Symptomatic Irreversible Pulpitis (SIP)NCT07627867
Effect of Intracanal Cryotherapy Versus Laser Application on Postoperative-pain and Bacterial Load Reduction in Single Visit Root Canal Treatment in Patients With Symptomatic Irreversible Pulpitis in Mandibular First Molar Teeth (Randomized Control Trial)
A study testing final irrigation by NaOcl at room temperature, final irrigation by Cryotreated NaOcl and final irrigation by preheated NaOcl in people with Symptomatic Irreversible Pulpitis (SIP), run by Future University in Egypt at 1 site in Egypt.
Trial summary
This randomized controlled clinical trial investigates the Effect of Intracanal Cryotherapy Versus Laser Application on Post-Operative Pain and Bacterial Load Reduction in Single-Visit Root Canal Treatment in Patients with Symptomatic Irreversible Pulpitis in Mandibular First Molars. 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 NaOcl at room temperature, final irrigation by Cryotreated NaOcl and final irrigation by preheated 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 Dec 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 aged 18 to 40 years.
- Patients able to understand and sign the informed consent form.
- Patients who positively accept to participate in the study.
- Patients diagnosed with symptomatic irreversible pulpitis in a restorable mandibular first molar.
- The affected tooth must have a mesial and distal root canal configuration classified as Type III according to Vertucci's classification.
- The root curvature of the involved canals must be mild to moderate (5-20°), as measured by Schneider's method.
- No sex predilection.
Who cannot join
- Patients who are pregnant or lactating.
- Medically compromised patients (e.g., with systemic conditions that contraindicate dental treatment or affect pain perception).
- Patients who have taken any analgesic medication within 8 hours prior to the appointed treatment.
- Patients who have taken antibiotics within the two weeks prior to the preoperative assessment.
- Patients with parafunctional habits such as bruxism or clenching.
- Patients with severe malocclusion associated with traumatic occlusion.
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- Teeth exhibiting any of the following:
- Pain on percussion.
- A diagnosis of peri-apical periodontitis or a peri-radicular lesion.
- Internal or external root resorption.
- Pulp stones or significant canal calcifications.
- Evidence of previous endodontic treatment.
- Teeth with non-patent canals or canals that cannot be negotiated.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled clinical trial investigates the Effect of Intracanal Cryotherapy Versus Laser Application on Post-Operative Pain and Bacterial Load Reduction in Single-Visit Root Canal Treatment in Patients with Symptomatic Irreversible Pulpitis in Mandibular First Molars. Sixty patients aged 18-40 years with restorable mandibular first molars diagnosed with symptomatic irreversible pulpitis will be enrolled at the Endodontic Department, Faculty of Oral and Dental Medicine, Future University in Egypt. Participants will be randomly allocated into four groups: Group 1 (control) will receive final irrigation with 2.6% sodium hypochlorite (NaOCl) at room temperature (24°C), Group 2 will receive cryotreated NaOCl (2-4°C), Group 3 will receive preheated NaOCl (60°C), and Group 4 will receive laser-activated NaOCl, each applied for one minute. The study will be double-blind for both the operator and the patient. Post-operative pain will be assessed using a Numerical Rating Scale (0-10) at 6, 12, 24, 48, and 72 hours post-treatment. Bacterial load reduction will be measured microbiologically at three stages: after access cavity preparation, after instrumentation, and after final irrigation. Statistical analysis will be performed using SPSS version 24 and Minitab version 16, with a significance level of p < 0.05. The study has received ethical approval from the Future University Ethics Committee and is conducted without external funding.
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- Being tested
- final irrigation by NaOcl at room temperature, final irrigation by Cryotreated NaOcl, final irrigation by preheated NaOcl, final irrigation by NaOCI activated by laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
final irrigation by NaOcl at room temperatureProcedure or surgery
final irrigation by NaOcl (2.6%) at room temperature 24°C for 1 min.
final irrigation by Cryotreated NaOclProcedure or surgery
final irrigation by Cryotreated NaOcl (2.6%) at 2-4°C for 1 min.
final irrigation by preheated NaOclProcedure or surgery
final irrigation by preheated NaOcl (2.6%) at 60°C for 1 min.
final irrigation by NaOCI activated by laserProcedure or surgery
final irrigation by NaOCI (2.6%) activated by laser for 1 min.
| Study group | Role | What they receive |
|---|---|---|
| Final irrigation by NaOCI at room temperature | Active comparator | final irrigated using NaOCI (2.6%) at room temperature 24°C for 1 min. Receives: Procedure: final irrigation by preheated NaOcl |
| Final Irrigation by Cryotreated NaOCI | Active comparator | final irrigated using NaOCI (2.6%) that Cryotreated at 2-4°C for 1 min. Receives: Procedure: final irrigation by NaOCI activated by laser |
| Final Irrigation by Preheated NaOCI | Active comparator | final irrigated using NaOCI (2.6%) Preheated at 60°C for 1 min. Receives: Procedure: final irrigation by Cryotreated NaOcl |
| Final Irrigation by Laser Activated NaOCI | Active comparator | finally irrigated using NaOCI (2.6%) activated by laser for 1 min. Receives: Procedure: final irrigation by NaOcl at room temperature |
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 posted4 Jun 2026
- Study start1 Jul 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 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, Albatool Rummani, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627867
- Sponsor's protocol ID
- ARummani
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intracanal Cryotherapy Versus Laser Application on Postoperative-pain and Bacterial Load Reduction in Single Visit Root Canal Treatment in Patients With Symptomatic Irreversible Pulpitis in Mandibular First Molar Teeth (Randomized Control Trial)
- ClinicalTrials.gov ID
- NCT07627867
- Acronym / sponsor ID
- ARummani
- Conditions
- Symptomatic Irreversible Pulpitis (SIP)
- 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
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 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 investigates the Effect of Intracanal Cryotherapy Versus Laser Application on Post-Operative Pain and Bacterial Load Reduction in Single-Visit Root Canal Treatment in Patients with Symptomatic Irreversible Pulpitis in Mandibular First Molars. Sixty patients aged 18-40 years with restorable mandibular first molars diagnosed with symptomatic irreversible pulpitis will be enrolled at the Endodontic Department, Faculty of Oral and Dental Medicine, Future University in Egypt. Participants will be randomly allocated into four groups: Group 1 (control) will receive final irrigation with 2.6% sodium hypochlorite (NaOCl) at room temperature (24°C), Group 2 will receive cryotreated NaOCl (2-4°C), Group 3 will receive preheated NaOCl (60°C), and Group 4 will receive laser-activated NaOCl, each applied for one minute. The study will be double-blind for both the operator and the patient. Post-operative pain will be assessed using a Numerical Rating Scale (0-10) at 6, 12, 24, 48, and 72 hours post-treatment. Bacterial load reduction will be measured microbiologically at three stages: after access cavity preparation, after instrumentation, and after final irrigation. Statistical analysis will be performed using SPSS version 24 and Minitab version 16, with a significance level of p < 0.05. The study has received ethical approval from the Future University Ethics Committee and is conducted without external funding.
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 NaOCI at room temperature | Active comparator | Procedure: final irrigation by preheated NaOclfinal irrigated using NaOCI (2.6%) at room temperature 24°C for 1 min. |
| Final Irrigation by Cryotreated NaOCI | Active comparator | Procedure: final irrigation by NaOCI activated by laserfinal irrigated using NaOCI (2.6%) that Cryotreated at 2-4°C for 1 min. |
| Final Irrigation by Preheated NaOCI | Active comparator | Procedure: final irrigation by Cryotreated NaOclfinal irrigated using NaOCI (2.6%) Preheated at 60°C for 1 min. |
| Final Irrigation by Laser Activated NaOCI | Active comparator | Procedure: final irrigation by NaOcl at room temperaturefinally irrigated using NaOCI (2.6%) activated by laser for 1 min. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients aged 18 to 40 years.
- Patients able to understand and sign the informed consent form.
- Patients who positively accept to participate in the study.
- Patients diagnosed with symptomatic irreversible pulpitis in a restorable mandibular first molar.
- The affected tooth must have a mesial and distal root canal configuration classified as Type III according to Vertucci's classification.
Key exclusion criteria (13 listed)
- Patients who are pregnant or lactating.
- Medically compromised patients (e.g., with systemic conditions that contraindicate dental treatment or affect pain perception).
- Patients who have taken any analgesic medication within 8 hours prior to the appointed treatment.
- Patients who have taken antibiotics within the two weeks prior to the preoperative assessment.
- Patients with parafunctional habits such as 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 NaOcl at room temperaturefinal irrigation by NaOcl (2.6%) at room temperature 24°C for 1 min. | Procedure or surgery | Final Irrigation by Laser Activated NaOCI |
| final irrigation by Cryotreated NaOclfinal irrigation by Cryotreated NaOcl (2.6%) at 2-4°C for 1 min. | Procedure or surgery | Final Irrigation by Preheated NaOCI |
| final irrigation by preheated NaOclfinal irrigation by preheated NaOcl (2.6%) at 60°C for 1 min. | Procedure or surgery | Final irrigation by NaOCI at room temperature |
| final irrigation by NaOCI activated by laserfinal irrigation by NaOCI (2.6%) activated by laser for 1 min. | Procedure or surgery | Final Irrigation by Cryotreated NaOCI |
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 4 Jun 2026.
- 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 NaOcl at room temperature, final irrigation by Cryotreated NaOcl and final irrigation by preheated 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 7 inclusion and 13 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 4 Jun 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?
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 4 Jun 2026.