Symptomatic Irreversible Pulpitis (SIP)PIRRINCT07191990
Measure Postoperative Pain and Bacterial Reduction After Different Final Irrigation Protocols.
A study testing Final irrigation by cryotreated NaOcl., Final irrigation by preheated NaOcl and Final irrigation with ultrasonic activation of NaOcl in people with Symptomatic Irreversible Pulpitis (SIP), run by Future University in Egypt at 1 site in Egypt.
Trial summary
The primary objective of root canal treatment is to clean, disinfect, and hermetically seal the root canal system to prevent bacterial penetration; however, postoperative pain is frequently encountered, particularly in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP)
- What is being tested?
- Final irrigation by cryotreated NaOcl., Final irrigation by preheated NaOcl and Final irrigation with ultrasonic activation of NaOcl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 with age range between 18 to 40.
- No sex predilection.
- Patients with symptomatic irreversible pulpitis.
- Patients able to sign informed consent.
- Restorable teeth
- Positive patient's acceptance for participating in the study.
- Type III distal and mesial canal of first mandibular molar.
- Mild to moderate (5-20) ° curvature according to Schneider
Who cannot join
- Pregnant females
- Medically compromised patients.
- Patients having analgesics before the treatment
- If antibiotic have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching
- Patients having sever malocclusion associated with traumatic occlusion.
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- Teeth that have:
- Peri-apical periodontitis Root resorption Pain on percussion Pulp stones or calcifications Previous endodontic treatment.
- -Non-patent canals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-operative Pain and Bacterial Load Reduction After Application of Different Final Irrigation Protocols in Single Visit Root Canal Treatment of Mandibular First Molar Teeth With Symptomatic Irreversible Pulpitis
The primary objective of root canal treatment is to clean, disinfect, and hermetically seal the root canal system to prevent bacterial penetration; however, postoperative pain is frequently encountered, particularly in patients with symptomatic irreversible pulpitis. This condition, defined by the American Association of Endodontists as an irreversible inflammatory state of the pulp, is commonly associated with spontaneous pain, lingering discomfort, and heightened thermal sensitivity, and often represents a significant challenge in endodontics. Postoperative pain is usually linked to extrusion of microorganisms and debris into the periapical region during chemo-mechanical preparation. Bacteria remain the most persistent pathogens in root canal infections, and although sodium hypochlorite (NaOCl) is considered the most effective irrigant due to its antibacterial and tissue-dissolving properties, complete bacterial elimination before root filling is not always achieved. To enhance its antimicrobial efficacy, various adjunctive approaches have been suggested, including passive ultrasonic activation (PUA) and modifying NaOCl temperature, either by heating or cooling. Cryotherapy has gained increasing attention in endodontics for its potential to decrease postoperative pain and bacterial load, with additional reported benefits in vital pulp therapy, instrumentation, and anesthesia. Previous studies have shown that cryo-irrigation after NaOCl significantly reduces bacterial counts compared to NaOCl alone. Considering the potential benefits of these different irrigation protocols, the present study aims to evaluate and compare their effectiveness in reducing postoperative pain and bacterial load following single-visit root canal treatment of mandibular first molars diagnosed with symptomatic irreversible pulpitis.
The aim of the study will be directed to evaluate postoperative pain and bacterial load reduction after application of different final irrigation protocols in single visit root canal treatment in patients with symptomatic irreversible pulpitis in first molar teeth. this study consists of 60 patients divided into 4 groups each group having 15 patients.
control: Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min interventions: I1: Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min . I2: Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min. I3:Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- Final irrigation by cryotreated NaOcl., Final irrigation by preheated NaOcl, Final irrigation with ultrasonic activation of NaOcl, Final irrigation by NaOcl at room temperature
- Keywords
- postoperative pain, bacterial load reduction
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Final irrigation by cryotreated NaOcl.Procedure or surgery
Also called cryotreated
Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min
Final irrigation by preheated NaOclProcedure or surgery
Also called preheated
Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min.
Final irrigation with ultrasonic activation of NaOclProcedure or surgery
Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min
Final irrigation by NaOcl at room temperatureProcedure or surgery
Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min
| Study group | Role | What they receive |
|---|---|---|
| Final irrigation by NaOcl at room temperature | Active comparator | Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min. Receives: Procedure: Final irrigation by NaOcl at room temperature |
| Final irrigation by cryotreated NaOcl. | Active comparator | Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min Receives: Procedure: Final irrigation by cryotreated NaOcl. |
| Final irrigation by preheated NaOcl. | Active comparator | Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min Receives: Procedure: Final irrigation by preheated NaOcl |
| Final irrigation with ultrasonic activation of NaOcl. | Active comparator | Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min Receives: Procedure: Final irrigation with ultrasonic activation of NaOcl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain after each activation method in comparison to control group
measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none (0): mild (1-3), severe (7-10).
Measured: from 6 to 72 hours from the treatment .
Secondary outcomes (1)
bacterial load change after final irrigation protocol.
Recording the percentage of bacterial load reduction by collecting samples by paper points, first sample after access cavity and before Root canal treatment.
second sample after mechanical instrumentation third sample after final irrigation
Measured: "immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Jul 2025
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Tarek, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191990
- Sponsor's protocol ID
- SamarRCT01
- Acronym
- PIRRI
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain and Bacterial Load Reduction After Application of Different Final Irrigation Protocols in Single Visit Root Canal Treatment of Mandibular First Molar Teeth With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07191990
- Acronym / sponsor ID
- PIRRI / SamarRCT01
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Keywords
- postoperative pain, bacterial load reduction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Sep 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.
The primary objective of root canal treatment is to clean, disinfect, and hermetically seal the root canal system to prevent bacterial penetration; however, postoperative pain is frequently encountered, particularly in patients with symptomatic irreversible pulpitis. This condition, defined by the American Association of Endodontists as an irreversible inflammatory state of the pulp, is commonly associated with spontaneous pain, lingering discomfort, and heightened thermal sensitivity, and often represents a significant challenge in endodontics. Postoperative pain is usually linked to extrusion of microorganisms and debris into the periapical region during chemo-mechanical preparation. Bacteria remain the most persistent pathogens in root canal infections, and although sodium hypochlorite (NaOCl) is considered the most effective irrigant due to its antibacterial and tissue-dissolving properties, complete bacterial elimination before root filling is not always achieved. To enhance its antimicrobial efficacy, various adjunctive approaches have been suggested, including passive ultrasonic activation (PUA) and modifying NaOCl temperature, either by heating or cooling. Cryotherapy has gained increasing attention in endodontics for its potential to decrease postoperative pain and bacterial load, with additional reported benefits in vital pulp therapy, instrumentation, and anesthesia. Previous studies have shown that cryo-irrigation after NaOCl significantly reduces bacterial counts compared to NaOCl alone. Considering the potential benefits of these different irrigation protocols, the present study aims to evaluate and compare their effectiveness in reducing postoperative pain and bacterial load following single-visit root canal treatment of mandibular first molars diagnosed with symptomatic irreversible pulpitis.
The aim of the study will be directed to evaluate postoperative pain and bacterial load reduction after application of different final irrigation protocols in single visit root canal treatment in patients with symptomatic irreversible pulpitis in first molar teeth. this study consists of 60 patients divided into 4 groups each group having 15 patients.
control: Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min interventions: I1: Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min . I2: Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min. I3:Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Final irrigation by NaOcl at room temperature | Active comparator | Procedure: Final irrigation by NaOcl at room temperatureFinal irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min. |
| Final irrigation by cryotreated NaOcl. | Active comparator | Procedure: Final irrigation by cryotreated NaOcl.Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min |
| Final irrigation by preheated NaOcl. | Active comparator | Procedure: Final irrigation by preheated NaOclFinal irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min |
| Final irrigation with ultrasonic activation of NaOcl. | Active comparator | Procedure: Final irrigation with ultrasonic activation of NaOclFinal irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with age range between 18 to 40.
- No sex predilection.
- Patients with symptomatic irreversible pulpitis.
- Patients able to sign informed consent.
- Restorable teeth
Key exclusion criteria (9 listed)
- Pregnant females
- Medically compromised patients.
- Patients having analgesics before the treatment
- If antibiotic have been administrated during the past two weeks preoperatively.
- Patients having bruxism or clenching
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 |
|---|---|---|
| Final irrigation by cryotreated NaOcl.Also: cryotreatedFinal irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min | Procedure or surgery | Final irrigation by cryotreated NaOcl. |
| Final irrigation by preheated NaOclAlso: preheatedFinal irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min. | Procedure or surgery | Final irrigation by preheated NaOcl. |
| Final irrigation with ultrasonic activation of NaOclFinal irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min | Procedure or surgery | Final irrigation with ultrasonic activation of NaOcl. |
| Final irrigation by NaOcl at room temperatureFinal irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min | Procedure or surgery | Final irrigation by NaOcl at room temperature |
Primary outcome
Post-operative pain after each activation method in comparison to control group
Time frame: from 6 to 72 hours from the treatment .
measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none (0): mild (1-3), severe (7-10).
1 secondary outcome
bacterial load change after final irrigation protocol.
Time frame: "immediately after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Final irrigation by cryotreated NaOcl., Final irrigation by preheated NaOcl and Final irrigation with ultrasonic activation of NaOcl in people with Symptomatic Irreversible Pulpitis (SIP), run by Future University in Egypt 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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-operative pain after each activation method in comparison to control group (time frame: from 6 to 72 hours from the treatment .). 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 25 Sep 2025.