Irreversible PulpitisNCT07904312
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
A study testing Extra-oral Cryotherapy, Intra-canal Cryotherapy and Combination (extra-oral and intra-canal) in people with Irreversible Pulpitis and Apical Periodontitis, run by Ahmad badrah at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Irreversible Pulpitis, Apical Periodontitis
- What is being tested?
- Extra-oral Cryotherapy, Intra-canal Cryotherapy and Combination (extra-oral and intra-canal)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2025to 11 May 2026
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Candidates received a comprehensive explanation of the study, provided written informed consent, 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Irreversible Pulpitis, Apical Periodontitis
- Being tested
- Extra-oral Cryotherapy, Intra-canal Cryotherapy, Combination (extra-oral and intra-canal), Conventional Endodontic Treatment
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-oral CryotherapyProcedure or surgery
Application of extra-oral cold packs (on the cheek) for 30 minutes after the conventional root canal treatment
Intra-canal CryotherapyProcedure or surgery
Application of intra-canal cold (2-4°C) 2.5% NaOCl irrigation after the conventional root canal treatment
Combination (extra-oral and intra-canal)Procedure or surgery
Received both extra-oral gel pack and intra-canal cold NaOCl applications (as previous) after the conventional root canal treatment
Conventional Endodontic TreatmentProcedure or surgery
Standard root canal treatment without the application of cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group I: Extra-oral Cryotherapy Group | Experimental | Patients will receive conventional root canal treatment accompanied by extra-oral cryotherapy application Receives: Procedure: Extra-oral Cryotherapy |
| Group II: Intra-canal Cryotherapy group | Experimental | Patients will receive conventional root canal treatment accompanied by intra-canal cryotherapy application Receives: Procedure: Intra-canal Cryotherapy |
| Group III: Combination Cryotherapy group | Experimental | Patients will receive conventional root canal treatment accompanied by both intra-canal and extra-oral cryotherapy application Receives: Procedure: Combination (extra-oral and intra-canal) |
| Group IV: Control Group | Active comparator | Conventional endodontic treatment without cryotherapy Receives: Procedure: Conventional Endodontic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Assessment of postoperative pain intensity using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at specific intervals
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start29 Aug 2025
- Primary completion10 Feb 2026
- Study completion11 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad badrah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad badrah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904312
- Sponsor's protocol ID
- FDASU-Rec IM012565
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07904312
- Acronym / sponsor ID
- FDASU-Rec IM012565
- Conditions
- Irreversible Pulpitis, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ahmad badrahUniversity, hospital or other
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 11 May 2026 (actual)
- First posted
- 29 Oct 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Extra-oral Cryotherapy Group | Experimental | Procedure: Extra-oral CryotherapyPatients will receive conventional root canal treatment accompanied by extra-oral cryotherapy application |
| Group II: Intra-canal Cryotherapy group | Experimental | Procedure: Intra-canal CryotherapyPatients will receive conventional root canal treatment accompanied by intra-canal cryotherapy application |
| Group III: Combination Cryotherapy group | Experimental | Procedure: Combination (extra-oral and intra-canal)Patients will receive conventional root canal treatment accompanied by both intra-canal and extra-oral cryotherapy application |
| Group IV: Control Group | Active comparator | Procedure: Conventional Endodontic TreatmentConventional endodontic treatment without cryotherapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Candidates received a comprehensive explanation of the study, provided written informed consent, 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.
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Extra-oral CryotherapyApplication of extra-oral cold packs (on the cheek) for 30 minutes after the conventional root canal treatment | Procedure or surgery | Group I: Extra-oral Cryotherapy Group |
| Intra-canal CryotherapyApplication of intra-canal cold (2-4°C) 2.5% NaOCl irrigation after the conventional root canal treatment | Procedure or surgery | Group II: Intra-canal Cryotherapy group |
| Combination (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 | Procedure or surgery | Group III: Combination Cryotherapy group |
| Conventional Endodontic TreatmentStandard root canal treatment without the application of cryotherapy | Procedure or surgery | Group IV: Control Group |
Primary outcome
Postoperative Pain
Time frame: Measured at 6, 12, 24, and 48 hours and 1 week postoperatively
Assessment of postoperative pain intensity using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at specific intervals
1 secondary outcome
substance P (SP) Levels
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
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 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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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 study testing Extra-oral Cryotherapy, Intra-canal Cryotherapy and Combination (extra-oral and intra-canal) in people with Irreversible Pulpitis and Apical Periodontitis, run by Ahmad badrah 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 4 inclusion and 15 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 29 Oct 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.
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: Measured at 6, 12, 24, and 48 hours and 1 week postoperatively). 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 29 Oct 2026.