Post Operative PainNCT06106386
The Effect of Different Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P
A study testing cryotherapy in people with Post Operative Pain and Inflammation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite The main questions to answer are: 1. Does Postoperative pain is different between the three groups? 2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Inflammation
- What is being tested?
- cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Mar 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients that will be diagnosed with symptomatic apical periodontitis
- Single-rooted premolars (radiographically and clinically assessed)
- Medically free patients.
- Teeth with mature apex
Who cannot join
- Patients with other pulpal diagnosis.
- Medically compromised patients.
- Pregnant females.
- Patients taking analgesics or anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Using Cold Irrigation on Postoperative Endodontic Pain and Substance P Level: a Randomized Clinical Trial
The aim of this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite
The main questions to answer are:
- Does Postoperative pain is different between the three groups?
- Does level of substance P different between the three groups ?
Read the detailed description
- The patients will be randomly divided into three groups Group 1: control group (n=25) Regular root canal treatment with regular irrigant will be used. Group 2: (n=25) Intraradicular cryotherapy will be performed where :
- Normal root canal treatment will be done with irrigation using sodium hypochlorite cooled to 2°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes. Group 3: (n=25) Normal root canal treatment will be done with irrigation using sodium hypochlorite at room temperature during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes.
- Conditions
- Post Operative Pain, Inflammation
- Being tested
- cryotherapy
- Keywords
- Cryotherapy, Substance P, Apical periodontitis, Post Operative Pain
- Medical subject headings
- Pain, Postoperative, Inflammation, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyOther
Cooling of irrigation
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite |
| Cryotherapy Group | Experimental | Root canal treatment is done and irrigation is done with cooled sodium hypochlorite ( 2- 4°C) through out the visits and final flush with 2- 4°C cold saline will be used for 5 minutes. Receives: Other: cryotherapy |
| Final Flush group | Active comparator | Root canal treatment is done and irrigation is done with sodium hypochlorite at room temperature through out the visits then final flush with 2- 4°C cold saline will be used for 5 minutes. Receives: Other: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of post operative pain
On visual analogue scale (VAS) questionnaire, patients will report their level of pain 0° refers for no pain, and the 100° degree refers for unbearable pain
Measured: after 6 hours, 24 hours, 48 hours, 72 hours
Secondary outcomes (1)
Level of substance P
apical fluid sample will be taken using sterilized, medium sized paper point (Diadent Korea, Seoul, Korea) will be inserted into the periapical area and left in place for 30 seconds and the sample will be placed into a 1.5-mL Eppendorf tube containing 100 _L of Tris-HCl buffer, pH 7.5, with 0.15 M NaCl and 1 mM CaCl2; the tubes will be placed on a shaker at room temperature for 3 hours and then stored at -70°C
Measured: After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2024
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Obeid, Ain Shams University
- Investigators
- Maram F Obeid, Professor, Study director, Faculty of dentistry Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106386
- Sponsor's protocol ID
- 20720
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sharaf RMA, Abdelrahman TY, Obeid MF. The impact of using cold irrigation on postoperative endodontic pain and substance P level: a randomized clinical trial. Odontology. 2026 Apr;114(2):527-536. doi: 10.1007/s10266-025-01131-3. Epub 2025 Jun 18.
PubMed 40533695
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Cold Irrigation on Postoperative Endodontic Pain and Substance P Level: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06106386
- Acronym / sponsor ID
- 20720
- Conditions
- Post Operative Pain, Inflammation
- Keywords
- Cryotherapy, Substance P, Apical periodontitis, Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 30 Oct 2023 (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 this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite
The main questions to answer are:
- Does Postoperative pain is different between the three groups?
- Does level of substance P different between the three groups ?
Detailed description
- The patients will be randomly divided into three groups Group 1: control group (n=25) Regular root canal treatment with regular irrigant will be used. Group 2: (n=25) Intraradicular cryotherapy will be performed where :
- Normal root canal treatment will be done with irrigation using sodium hypochlorite cooled to 2°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes. Group 3: (n=25) Normal root canal treatment will be done with irrigation using sodium hypochlorite at room temperature during our mechanical instrumentation. Then a final flush will be done with cold saline 2°C for 5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite |
| Cryotherapy Group | Experimental | Other: cryotherapyRoot canal treatment is done and irrigation is done with cooled sodium hypochlorite ( 2- 4°C) through out the visits and final flush with 2- 4°C cold saline will be used for 5 minutes. |
| Final Flush group | Active comparator | Other: cryotherapyRoot canal treatment is done and irrigation is done with sodium hypochlorite at room temperature through out the visits then final flush with 2- 4°C cold saline will be used for 5 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients that will be diagnosed with symptomatic apical periodontitis
- Single-rooted premolars (radiographically and clinically assessed)
- Medically free patients.
- Teeth with mature apex
Key exclusion criteria (4 listed)
- Patients with other pulpal diagnosis.
- Medically compromised patients.
- Pregnant females.
- Patients taking analgesics or anti-inflammatory drugs.
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 |
|---|---|---|
| cryotherapyCooling of irrigation | Other | Cryotherapy Group, Final Flush group |
Primary outcome
Level of post operative pain
Time frame: after 6 hours, 24 hours, 48 hours, 72 hours
On visual analogue scale (VAS) questionnaire, patients will report their level of pain 0° refers for no pain, and the 100° degree refers for unbearable pain
1 secondary outcome
Level of substance P
Time frame: After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)
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 13 Dec 2024.
- Derived from this study: PubMed 40533695Sharaf RMA, Abdelrahman TY, Obeid MF. The impact of using cold irrigation on postoperative endodontic pain and substance P level: a randomized clinical trial. Odontology. 2026 Apr;114(2):527-536. doi: 10.1007/s10266-025-01131-3. Epub 2025 Jun 18.
- 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.
Maram F Obeid, Professor study director
Faculty of dentistry Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with Post Operative Pain and Inflammation, run by Ain Shams 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 4 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: finished, as of the sponsor's last update on 13 Dec 2024. 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?
Level of post operative pain (time frame: after 6 hours, 24 hours, 48 hours, 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06106386, which also lists 1 linked publication.
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 13 Dec 2024.