set no upper age limit and 25 (58%) stop at 75 or younger; 5 take children under 18; 21 take healthy volunteers.

This study: 18 Years to 45 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

This randomized controlled clinical trial evaluates the effect of different methods of cryotherapy (extra-oral, intra-canal, and combination) on postoperative pain and periapical Substance P levels in patients with acute irreversible pulpitis and symptomatic apical periodontitis. Forty participants will be divided into four groups to compare the therapeutic benefits of cold applications in endodontic treatment

03

Conditions studied

  • Irreversible Pulpitis
  • Apical Periodontitis
04

Who can participate

Ages eligible
18 Years to 45 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

  • Candidates received a comprehensive explanation of the study, provided written , and agreed to complete the full trial.
  • Patients having lower molars with vital pulp \& irreversible pulpitis.
  • Patients with apical periodontitis were selected based on severe preoperative and percussion pain, defined as a visual analogue scale (VAS) score greater than 7.
  • The absence of periapical radiolucency on radiographs.

Exclusion criteria

Exclusion Criteria:

  • History of systemic disease.
  • Vulnerable population: prisoners, pregnant women, mentally ill people, etc.
  • Patients took analgesics before treatment
  • A radiographically calcified canal
  • A previous endodontic treatment
  • Sinus tracts
  • Local gingival inflammation around the offended tooth
  • Severe periodontal disease
  • Presence of periodontal pockets >3 mm in the affected tooth
  • No bleeding observed upon access cavity preparation
  • Inaccurate working length determination
  • Separated instruments, over instrumentation, and overfilling or under filling
  • Resorption
  • Periapical radiolucency
  • Anatomical variations as, excessively curved root or Prescence radix, excessively long or short roots,teeth with open apices
Terms in these criteria, in plain language(1)

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.

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
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Group I: Extra-oral Cryotherapy Group

    Patients will receive conventional root canal treatment accompanied by extra-oral cryotherapy application

    Procedure: Extra-oral Cryotherapy

  • Experimental
    Group II: Intra-canal Cryotherapy group

    Patients will receive conventional root canal treatment accompanied by intra-canal cryotherapy application

    Procedure: Intra-canal Cryotherapy

  • Experimental
    Group III: Combination Cryotherapy group

    Patients will receive conventional root canal treatment accompanied by both intra-canal and extra-oral cryotherapy application

    Procedure: Combination (extra-oral and intra-canal)

  • Active comparator
    Group IV: Control Group

    Conventional endodontic treatment without cryotherapy

    Procedure: Conventional Endodontic Treatment

Interventions

  • ProcedureExtra-oral Cryotherapy

    Application of extra-oral cold packs (on the cheek) for 30 minutes after the conventional root canal treatment

  • ProcedureIntra-canal Cryotherapy

    Application of intra-canal cold (2-4°C) 2.5% NaOCl irrigation after the conventional root canal treatment

  • ProcedureCombination (extra-oral and intra-canal)

    Received both extra-oral gel pack and intra-canal cold NaOCl applications (as previous) after the conventional root canal treatment

  • ProcedureConventional Endodontic Treatment

    Standard root canal treatment without the application of cryotherapy

06

What researchers measure

Primary outcomes

  1. Postoperative Pain

    Assessment of postoperative pain intensity using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at specific intervals

    Time frame: Measured at 6, 12, 24, and 48 hours and 1 week postoperatively

Secondary outcomes

  1. substance P (SP) Levels

    Evaluation of Substance P concentration in periapical tissue fluid as a biochemical marker for inflammation

    Time frame: Assessed immediately after the conventional root canal preparation, and subsequently after the application of cryotherapy for the experimental groups or after 30 minutes for the control group

07

Study locations

1 site
  • Ain Shams University hospital
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

1 registry update 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

Ran from Aug 2025 to primary completion in Feb 2026, 5 months.

Of 171 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's 5 months is below that.

Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 6 and three quarters within 19.

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

Registered
Oct 23, 2026
First posted
Oct 29, 2026
StartActual
Aug 29, 2025
Primary completionActual
Feb 10, 2026
CompletionActual
May 11, 2026
Last update
Oct 29, 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.
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904312
Lead sponsor
Ahmad badrah
Responsible party
Ahmad badrah (principal investigator, Ain Shams University) — Sponsor-investigator
First posted
Oct 29, 2026
Start date
Aug 29, 2025
Primary completion
Feb 10, 2026
Completion
May 11, 2026
Last update
Oct 29, 2026

Oversight

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

Not currently enrolling

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

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