Necrotic TeethPhase 1/2NCT07420920
Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of NaOCL
A Phase 1/2 study testing System-B and Ultrasonic activation in people with Necrotic Teeth, run by Misr University for Science and Technology.
Trial summary
The goal of this clinical trial is to is to assess the antibacterial effect of sodium hypochlorite heated inside root canals of necrotic teeth using various activation techniques The main question it aims to answer is: Does the antibacterial effect vary following various standardized techniques of intracanal heating… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotic Teeth
- What is being tested?
- System-B and Ultrasonic activation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to Jun 2026
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For patients:
- adult male or female patients
- medically free.
- For selected teeth:
- asymptomatic necrotic single rooted teeth
- teeth with mature root
- restorable teeth.
Who cannot join
- For patients:
- Patients with dental related symptoms
- patients with chronic or systemic diseases
- pregnant females.
- For selected teeth:
- multirooted teeth
Show all 10Show fewer
- vital teeth
- teeth with incompletely formed roots
- teeth with internal or external resorption
- previously root canal treated teeth
About this study
Official title: Assessment of the Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of Sodium Hypochlorite: A Randomized Clinical Trial
The goal of this clinical trial is to is to assess the antibacterial effect of sodium hypochlorite heated inside root canals of necrotic teeth using various activation techniques
The main question it aims to answer is:
Does the antibacterial effect vary following various standardized techniques of intracanal heating of sodium hypochlorite in endodontic treatment?
Read the detailed description
Root canal treatment success depends on the removal of necrotic and vital pulp tissues and bacteria and bacterial byproducts from the root canal system.
Mechanical cleansing and removal of necrotic or vital pulp tissue lead to the formation of a layer of debris called " Smear layer," which is made of organic and inorganic substances that should be removed from the root canal system with the help of irrigants.
The presence of complex anatomy like isthmi and anastomoses makes chemical cleansing of the root canal system difficult because they are filled with the smear layer.
The ideal features of root canal irrigants include cleansing, lubrication of endodontic instruments and root canal system, dissolution of inorganic and organic tissues, antimicrobial properties, absence of cytotoxicity without alteration of dental microstructure. Sodium hypochlorite (NaOCl) has been the most widely used irrigant in endodontics due to its antimicrobial and tissue-dissolving action.
Due to the presence of complex anatomy inside the root canal system, activation of irrigation is essential to improve the cleaning of such a complex system. Ultrasonic activation is presently the most popular method for activation of irrigation. It delivers the irrigant farther into areas of the root canal system untouched by instruments, and it improves the mechanical cleaning by increasing the wall shear stress.
NaOCl is used in concentrations between 0.5% - 6%. In high concentrations, it may have a faster dissolution capacity, but it is associated with toxicity in cases of extrusion; thus, methods to improve the action of less concentrated solutions become relevant, such as agitation of the irrigant, constant refreshment and volume, and heating of the solution. Using NaOCl solution at high temperature is related to an increase in reactivity and, therefore, a reduction in bacterial counts and bacterial biofilm dissolution. Although the dentin acts as a thermal insulator, the excessive increase in temperature could dissipate to the periapical tissues, causing damage to the bone tissue .
Initially, it was suggested to heat NaOCl before inserting it into the canals, but this was of little effectiveness .
Woodmansey demonstrated that NaOCl solution can dissolve pulp tissue 210 times faster at boiling temperature (90-120°C) than at room temperature. However, this method remained limited due to the lack of studies confirming its safety until Simeone et al. confirmed that when NaOCl solution is heated inside the canals at a temperature of 150°C for 10 seconds, the temperature of the periodontal tissues does not rise above 42.5°C, which is within the acceptable limits for the periodontal tissue.
Intracanal heating to 180°C using System-B Heat Source shows better antibacterial efficacy than preheated sodium hypochlorite at 60°C. Also, it has been suggested to use low-concentration NaOCl at elevated temperature to report the evidence for better antimicrobial and tissue dissolution properties.
A combination of these two activation methods by ultrasonic agitation of sodium hypochlorite, followed by intracanal heating, may have promising results with regard to the removal of bacteria.
Patients frequently encounter postoperative pain after root canal treatment, and one of the causes is that NaOCl at a higher concentration is irritant to surrounding tissue, particularly in the case of extrusion. Irrigation using lower concentration NaOCl was effective in reducing postoperative pain.
Based on the previous studies, studying the effect of irrigation using low concentration NaOCl (2.6%), which can be activated to increase its reactivity, could give predectible antibacterial effect while reducing postoperative pain and toxicity associated with extrusion.
- Conditions
- Necrotic Teeth
- Being tested
- System-B, Ultrasonic activation
- Keywords
- Necrotic teeth,, Endodontic irriggation, Irrigation activation, Intracanal heating, Sodium hypochlorite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
System-BDevice
The irrigation activation by heating is achieved using System-B heat carrier
Ultrasonic activationDevice
Activation of irrigation using ultrasonic
| Study group | Role | What they receive |
|---|---|---|
| Intracanal heating for activation using ultrasonics | Active comparator | Not described Receives: Device: Ultrasonic activation |
| Intracanal heating for activation using System-B heat carrier | Experimental | Not described Receives: Device: System-B |
| Intracanal heating for activation using a combination of ultrasonics and System-B | Experimental | Not described Receives: Device: System-B; Device: Ultrasonic activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial reduction
Antibacterial effect is evaluated by counting number of bacterial colonies, samples are collected and placed in brain-heart infusion (BHI) broth and subjected to microbiological analysis to determine the colony-forming unit (CFU)/ml
Measured: after treatment, samples are sent to microbiology lab and bacterial count is measured day 1 after treatment.
Secondary outcomes (1)
Post-operative pain
Postoperative pain is assessed for each patient using Visual Analog Scale (VAS) with a score ranging from 0 (no pain) to 10 (unbearable pain)
Measured: Post operative pain is measured until day 3 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completionJun 2026 (estimated)
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 Necrotic TeethStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa El din Yasser Mohamed Salah Eldin, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420920
- Sponsor's protocol ID
- 2024/0042
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Govindaraju L, Shruthi ST, Gopal R, Jenarthanan S, Rajendran MR. Does increase in temperature of sodium hypochlorite have enhanced antimicrobial efficacy and tissue dissolution property? - A systematic review and meta-regression. J Conserv Dent Endod. 2024 Jul;27(7):675-684. doi: 10.4103/JCDE.JCDE_110_24. Epub 2024 Jul 8.
PubMed 39262604Iandolo A, Amato M, Dagna A, Poggio C, Abdellatif D, Franco V, Pantaleo G. Intracanal heating of sodium hypochlorite: Scanning electron microscope evaluation of root canal walls. J Conserv Dent. 2018 Sep-Oct;21(5):569-573. doi: 10.4103/JCD.JCD_245_18.
PubMed 30294123Rathore, V., Samel, D., Moogi, P., Bandekar, S., Kshirsagar, S., Vyas, C., 2020. Antimicrobial efficacy of intracanal and extracanal heated sodium hypochlorite against Enterococcus faecalis: An in vitro study. Endodontology 32, 112-117. https://doi.org/10.4103/endo.endo_21_20
Yared G, Al Asmar Ramli G. Antibacterial Ability of Sodium Hypochlorite Heated in the Canals of Infected Teeth: An Ex Vivo Study. Cureus. 2020 Feb 13;12(2):e6975. doi: 10.7759/cureus.6975.
PubMed 32201655Simeone, M., Valletta, A., Giudice, A., Di Lorenzo, P., Iandolo, A., 2015. The activation of irrigation solutions in Endodontics: A perfected technique. G. Ital. Endod. 29, 65-69. https://doi.org/10.1016/j.gien.2015.08.005
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Antibacterial Effect and Post-operative Pain Following Various Techniques of Intracanal Heating of Sodium Hypochlorite: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07420920
- Acronym / sponsor ID
- 2024/0042
- Conditions
- Necrotic Teeth
- Keywords
- Necrotic teeth,, Endodontic irriggation, Irrigation activation, Intracanal heating, Sodium hypochlorite
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Feb 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.
The goal of this clinical trial is to is to assess the antibacterial effect of sodium hypochlorite heated inside root canals of necrotic teeth using various activation techniques
The main question it aims to answer is:
Does the antibacterial effect vary following various standardized techniques of intracanal heating of sodium hypochlorite in endodontic treatment?
Detailed description
Root canal treatment success depends on the removal of necrotic and vital pulp tissues and bacteria and bacterial byproducts from the root canal system.
Mechanical cleansing and removal of necrotic or vital pulp tissue lead to the formation of a layer of debris called " Smear layer," which is made of organic and inorganic substances that should be removed from the root canal system with the help of irrigants.
The presence of complex anatomy like isthmi and anastomoses makes chemical cleansing of the root canal system difficult because they are filled with the smear layer.
The ideal features of root canal irrigants include cleansing, lubrication of endodontic instruments and root canal system, dissolution of inorganic and organic tissues, antimicrobial properties, absence of cytotoxicity without alteration of dental microstructure. Sodium hypochlorite (NaOCl) has been the most widely used irrigant in endodontics due to its antimicrobial and tissue-dissolving action.
Due to the presence of complex anatomy inside the root canal system, activation of irrigation is essential to improve the cleaning of such a complex system. Ultrasonic activation is presently the most popular method for activation of irrigation. It delivers the irrigant farther into areas of the root canal system untouched by instruments, and it improves the mechanical cleaning by increasing the wall shear stress.
NaOCl is used in concentrations between 0.5% - 6%. In high concentrations, it may have a faster dissolution capacity, but it is associated with toxicity in cases of extrusion; thus, methods to improve the action of less concentrated solutions become relevant, such as agitation of the irrigant, constant refreshment and volume, and heating of the solution. Using NaOCl solution at high temperature is related to an increase in reactivity and, therefore, a reduction in bacterial counts and bacterial biofilm dissolution. Although the dentin acts as a thermal insulator, the excessive increase in temperature could dissipate to the periapical tissues, causing damage to the bone tissue .
Initially, it was suggested to heat NaOCl before inserting it into the canals, but this was of little effectiveness .
Woodmansey demonstrated that NaOCl solution can dissolve pulp tissue 210 times faster at boiling temperature (90-120°C) than at room temperature. However, this method remained limited due to the lack of studies confirming its safety until Simeone et al. confirmed that when NaOCl solution is heated inside the canals at a temperature of 150°C for 10 seconds, the temperature of the periodontal tissues does not rise above 42.5°C, which is within the acceptable limits for the periodontal tissue.
Intracanal heating to 180°C using System-B Heat Source shows better antibacterial efficacy than preheated sodium hypochlorite at 60°C. Also, it has been suggested to use low-concentration NaOCl at elevated temperature to report the evidence for better antimicrobial and tissue dissolution properties.
A combination of these two activation methods by ultrasonic agitation of sodium hypochlorite, followed by intracanal heating, may have promising results with regard to the removal of bacteria.
Patients frequently encounter postoperative pain after root canal treatment, and one of the causes is that NaOCl at a higher concentration is irritant to surrounding tissue, particularly in the case of extrusion. Irrigation using lower concentration NaOCl was effective in reducing postoperative pain.
Based on the previous studies, studying the effect of irrigation using low concentration NaOCl (2.6%), which can be activated to increase its reactivity, could give predectible antibacterial effect while reducing postoperative pain and toxicity associated with extrusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intracanal heating for activation using ultrasonics | Active comparator | Device: Ultrasonic activation |
| Intracanal heating for activation using System-B heat carrier | Experimental | Device: System-B |
| Intracanal heating for activation using a combination of ultrasonics and System-B | Experimental | Device: System-B, Device: Ultrasonic activation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- adult male or female patients
- medically free.
- asymptomatic necrotic single rooted teeth
- teeth with mature root
- restorable teeth.
Key exclusion criteria (10 listed)
- Patients with dental related symptoms
- patients with chronic or systemic diseases
- pregnant females.
- multirooted teeth
- vital teeth
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 |
|---|---|---|
| System-BThe irrigation activation by heating is achieved using System-B heat carrier | Device | Intracanal heating for activation using System-B heat carrier, Intracanal heating for activation using a combination of ultrasonics and System-B |
| Ultrasonic activationActivation of irrigation using ultrasonic | Device | Intracanal heating for activation using a combination of ultrasonics and System-B, Intracanal heating for activation using ultrasonics |
Primary outcome
Bacterial reduction
Time frame: after treatment, samples are sent to microbiology lab and bacterial count is measured day 1 after treatment.
Antibacterial effect is evaluated by counting number of bacterial colonies, samples are collected and placed in brain-heart infusion (BHI) broth and subjected to microbiological analysis to determine the colony-forming unit (CFU)/ml
1 secondary outcome
Post-operative pain
Time frame: Post operative pain is measured until day 3 after treatment
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 19 Feb 2026.
- Background: PubMed 39262604Govindaraju L, Shruthi ST, Gopal R, Jenarthanan S, Rajendran MR. Does increase in temperature of sodium hypochlorite have enhanced antimicrobial efficacy and tissue dissolution property? - A systematic review and meta-regression. J Conserv Dent Endod. 2024 Jul;27(7):675-684. doi: 10.4103/JCDE.JCDE_110_24. Epub 2024 Jul 8.
- Background: PubMed 30294123Iandolo A, Amato M, Dagna A, Poggio C, Abdellatif D, Franco V, Pantaleo G. Intracanal heating of sodium hypochlorite: Scanning electron microscope evaluation of root canal walls. J Conserv Dent. 2018 Sep-Oct;21(5):569-573. doi: 10.4103/JCD.JCD_245_18.
- BackgroundRathore, V., Samel, D., Moogi, P., Bandekar, S., Kshirsagar, S., Vyas, C., 2020. Antimicrobial efficacy of intracanal and extracanal heated sodium hypochlorite against Enterococcus faecalis: An in vitro study. Endodontology 32, 112-117. https://doi.org/10.4103/endo.endo_21_20
- Background: PubMed 32201655Yared G, Al Asmar Ramli G. Antibacterial Ability of Sodium Hypochlorite Heated in the Canals of Infected Teeth: An Ex Vivo Study. Cureus. 2020 Feb 13;12(2):e6975. doi: 10.7759/cureus.6975.
- BackgroundSimeone, M., Valletta, A., Giudice, A., Di Lorenzo, P., Iandolo, A., 2015. The activation of irrigation solutions in Endodontics: A perfected technique. G. Ital. Endod. 29, 65-69. https://doi.org/10.1016/j.gien.2015.08.005
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing System-B and Ultrasonic activation in people with Necrotic Teeth, run by Misr University for Science and Technology.
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 10 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: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bacterial reduction (time frame: after treatment, samples are sent to microbiology lab and bacterial count is measured day 1 after treatment.). 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 NCT07420920, 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 19 Feb 2026.