Post Operative PainNCT07138365
Clinical and Biochemical Effects Of Cryotherapy Protocols On Mandibular Premolars With Symptomatic Apical Periodontitis
A study testing oral Cryotherapy, Intra radicular Cryotherapy and cold irrigation in people with Post Operative Pain and Inflammation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pain is the major reason for patients' visits to dental clinics.Medications have side effects. Treatments including cryotherapy have been suggested to prevent these side effects.This study will compare the effect of oral and intraradicular cryotherapy on the level of substance p ,post operative pain and analgesic… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Inflammation
- What is being tested?
- oral Cryotherapy, Intra radicular Cryotherapy and cold irrigation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders
- Eligible participants will be between the ages of 18-45
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study
- Having a mandibular single rooted premolar tooth with vital pulp Vertucci Type I canal system.
- Patients that will be diagnosed with symptomatic apical periodontitis on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale [VAS] > 7) and severe percussion pain (VAS > 7)
- The absence of periapical radiolucency on x ray.
Who cannot join
- Presence of any systemic disease or allergic reactions
- Vulnerable population: prisoners, pregnant women, mentally ill people, etc.
- Use of analgesic or antibiotic medication within seven days
- A radiographically untraceable canal
- Excessively curved root
- Excessively long or short root length
Show all 15Show fewer
- Teeth with open apices
- A previous root canal treatment
- Sinus tracts
- Local gum swelling around the affected tooth
- Severe periodontal disease
- Presence of periodontal pockets >3 mm in the affected tooth
- Absence of bleeding in the pulp chamber on access cavity preparation
- Problems in determining working length
- Broken files, over instrumentation, and overfilling/incomplete filling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Biochemical Effects Of Different Cryotherapy Protocols On Endodontic Treated Mandibular Premolars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
Pain is the major reason for patients' visits to dental clinics.Medications have side effects. Treatments including cryotherapy have been suggested to prevent these side effects.This study will compare the effect of oral and intraradicular cryotherapy on the level of substance p ,post operative pain and analgesic intake in mandibular premolars with symptomatic apical periodontitis.
Thirty patients with symptomatic apical periodontitis will be randomly distributed into three groups: oral,intraradicular cryotherapy and control group (n = 10). In the oral cryotherapy group application of (a cold pack of ice gel enveloped by a sealed plastic cover) will be performed for 30 minutes following the completion of canal preparation.Getting glide path by inserting K-file #10. coronal flaring will be done .The first apical fluid samples for all groups will be obtained at this step. Intra-radicular cryotherapy will be performed where normal root canal treatment will be done. Then a final flush will be done with 20 mL of cold saline 2.5°C for 10 minutes.
For the control group,no application of cryotherapy will be done.Second samples will be taken after mechanical preparation for intraradicular and control ,and after 30minutes of cold application for the cryotherapy group.Levels of substance p will be measured using the ELISA test.The patients will be asked to fill out the VAS questionnaire at 6, 24, 48 and 72 h.and analgesic intake
Read the detailed description
-Oral Cryo Group: All patients will receive anesthesia containing Artinibsa 4%:100,000 epinephrine (Inibsa, Spain) 1.8 mL .
The teeth will be isolated with a rubber dam (Sanctuary) after local anesthesia. Dental caries or restoration of the teeth, if any, will be removed .Access cavity will be done by new tapered stone with round end with copious coolant. Upon pulp exposure, dark profuse bleeding filled the pulp chamber. Initial glide path will be done by inserting K-file #10. After confirming glide path, coronal flaring will be done by orifice opener rotary file (M-Pro 19 taper 8). Working length will be determined by apex locator E PEX (Eighteeth Medical Technology Co., Ltd., Changzhou, China).The working length will be established at 0.5 mm short of the full length as determined by the electronic apex locatorand validated by a periapical radiograph.
First base line apical fluid sample (S1) will be collected at this step. Sterile paper point size 20 taper 2% will be inserted into the canal and placed 2 mm beyond the apex. The paper point will be left for 30 seconds to absorb sufficient amount of fluid. Paper point will be placed into an Eppendorf tube with 1 mL (pH 7.4) phosphate buffered saline and refrigerated at 10°C for later examination.
Mechanical preparation of the canals will be carried out according to the sequence of M pro rotary files kit #20/4, #25/6, #35/4, #40/4. Patency will be checked after each file with #10 k- file. Apical preparation will be further enlarged to manual file #50 or #55 in some cases. During the procedure, irrigation will be performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This will be done with 5 mL of 2.5% sodium hypochlorite (NaOCl). Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min.Final flush will be done with room temperature Saline for 10 minutes.
Next, custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.
Patients will be instructed to remove the ice pack for 2 minute if they felt extreme cold or a burning sensation. Each pack will be placed for 10 min, totaling three minimally per 30 min of intermittent application with 2-min breaks in between.
During the cryotherapy treatment, a thermocouple device will be used to monitor the temperature, which Will be maintained at 10 °C. If the temperature exceeded the predetermined threshold of 10 °C, immediate replacement of the gel pack with a new one will be carried out to bring the temperature back within the desired range.
After the completion of three cycles, the second sample of AF (S2) will be collected, as described earlier.
-Intra-Radicular Cryo Group: Access cavity was done by new tapered stone with round end with copious coolant. Upon pulp exposure, dark profuse bleeding filled the pulp chamber. Caries and old restoration were removed.
Initial glide path was done by inserting K-file #10. After confirming glide path, coronal flaring was done by orifice opener rotary file (M-Pro 19 taper 8). Working length was determined by apex locator.
First base line apical fluid sample (S1) was collected at this step. Sterile paper point size 20 taper 2% was inserted into the canal and placed 2 mm beyond the apex. The paper point was left for 30 seconds to absorb sufficient amount of fluid.
Mechanical preparation of the canals was carried out according to the sequence of M pro rotary files kit #20/4, #25/6, #35/4, #40/4. Patency was checked after each file with #10 k- file. Apical preparation was further enlarged to manual file #50 or #55 in some cases.
During the procedure, irrigation was performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This was done with 5 mL of 2.5% sodium hypochlorite (NaOCl), Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min. Final flush was done with cold (2-4 oC) Saline for 10 mins. Temperature of cold saline was maintained by keeping the irrigation syringes in an ice box filled with cooling gel packs with thermocouple inside to confirm that the temperature within range (2-4 oC). Irrigation syringes were used one by one.
The second sample (S2) was taken after chemo-mechanical preparation and finishing the irrigation protocol.
Cold Irrigation Group :
Canals were irrigated with cold (2-4 oC) 2.5% NaOCl. Final flush was done with cold (2-4 oC) Saline for 10 mins. First apical fluid sample will be taken after coronal flaring and determining the working length and the second one was taken after chemo-mechanical preparation and finishing the irrigation protocol.
-Control Group: Patients will receive conventional root canal treatment. Canals will be irrigated with room temperature 2.5% NaOCl. Final flush will be done with room temperature saline for 10 min.First apical fluid sample will be taken after coronal flaring and determining the working length and the second one was taken after chemo-mechanical preparation and finishing the irrigation protocol.
- Conditions
- Post Operative Pain, Inflammation
- Being tested
- oral Cryotherapy, Intra radicular Cryotherapy, cold irrigation
- Keywords
- Cryotherapy, post operative pain, inflammation, analgesic intake
- Medical subject headings
- Pain, Postoperative, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral CryotherapyProcedure or surgery
custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.
Intra radicular CryotherapyProcedure or surgery
Final flush was done with cold (2-4 oC) Saline for 10 mins.
cold irrigationProcedure or surgery
irrigation with cold (2-4 oC) 2.5% NaOCl and Final flush was done with cold (2-4 oC) Saline for 10 mins.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | No application of cryotherapy .Patients will receive conventional root canal treatment. Canals will be irrigated with room temperature 2.5% NaOCl. Final flush will be done with room temperature saline for 10 min. |
| Oral Cryo Group | Active comparator | custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.
Patients will be instructed to remove the ice pack for 2 minute if they felt extreme cold or a burning sensation. Each pack will be placed for 10 min, totaling three minimally per 30 min of intermittent application with 2-min breaks in between.
During the cryotherapy treatment, a thermocouple device will be used to monitor the temperature, which Will be maintained at 10 °C. If the temperature exceeded the predetermined threshold of 10 °C, immediate replacement of the gel pack with a new one will be carried out to bring the temperature back within the desired range. Receives: Procedure: oral Cryotherapy |
| Intra-Radicular Cryo Group | Active comparator | During the procedure, irrigation was performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This was done with 5 mL of 2.5% sodium hypochlorite (NaOCl), Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min. Final flush was done with cold (2-4 oC) Saline for 10 mins. Receives: Procedure: Intra radicular Cryotherapy |
| Cold Irr. group | Active comparator | Canals were irrigated with cold (2-4 oC) 2.5% NaOCl. Final flush was done with cold (2-4 oC) Saline for 10 mins. Receives: Procedure: cold irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of inflammatory mediator (substance P) in apical fluid
Sterile paper point size 20 taper 2% will be inserted into the canal and placed 2 mm beyond the apex. The paper point will be left for 30 seconds to absorb sufficient amount of fluid. Paper point will be placed into an Eppendorf tube with 1 mL (pH 7.4) phosphate buffered saline and refrigerated at 10°C for later examination.After collecting samples from all patients, the samples will be evaluated by the enzyme-linked immunosorbent assay (ELISA) method.
Measured: base line 1st sample:after glide path and coronal flaring for all groups second sample:in control group and intraradicular group taken after mechanical preparation, ,and in oral cryo group after mechanical application and 30 minutes application of cryo
Secondary outcomes (2)
level of post operative pain using 10 cm visual analoge scale (VAS)
On a10-cm Visual Analogue Scale (VAS) questionnaire, each patient reported their level of pain as follows: There is no pain at 0, 1-3, mild, 4-6, moderate, 7-9, severe, and 10, the worst pain
Measured: after 6hours, 24hours, 48hours, 72hours h after treatment
Analgesic intake
They will be asked if they needed to take the analgesics and the frequency of taking it.
Measured: They will be contacted by telephone at 6, 12, 24, 48 and 72 hours after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Model description
- randomized, controlled, single-blinded, single- center clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maram F Obeid, Professor, Study director, Faculty of Dentistry,Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138365
- Sponsor's protocol ID
- 943
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Detailed study protocol
Publications
Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.
PubMed 38233887Sharaf 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 40533695Hamza EM, Abd El Aziz TM, Obeid MF. The influence of intraoral cryotherapy on postoperative pain and substance P in symptomatic apical periodontitis: randomized clinical study. Sci Rep. 2024 Jun 17;14(1):13890. doi: 10.1038/s41598-024-64071-y.
PubMed 38880787Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
PubMed 29079057Obeid MF, Sharaf RMA, Hamza IMI. Clinical and biochemical effects of cryotherapy protocols on mandibular premolars with symptomatic apical periodontitis: a randomized clinical trial. Clin Oral Investig. 2026 Aug 22;30(9):405. doi: 10.1007/s00784-026-07073-6.
PubMed 42631770
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Effects Of Different Cryotherapy Protocols On Endodontic Treated Mandibular Premolars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07138365
- Acronym / sponsor ID
- 943
- Conditions
- Post Operative Pain, Inflammation
- Keywords
- Cryotherapy, post operative pain, inflammation, analgesic intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Aug 2025 (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.
Pain is the major reason for patients' visits to dental clinics.Medications have side effects. Treatments including cryotherapy have been suggested to prevent these side effects.This study will compare the effect of oral and intraradicular cryotherapy on the level of substance p ,post operative pain and analgesic intake in mandibular premolars with symptomatic apical periodontitis.
Thirty patients with symptomatic apical periodontitis will be randomly distributed into three groups: oral,intraradicular cryotherapy and control group (n = 10). In the oral cryotherapy group application of (a cold pack of ice gel enveloped by a sealed plastic cover) will be performed for 30 minutes following the completion of canal preparation.Getting glide path by inserting K-file #10. coronal flaring will be done .The first apical fluid samples for all groups will be obtained at this step. Intra-radicular cryotherapy will be performed where normal root canal treatment will be done. Then a final flush will be done with 20 mL of cold saline 2.5°C for 10 minutes.
For the control group,no application of cryotherapy will be done.Second samples will be taken after mechanical preparation for intraradicular and control ,and after 30minutes of cold application for the cryotherapy group.Levels of substance p will be measured using the ELISA test.The patients will be asked to fill out the VAS questionnaire at 6, 24, 48 and 72 h.and analgesic intake
Detailed description
-Oral Cryo Group: All patients will receive anesthesia containing Artinibsa 4%:100,000 epinephrine (Inibsa, Spain) 1.8 mL .
The teeth will be isolated with a rubber dam (Sanctuary) after local anesthesia. Dental caries or restoration of the teeth, if any, will be removed .Access cavity will be done by new tapered stone with round end with copious coolant. Upon pulp exposure, dark profuse bleeding filled the pulp chamber. Initial glide path will be done by inserting K-file #10. After confirming glide path, coronal flaring will be done by orifice opener rotary file (M-Pro 19 taper 8). Working length will be determined by apex locator E PEX (Eighteeth Medical Technology Co., Ltd., Changzhou, China).The working length will be established at 0.5 mm short of the full length as determined by the electronic apex locatorand validated by a periapical radiograph.
First base line apical fluid sample (S1) will be collected at this step. Sterile paper point size 20 taper 2% will be inserted into the canal and placed 2 mm beyond the apex. The paper point will be left for 30 seconds to absorb sufficient amount of fluid. Paper point will be placed into an Eppendorf tube with 1 mL (pH 7.4) phosphate buffered saline and refrigerated at 10°C for later examination.
Mechanical preparation of the canals will be carried out according to the sequence of M pro rotary files kit #20/4, #25/6, #35/4, #40/4. Patency will be checked after each file with #10 k- file. Apical preparation will be further enlarged to manual file #50 or #55 in some cases. During the procedure, irrigation will be performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This will be done with 5 mL of 2.5% sodium hypochlorite (NaOCl). Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min.Final flush will be done with room temperature Saline for 10 minutes.
Next, custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.
Patients will be instructed to remove the ice pack for 2 minute if they felt extreme cold or a burning sensation. Each pack will be placed for 10 min, totaling three minimally per 30 min of intermittent application with 2-min breaks in between.
During the cryotherapy treatment, a thermocouple device will be used to monitor the temperature, which Will be maintained at 10 °C. If the temperature exceeded the predetermined threshold of 10 °C, immediate replacement of the gel pack with a new one will be carried out to bring the temperature back within the desired range.
After the completion of three cycles, the second sample of AF (S2) will be collected, as described earlier.
-Intra-Radicular Cryo Group: Access cavity was done by new tapered stone with round end with copious coolant. Upon pulp exposure, dark profuse bleeding filled the pulp chamber. Caries and old restoration were removed.
Initial glide path was done by inserting K-file #10. After confirming glide path, coronal flaring was done by orifice opener rotary file (M-Pro 19 taper 8). Working length was determined by apex locator.
First base line apical fluid sample (S1) was collected at this step. Sterile paper point size 20 taper 2% was inserted into the canal and placed 2 mm beyond the apex. The paper point was left for 30 seconds to absorb sufficient amount of fluid.
Mechanical preparation of the canals was carried out according to the sequence of M pro rotary files kit #20/4, #25/6, #35/4, #40/4. Patency was checked after each file with #10 k- file. Apical preparation was further enlarged to manual file #50 or #55 in some cases.
During the procedure, irrigation was performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This was done with 5 mL of 2.5% sodium hypochlorite (NaOCl), Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min. Final flush was done with cold (2-4 oC) Saline for 10 mins. Temperature of cold saline was maintained by keeping the irrigation syringes in an ice box filled with cooling gel packs with thermocouple inside to confirm that the temperature within range (2-4 oC). Irrigation syringes were used one by one.
The second sample (S2) was taken after chemo-mechanical preparation and finishing the irrigation protocol.
Cold Irrigation Group :
Canals were irrigated with cold (2-4 oC) 2.5% NaOCl. Final flush was done with cold (2-4 oC) Saline for 10 mins. First apical fluid sample will be taken after coronal flaring and determining the working length and the second one was taken after chemo-mechanical preparation and finishing the irrigation protocol.
-Control Group: Patients will receive conventional root canal treatment. Canals will be irrigated with room temperature 2.5% NaOCl. Final flush will be done with room temperature saline for 10 min.First apical fluid sample will be taken after coronal flaring and determining the working length and the second one was taken after chemo-mechanical preparation and finishing the irrigation protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized, controlled, single-blinded, single- center clinical trial
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –No application of cryotherapy .Patients will receive conventional root canal treatment. Canals will be irrigated with room temperature 2.5% NaOCl. Final flush will be done with room temperature saline for 10 min. |
| Oral Cryo Group | Active comparator | Procedure: oral Cryotherapycustom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth. Patients will be instructed to remove the ice pack for 2 minute if they felt extreme cold or a burning sensation. Each pack will be placed for 10 min, totaling three minimally per 30 min of intermittent application with 2-min breaks in between. During the cryotherapy treatment, a thermocouple device will be used to monitor the temperature, which Will be maintained at 10 °C. If the temperature exceeded the predetermined threshold of 10 °C, immediate replacement of the gel pack with a new one will be carried out to bring the temperature back within the desired range. |
| Intra-Radicular Cryo Group | Active comparator | Procedure: Intra radicular CryotherapyDuring the procedure, irrigation was performed between each rotary file using a side-vented needle (gauge size 30) positioned 2mm from the working length. This was done with 5 mL of 2.5% sodium hypochlorite (NaOCl), Followed by 5 ml of 17% EDTA (META BIOMED, Korea) for 1 min. Final flush was done with cold (2-4 oC) Saline for 10 mins. |
| Cold Irr. group | Active comparator | Procedure: cold irrigationCanals were irrigated with cold (2-4 oC) 2.5% NaOCl. Final flush was done with cold (2-4 oC) Saline for 10 mins. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both genders
- Eligible participants will be between the ages of 18-45
- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study
- Having a mandibular single rooted premolar tooth with vital pulp Vertucci Type I canal system.
- Patients that will be diagnosed with symptomatic apical periodontitis on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale [VAS] > 7) and severe percussion pain (VAS > 7)
Key exclusion criteria (15 listed)
- Presence of any systemic disease or allergic reactions
- Vulnerable population: prisoners, pregnant women, mentally ill people, etc.
- Use of analgesic or antibiotic medication within seven days
- A radiographically untraceable canal
- Excessively curved root
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 |
|---|---|---|
| oral Cryotherapycustom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth. | Procedure or surgery | Oral Cryo Group |
| Intra radicular CryotherapyFinal flush was done with cold (2-4 oC) Saline for 10 mins. | Procedure or surgery | Intra-Radicular Cryo Group |
| cold irrigationirrigation with cold (2-4 oC) 2.5% NaOCl and Final flush was done with cold (2-4 oC) Saline for 10 mins. | Procedure or surgery | Cold Irr. group |
Primary outcome
Level of inflammatory mediator (substance P) in apical fluid
Time frame: base line 1st sample:after glide path and coronal flaring for all groups second sample:in control group and intraradicular group taken after mechanical preparation, ,and in oral cryo group after mechanical application and 30 minutes application of cryo
Sterile paper point size 20 taper 2% will be inserted into the canal and placed 2 mm beyond the apex. The paper point will be left for 30 seconds to absorb sufficient amount of fluid. Paper point will be placed into an Eppendorf tube with 1 mL (pH 7.4) phosphate buffered saline and refrigerated at 10°C for later examination.After collecting samples from all patients, the samples will be evaluated by the enzyme-linked immunosorbent assay (ELISA) method.
2 secondary outcomes
level of post operative pain using 10 cm visual analoge scale (VAS)
Time frame: after 6hours, 24hours, 48hours, 72hours h after treatment
Analgesic intake
Time frame: They will be contacted by telephone at 6, 12, 24, 48 and 72 hours after
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 11 Feb 2026.
- Background: PubMed 38233887Abdel-Baset ST, Fahmy SH, Obeid MF. Can instrumentation kinematics affect postoperative pain and substance P levels? A randomized controlled trial. BMC Oral Health. 2024 Jan 17;24(1):102. doi: 10.1186/s12903-024-03882-x.
- Background: 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.
- Background: PubMed 38880787Hamza EM, Abd El Aziz TM, Obeid MF. The influence of intraoral cryotherapy on postoperative pain and substance P in symptomatic apical periodontitis: randomized clinical study. Sci Rep. 2024 Jun 17;14(1):13890. doi: 10.1038/s41598-024-64071-y.
- Background: PubMed 29079057Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
- Derived from this study: PubMed 42631770Obeid MF, Sharaf RMA, Hamza IMI. Clinical and biochemical effects of cryotherapy protocols on mandibular premolars with symptomatic apical periodontitis: a randomized clinical trial. Clin Oral Investig. 2026 Aug 22;30(9):405. doi: 10.1007/s00784-026-07073-6.
- Individual participant dataSharing planned: Yes. Detailed study protocol
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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 oral Cryotherapy, Intra radicular Cryotherapy and cold irrigation 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 6 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 11 Feb 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?
Level of inflammatory mediator (substance P) in apical fluid (time frame: base line 1st sample:after glide path and coronal flaring for all groups second sample:in control group and intraradicular group taken after mechanical preparation, ,and in oral cryo group after mechanical application and 30 minutes application of cryo). 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 NCT07138365, which also lists 5 linked publications.
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 11 Feb 2026.