Dental Pulp NecrosisPDT-NaOClNCT07666932
Antimicrobial Efficacy of NaOCl and PDT in Primary Root Canal Treatment
A study testing Sodium Hypochlorite Irrigation, Sodium Hypochlorite Irrigation Plus Photodynamic Therapy and Photodynamic Therapy Adjunct Evaluation in people with Dental Pulp Necrosis and Apical Periodontitis, run by Bayan Alqrenawi at 1 site in Jordan.
Trial summary
This clinical study will compare different root canal disinfection methods used during primary root canal treatment. Root canal infection is mainly caused by bacteria inside the root canal system. Sodium hypochlorite is commonly used as a root canal irrigant because it helps reduce bacteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Pulp Necrosis, Apical Periodontitis
- What is being tested?
- Sodium Hypochlorite Irrigation, Sodium Hypochlorite Irrigation Plus Photodynamic Therapy and Photodynamic Therapy Adjunct Evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteJordan
- Study dates
- 19 May 2025to 20 Apr 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 70 years.
- Medically healthy patients or patients with well-controlled systemic conditions, such as controlled diabetes or controlled hypertension.
- Patients requiring primary root canal treatment in mature, single-rooted, single-canal teeth.
- Teeth with a confirmed diagnosis of pulp necrosis, with or without apical periodontitis.
- Teeth that are restorable.
- Teeth suitable for single-visit root canal treatment.
Show all 9Show fewer
- Teeth suitable for rubber dam isolation.
- Cases with dry canals that do not require inter-appointment medication.
- Participants who provide written informed consent before treatment.
Who cannot join
- Patients with uncontrolled systemic disease.
- Patients with immunocompromised status.
- Patients with any condition that could affect infection, healing, or treatment response.
- Patients who used systemic antibiotics within the previous three months.
- Patients who used analgesic or anti-inflammatory medication shortly before treatment.
- Pregnant or lactating patients.
Show all 18Show fewer
- Patients with known allergy or contraindication to any study material.
- Teeth with irreversible pulpitis.
- Teeth with previous root canal treatment or retreatment indication.
- Teeth with immature apices.
- Teeth with internal or external root resorption.
- Teeth with cracks, fractures, or perforations.
- Teeth with unusual canal anatomy that could prevent procedural standardization.
- Teeth with advanced periodontal involvement.
- Teeth with unrestorable coronal structure.
- Canals with persistent exudate.
- Cases with acute swelling or acute abscess.
- Any condition requiring multi-visit treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Study of the Antimicrobial Efficacy of Sodium Hypochlorite and Sodium Hypochlorite Supplemented With Photodynamic Therapy in Eliminating Bacteria in Primary Root Canal Treatment: An In Vivo Study
This clinical study will compare different root canal disinfection methods used during primary root canal treatment. Root canal infection is mainly caused by bacteria inside the root canal system. Sodium hypochlorite is commonly used as a root canal irrigant because it helps reduce bacteria. Photodynamic therapy is an additional disinfection method that uses a photosensitizing solution and light activation to help kill bacteria. Participants who need primary root canal treatment will be randomly assigned to one of the study groups. The study will compare sodium hypochlorite irrigation alone with sodium hypochlorite supplemented with photodynamic therapy. Additional comparison groups will be used to assess the antimicrobial effect of the disinfection procedures. Bacterial samples will be collected from the root canals before and after the assigned disinfection protocol to measure the reduction in bacterial counts. The main outcome of the study is the reduction in intracanal bacterial load after the disinfection procedure. Postoperative pain will also be assessed using a visual analogue scale at selected time points after treatment. All participants will receive standard root canal treatment, and the final clinical disinfection and treatment procedures will be completed according to accepted endodontic practice.
Read the detailed description
This is an in vivo randomized clinical study designed to evaluate the antimicrobial effect of root canal disinfection protocols during primary root canal treatment. The study focuses on the reduction of viable intracanal bacteria following irrigation with sodium hypochlorite, with or without adjunctive photodynamic therapy. Eligible participants requiring primary root canal treatment will be enrolled and randomly allocated to one of the study groups according to the approved protocol. Under rubber dam isolation, root canal treatment will be performed using standard endodontic procedures. Intracanal microbiological samples will be collected using sterile paper points before and after the assigned disinfection protocol. The collected samples will be processed for culture-based microbiological analysis, and bacterial reduction will be assessed by comparing viable bacterial counts before and after the intervention. Photodynamic therapy will be used as an adjunctive disinfection method in the relevant study group. This technique involves the use of a photosensitizing agent followed by activation with light of an appropriate wavelength to produce an antimicrobial effect. Sodium hypochlorite irrigation will be used as the standard chemical disinfection method. For ethical and clinical safety reasons, all participants will receive completion of treatment according to accepted endodontic standards. Postoperative pain will be recorded after treatment using a visual analogue scale. The study is intended to determine whether adding photodynamic therapy to sodium hypochlorite improves intracanal bacterial reduction compared with sodium hypochlorite irrigation alone during primary root canal treatment.
- Conditions
- Dental Pulp Necrosis, Apical Periodontitis
- Being tested
- Sodium Hypochlorite Irrigation, Sodium Hypochlorite Irrigation Plus Photodynamic Therapy, Photodynamic Therapy Adjunct Evaluation, Saline Irrigation Control
- Keywords
- Photodynamic therapy, Antimicrobial photodynamic therapy, Sodium hypochlorite, Bacterial reduction
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Hypochlorite IrrigationProcedure or surgery
Root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment.
Sodium Hypochlorite Irrigation Plus Photodynamic TherapyProcedure or surgery
Root canal disinfection using 3% sodium hypochlorite irrigation followed by adjunctive photodynamic therapy using a photosensitizing agent and light activation.
Photodynamic Therapy Adjunct EvaluationProcedure or surgery
Antimicrobial photodynamic therapy using a photosensitizing agent and light activation as an adjunctive disinfection evaluation step during primary root canal treatment.
Saline Irrigation ControlOther
Sterile 0.9% saline irrigation used as a negative-control procedure before microbiological sampling.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Hypochlorite Irrigation | Experimental | Participants assigned to this arm will receive root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment. Receives: Procedure: Sodium Hypochlorite Irrigation |
| Sodium Hypochlorite Plus Photodynamic Therapy | Experimental | Participants assigned to this arm will receive 3% sodium hypochlorite irrigation supplemented with adjunctive photodynamic therapy during primary root canal treatment. Receives: Procedure: Sodium Hypochlorite Irrigation Plus Photodynamic Therapy |
| Photodynamic Therapy Adjunct Evaluation | Experimental | Participants assigned to this arm will receive photodynamic therapy as the assigned antimicrobial evaluation step, followed by completion of standard root canal disinfection and treatment according to the approved protocol. Receives: Procedure: Photodynamic Therapy Adjunct Evaluation |
| Saline Control | Placebo comparator | Participants assigned to this arm will receive sterile saline irrigation as a negative-control procedure before microbiological sampling, followed by completion of standard root canal disinfection and treatment according to the approved protocol. Receives: Other: Saline Irrigation Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intracanal Bacterial Load
Intracanal bacterial load will be assessed using culture-based microbiological analysis of root canal samples collected with sterile paper points. Viable bacterial counts will be expressed as log10 colony-forming units (CFU). The primary outcome will be the reduction in bacterial load, calculated as the difference between baseline log10 CFU and post-disinfection log10 CFU values.
Measured: From baseline intracanal sampling before the assigned disinfection protocol to immediately after completion of the assigned disinfection protocol during the same root canal treatment visit.
Secondary outcomes (1)
Change in Pain Intensity From Baseline to 24 Hours After Root Canal Treatment
Pain intensity will be assessed using a 10-cm visual analogue scale. Participants will record their pain level before treatment and 24 hours after treatment. The change in pain score will be calculated by comparing the baseline preoperative pain score with the 24-hour postoperative pain score.
Measured: Baseline before treatment and 24 hours after completion of root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start19 May 2025
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosisStudies 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
- Model description
- Participants will be randomly assigned in a parallel-group design to one of the study intervention groups. Each participant will receive only the assigned root canal disinfection protocol, and there will be no crossover between groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayan Alqrenawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bayan Alqrenawi, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666932
- Sponsor's protocol ID
- 10/2025/5586
- Acronym
- PDT-NaOCl
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Only aggregated and analyzed study results may be reported in the thesis, scientific presentations, or publications.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of the Antimicrobial Efficacy of Sodium Hypochlorite and Sodium Hypochlorite Supplemented With Photodynamic Therapy in Eliminating Bacteria in Primary Root Canal Treatment: An In Vivo Study
- ClinicalTrials.gov ID
- NCT07666932
- Acronym / sponsor ID
- PDT-NaOCl / 10/2025/5586
- Conditions
- Dental Pulp Necrosis, Apical Periodontitis
- Keywords
- Photodynamic therapy, Antimicrobial photodynamic therapy, Sodium hypochlorite, Bacterial reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bayan AlqrenawiUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 24 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 clinical study will compare different root canal disinfection methods used during primary root canal treatment. Root canal infection is mainly caused by bacteria inside the root canal system. Sodium hypochlorite is commonly used as a root canal irrigant because it helps reduce bacteria. Photodynamic therapy is an additional disinfection method that uses a photosensitizing solution and light activation to help kill bacteria. Participants who need primary root canal treatment will be randomly assigned to one of the study groups. The study will compare sodium hypochlorite irrigation alone with sodium hypochlorite supplemented with photodynamic therapy. Additional comparison groups will be used to assess the antimicrobial effect of the disinfection procedures. Bacterial samples will be collected from the root canals before and after the assigned disinfection protocol to measure the reduction in bacterial counts. The main outcome of the study is the reduction in intracanal bacterial load after the disinfection procedure. Postoperative pain will also be assessed using a visual analogue scale at selected time points after treatment. All participants will receive standard root canal treatment, and the final clinical disinfection and treatment procedures will be completed according to accepted endodontic practice.
Detailed description
This is an in vivo randomized clinical study designed to evaluate the antimicrobial effect of root canal disinfection protocols during primary root canal treatment. The study focuses on the reduction of viable intracanal bacteria following irrigation with sodium hypochlorite, with or without adjunctive photodynamic therapy. Eligible participants requiring primary root canal treatment will be enrolled and randomly allocated to one of the study groups according to the approved protocol. Under rubber dam isolation, root canal treatment will be performed using standard endodontic procedures. Intracanal microbiological samples will be collected using sterile paper points before and after the assigned disinfection protocol. The collected samples will be processed for culture-based microbiological analysis, and bacterial reduction will be assessed by comparing viable bacterial counts before and after the intervention. Photodynamic therapy will be used as an adjunctive disinfection method in the relevant study group. This technique involves the use of a photosensitizing agent followed by activation with light of an appropriate wavelength to produce an antimicrobial effect. Sodium hypochlorite irrigation will be used as the standard chemical disinfection method. For ethical and clinical safety reasons, all participants will receive completion of treatment according to accepted endodontic standards. Postoperative pain will be recorded after treatment using a visual analogue scale. The study is intended to determine whether adding photodynamic therapy to sodium hypochlorite improves intracanal bacterial reduction compared with sodium hypochlorite irrigation alone during primary root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned in a parallel-group design to one of the study intervention groups. Each participant will receive only the assigned root canal disinfection protocol, and there will be no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Sodium Hypochlorite Irrigation | Experimental | Procedure: Sodium Hypochlorite IrrigationParticipants assigned to this arm will receive root canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment. |
| Sodium Hypochlorite Plus Photodynamic Therapy | Experimental | Procedure: Sodium Hypochlorite Irrigation Plus Photodynamic TherapyParticipants assigned to this arm will receive 3% sodium hypochlorite irrigation supplemented with adjunctive photodynamic therapy during primary root canal treatment. |
| Photodynamic Therapy Adjunct Evaluation | Experimental | Procedure: Photodynamic Therapy Adjunct EvaluationParticipants assigned to this arm will receive photodynamic therapy as the assigned antimicrobial evaluation step, followed by completion of standard root canal disinfection and treatment according to the approved protocol. |
| Saline Control | Placebo comparator | Other: Saline Irrigation ControlParticipants assigned to this arm will receive sterile saline irrigation as a negative-control procedure before microbiological sampling, followed by completion of standard root canal disinfection and treatment according to the approved protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 18 to 70 years.
- Medically healthy patients or patients with well-controlled systemic conditions, such as controlled diabetes or controlled hypertension.
- Patients requiring primary root canal treatment in mature, single-rooted, single-canal teeth.
- Teeth with a confirmed diagnosis of pulp necrosis, with or without apical periodontitis.
- Teeth that are restorable.
Key exclusion criteria (18 listed)
- Patients with uncontrolled systemic disease.
- Patients with immunocompromised status.
- Patients with any condition that could affect infection, healing, or treatment response.
- Patients who used systemic antibiotics within the previous three months.
- Patients who used analgesic or anti-inflammatory medication shortly before treatment.
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 |
|---|---|---|
| Sodium Hypochlorite IrrigationRoot canal disinfection using 3% sodium hypochlorite irrigation during primary root canal treatment. | Procedure or surgery | Sodium Hypochlorite Irrigation |
| Sodium Hypochlorite Irrigation Plus Photodynamic TherapyRoot canal disinfection using 3% sodium hypochlorite irrigation followed by adjunctive photodynamic therapy using a photosensitizing agent and light activation. | Procedure or surgery | Sodium Hypochlorite Plus Photodynamic Therapy |
| Photodynamic Therapy Adjunct EvaluationAntimicrobial photodynamic therapy using a photosensitizing agent and light activation as an adjunctive disinfection evaluation step during primary root canal treatment. | Procedure or surgery | Photodynamic Therapy Adjunct Evaluation |
| Saline Irrigation ControlSterile 0.9% saline irrigation used as a negative-control procedure before microbiological sampling. | Other | Saline Control |
Primary outcome
Change in Intracanal Bacterial Load
Time frame: From baseline intracanal sampling before the assigned disinfection protocol to immediately after completion of the assigned disinfection protocol during the same root canal treatment visit.
Intracanal bacterial load will be assessed using culture-based microbiological analysis of root canal samples collected with sterile paper points. Viable bacterial counts will be expressed as log10 colony-forming units (CFU). The primary outcome will be the reduction in bacterial load, calculated as the difference between baseline log10 CFU and post-disinfection log10 CFU values.
1 secondary outcome
Change in Pain Intensity From Baseline to 24 Hours After Root Canal Treatment
Time frame: Baseline before treatment and 24 hours after completion of root canal treatment
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 1 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Only aggregated and analyzed study results may be reported in the thesis, scientific presentations, or publications.
Related trials for Dental Pulp Necrosis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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 Sodium Hypochlorite Irrigation, Sodium Hypochlorite Irrigation Plus Photodynamic Therapy and Photodynamic Therapy Adjunct Evaluation in people with Dental Pulp Necrosis and Apical Periodontitis, run by Bayan Alqrenawi at 1 site in Jordan.
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 9 inclusion and 18 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 1 Jul 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 Jordan. 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. Some participants in this study may receive a placebo. 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?
Change in Intracanal Bacterial Load (time frame: From baseline intracanal sampling before the assigned disinfection protocol to immediately after completion of the assigned disinfection protocol during the same root canal treatment visit.). 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 1 Jul 2026.