Apical PeriodontitisNCT07921277
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
A study testing Passive Ultrasonic Irrigation (PUI), Standard Needle Irrigation (SNI) and Laser-Activated Irrigation (LAI) in people with Apical Periodontitis and Endodontic Retreatment, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial aims to investigate the effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) on root canal microbiota, host inflammatory responses, postoperative pain, and periapical healing in previously root canal-treated teeth with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apical Periodontitis, Endodontic Retreatment
- What is being tested?
- Passive Ultrasonic Irrigation (PUI), Standard Needle Irrigation (SNI) and Laser-Activated Irrigation (LAI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to May 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- No history of systemic disease.
- Non-smokers.
- Not pregnant or breastfeeding.
- Provision of written informed consent.
- Willingness to attend follow-up appointments for 12 months
Who cannot join
- Teeth with internal or external root resorption.
- Teeth with moderate or severe root canal curvature.
- Teeth with open apices.
- Teeth with periodontal probing depths ≥4 mm.
- Teeth in which adequate rubber dam isolation cannot be achieved.
- Teeth considered non-restorable.
Show all 9Show fewer
- Teeth requiring post retention.
- Teeth with radiographically determined periapical lesions larger than 5.
- Systemic antibiotic or anti-inflammatory medication use within the preceding month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nihan Çelik Uzun, Assistant Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karadeniz Technical University Faculty of Dentistry
Trabzon, Ortahisar
Nihan Çelik Uzun, Assistant Professor, +90 5557256407, nihancelik@ktu.edu.tr
Nihan ÇELİK UZUN, Assistant Professor
About this study
Official title: Molecular and Clinical Evaluation of the Effects of Antimicrobial Photodynamic Therapy Applied Using Different Activation Techniques on the Microbiota and Host Response in Previously Root Canal-Treated Teeth With Apical Periodontitis
This randomized clinical trial aims to investigate the effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) on root canal microbiota, host inflammatory responses, postoperative pain, and periapical healing in previously root canal-treated teeth with asymptomatic apical periodontitis.
A total of 60 participants will be randomly allocated to four groups (15 participants per group): aPDT without additional methylene blue agitation (control), aPDT with standard needle irrigation(SNI), aPDT with passive ultrasonic irrigation (PUI), and aPDT with Er,Cr:YSSG laser-assisted irrigation (LAI).
Read more
All participants will undergo nonsurgical root canal retreatment. Methylene blue will be used as the photosensitizing agent, and photodynamic light irradiation will be performed using the LED FotoSan device in all groups.
Root canal samples will be collected at three treatment stages to investigate changes in microbial communities and inflammatory markers. Shotgun metagenomic sequencing will be performed in a subset of participants, while selected inflammatory cytokines will be measured using enzyme-linked immunosorbent assay (ELISA).
Postoperative pain and radiographic periapical healing will also be evaluated during follow-up.
The study aims to determine whether different methylene blue agitation techniques influence the microbiological, inflammatory, and clinical outcomes of antimicrobial photodynamic therapy during root canal retreatment.
Read the detailed description
This randomized clinical trial will investigate the molecular, microbiological, inflammatory, and clinical effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) in previously root canal-treated permanent teeth with asymptomatic apical periodontitis.
A total of 60 participants will be randomly allocated to four groups (n=15 per group):
Control group: aPDT without additional intracanal methylene blue agitation.
Standard needle irrigation (SNI) group: aPDT with conventional syringe agitation of methylene blue.
Passive ultrasonic irrigation (PUI) group: aPDT with passive ultrasonic agitation of methylene blue.
Laser-activated irrigation (LAI) group: aPDT with Er,Cr:YSSG laser-assisted agitation of methylene blue.
All participants will undergo nonsurgical root canal retreatment, including removal of the previous root canal filling material and chemomechanical preparation. Methylene blue will be introduced into the root canal system as the photosensitizing agent. The assigned intracanal agitation protocol will then be performed, followed by photodynamic light irradiation using the FotoSan device in all groups.
Root canal samples will be collected at three stages: S1, after removal of the previous root canal filling material; S2, after chemomechanical preparation; and S3, following antimicrobial photodynamic therapy.
Shotgun metagenomic sequencing will be performed in a subset of 24 participants, including eight participants from each of the SNI, PUI, and LAI groups. The analysis will investigate microbial taxonomic composition, microbial diversity, functional pathways, antimicrobial resistance genes, and virulence-associated factors.
Host inflammatory responses will be evaluated in all four study groups by measuring interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α) using enzyme-linked immunosorbent assay (ELISA).
Postoperative pain will be assessed using a visual analog scale (VAS) at predefined intervals following treatment. Periapical healing will be evaluated radiographically during the follow-up period.
Within-group changes across sampling points and between-group differences will be evaluated to determine the influence of intracanal methylene blue agitation techniques on microbial communities, host inflammatory responses, postoperative pain, and periapical healing
- Conditions
- Apical Periodontitis, Endodontic Retreatment
- Being tested
- Control - aPDT Without Additional Activation, Passive Ultrasonic Irrigation (PUI), Standard Needle Irrigation (SNI), Laser-Activated Irrigation (LAI)
- Keywords
- Apical Periodontitis, Photodynamic therapy, Photosensitizer activation, Laser, Mediators, Metagenomic shotgun sequencing
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control - aPDT Without Additional ActivationProcedure or surgery
All participants will receive antimicrobial photodynamic therapy (aPDT) using methylene blue as the photosensitizer, followed by photodynamic light irradiation with the FotoSan device. The groups will differ according to the intracanal activation technique applied to methylene blue.
Passive Ultrasonic Irrigation (PUI)Procedure or surgery
Methylene blue will be activated within the root canal using passive ultrasonic irrigation before photodynamic light irradiation with the FotoSan device.
Standard Needle Irrigation (SNI)Procedure or surgery
Methylene blue will be agitated within the root canal using a standard irrigation needle with back-and-forth movements before photodynamic light irradiation with the FotoSan device.
Laser-Activated Irrigation (LAI)Procedure or surgery
ethylene blue will be activated within the root canal using an Er,Cr:YSGG laser-assisted irrigation technique before photodynamic light irradiation with the FotoSan device
| Study group | Role | What they receive |
|---|---|---|
| Control - aPDT Without Additional Activation | Active comparator | Participants will receive antimicrobial photodynamic therapy using methylene blue without additional intracanal agitation, followed by FotoSan light irradiation Receives: Procedure: Control - aPDT Without Additional Activation |
| Standard Needle Irrigation (SNI) | Experimental | Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal agitation of methylene blue using a standard irrigation needle with back-and-forth movements, followed by photodynamic light irradiation using the FotoSan device. Receives: Procedure: Standard Needle Irrigation (SNI) |
| Passive Ultrasonic Irrigation (PUI) | Experimental | Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal activation of methylene blue using passive ultrasonic irrigation, followed by photodynamic light irradiation using the FotoSan device. Receives: Procedure: Passive Ultrasonic Irrigation (PUI) |
| Laser-Activated Irrigation (LAI) | Experimental | Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal activation of methylene blue using an Er, Cr:YSGG laser-assisted irrigation technique, followed by photodynamic light irradiation using the FotoSan device Receives: Procedure: Laser-Activated Irrigation (LAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain). Participants will record their pain intensity at 24 hours, 72 hours, and 1 week after treatment. Mean VAS scores at each time point will be compared among the four treatment groups.
Measured: Up to 7 days after treatment (24 hours, 72 hours, and day 7)
Secondary outcomes (1)
Periapical Radiographic Healing Assessed Using the Periapical Index (PAI)
Periapical radiographic healing will be assessed using digital periapical radiographs obtained with the paralleling technique. Periapical status will be evaluated using the Periapical Index (PAI), scored from 1 (normal periapical structures) to 5 (severe periodontitis with exacerbating features). Teeth with PAI scores of 1 or 2 will be classified as healed, whereas teeth with PAI scores of 3, 4, or 5 will be classified as not healed. Changes in PAI scores will be evaluated over time and compared among treatment groups. Periapical healing will be assessed using the Periapical Index (PAI) before treatment, immediately after treatment, and at 6 and 12 months after treatment.
Measured: From baseline through 12 months after treatment (baseline, immediately post-treatment, month 6, and month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Oct 2026
- Primary completion30 Dec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies 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
- This study is a four-arm, parallel-group, randomized clinical trial involving 60 participants (15 per group). Participants will be randomly assigned to receive antimicrobial photodynamic therapy (aPDT) using one of four intracanal methylene blue agitation protocols: no additional agitation (control), standard Needle Irrigation (SNI), passive ultrasonic irrigation (PUI), or Er,Cr:YSSG laser-assisted irrigation (LAI). All groups will receive photodynamic light irradiation using the FotoSan device. Microbiological, inflammatory, and clinical outcomes will be evaluated.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Çelik Uzun, Karadeniz Technical University
- Investigators
- Nihan Çelik Uzun, Assistant Professor, Principal investigator, Karadeniz Technical University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921277
- Sponsor's protocol ID
- 25-AKD-307
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality. Study findings will be reported in aggregate form in scientific publications
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Clinical Evaluation of the Effects of Antimicrobial Photodynamic Therapy Applied Using Different Activation Techniques on the Microbiota and Host Response in Previously Root Canal-Treated Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07921277
- Acronym / sponsor ID
- 25-AKD-307
- Conditions
- Apical Periodontitis, Endodontic Retreatment
- Keywords
- Apical Periodontitis, Photodynamic therapy, Photosensitizer activation, Laser, Mediators, Metagenomic shotgun sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Nov 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 clinical trial aims to investigate the effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) on root canal microbiota, host inflammatory responses, postoperative pain, and periapical healing in previously root canal-treated teeth with asymptomatic apical periodontitis.
A total of 60 participants will be randomly allocated to four groups (15 participants per group): aPDT without additional methylene blue agitation (control), aPDT with standard needle irrigation(SNI), aPDT with passive ultrasonic irrigation (PUI), and aPDT with Er,Cr:YSSG laser-assisted irrigation (LAI).
All participants will undergo nonsurgical root canal retreatment. Methylene blue will be used as the photosensitizing agent, and photodynamic light irradiation will be performed using the LED FotoSan device in all groups.
Root canal samples will be collected at three treatment stages to investigate changes in microbial communities and inflammatory markers. Shotgun metagenomic sequencing will be performed in a subset of participants, while selected inflammatory cytokines will be measured using enzyme-linked immunosorbent assay (ELISA).
Postoperative pain and radiographic periapical healing will also be evaluated during follow-up.
The study aims to determine whether different methylene blue agitation techniques influence the microbiological, inflammatory, and clinical outcomes of antimicrobial photodynamic therapy during root canal retreatment.
Detailed description
This randomized clinical trial will investigate the molecular, microbiological, inflammatory, and clinical effects of different intracanal methylene blue agitation techniques used during antimicrobial photodynamic therapy (aPDT) in previously root canal-treated permanent teeth with asymptomatic apical periodontitis.
A total of 60 participants will be randomly allocated to four groups (n=15 per group):
Control group: aPDT without additional intracanal methylene blue agitation.
Standard needle irrigation (SNI) group: aPDT with conventional syringe agitation of methylene blue.
Passive ultrasonic irrigation (PUI) group: aPDT with passive ultrasonic agitation of methylene blue.
Laser-activated irrigation (LAI) group: aPDT with Er,Cr:YSSG laser-assisted agitation of methylene blue.
All participants will undergo nonsurgical root canal retreatment, including removal of the previous root canal filling material and chemomechanical preparation. Methylene blue will be introduced into the root canal system as the photosensitizing agent. The assigned intracanal agitation protocol will then be performed, followed by photodynamic light irradiation using the FotoSan device in all groups.
Root canal samples will be collected at three stages: S1, after removal of the previous root canal filling material; S2, after chemomechanical preparation; and S3, following antimicrobial photodynamic therapy.
Shotgun metagenomic sequencing will be performed in a subset of 24 participants, including eight participants from each of the SNI, PUI, and LAI groups. The analysis will investigate microbial taxonomic composition, microbial diversity, functional pathways, antimicrobial resistance genes, and virulence-associated factors.
Host inflammatory responses will be evaluated in all four study groups by measuring interleukin-1 beta (IL-1β), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α) using enzyme-linked immunosorbent assay (ELISA).
Postoperative pain will be assessed using a visual analog scale (VAS) at predefined intervals following treatment. Periapical healing will be evaluated radiographically during the follow-up period.
Within-group changes across sampling points and between-group differences will be evaluated to determine the influence of intracanal methylene blue agitation techniques on microbial communities, host inflammatory responses, postoperative pain, and periapical healing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study is a four-arm, parallel-group, randomized clinical trial involving 60 participants (15 per group). Participants will be randomly assigned to receive antimicrobial photodynamic therapy (aPDT) using one of four intracanal methylene blue agitation protocols: no additional agitation (control), standard Needle Irrigation (SNI), passive ultrasonic irrigation (PUI), or Er,Cr:YSSG laser-assisted irrigation (LAI). All groups will receive photodynamic light irradiation using the FotoSan device. Microbiological, inflammatory, and clinical outcomes will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Control - aPDT Without Additional Activation | Active comparator | Procedure: Control - aPDT Without Additional ActivationParticipants will receive antimicrobial photodynamic therapy using methylene blue without additional intracanal agitation, followed by FotoSan light irradiation |
| Standard Needle Irrigation (SNI) | Experimental | Procedure: Standard Needle Irrigation (SNI)Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal agitation of methylene blue using a standard irrigation needle with back-and-forth movements, followed by photodynamic light irradiation using the FotoSan device. |
| Passive Ultrasonic Irrigation (PUI) | Experimental | Procedure: Passive Ultrasonic Irrigation (PUI)Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal activation of methylene blue using passive ultrasonic irrigation, followed by photodynamic light irradiation using the FotoSan device. |
| Laser-Activated Irrigation (LAI) | Experimental | Procedure: Laser-Activated Irrigation (LAI)Participants will receive antimicrobial photodynamic therapy (aPDT) with intracanal activation of methylene blue using an Er, Cr:YSGG laser-assisted irrigation technique, followed by photodynamic light irradiation using the FotoSan device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-65 years.
- No history of systemic disease.
- Non-smokers.
- Not pregnant or breastfeeding.
- Provision of written informed consent.
Key exclusion criteria (9 listed)
- Teeth with internal or external root resorption.
- Teeth with moderate or severe root canal curvature.
- Teeth with open apices.
- Teeth with periodontal probing depths ≥4 mm.
- Teeth in which adequate rubber dam isolation cannot be achieved.
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 |
|---|---|---|
| Control - aPDT Without Additional ActivationAll participants will receive antimicrobial photodynamic therapy (aPDT) using methylene blue as the photosensitizer, followed by photodynamic light irradiation with the FotoSan device. The groups will differ according to the intracanal activation technique applied to methylene blue. | Procedure or surgery | Control - aPDT Without Additional Activation |
| Passive Ultrasonic Irrigation (PUI)Methylene blue will be activated within the root canal using passive ultrasonic irrigation before photodynamic light irradiation with the FotoSan device. | Procedure or surgery | Passive Ultrasonic Irrigation (PUI) |
| Standard Needle Irrigation (SNI)Methylene blue will be agitated within the root canal using a standard irrigation needle with back-and-forth movements before photodynamic light irradiation with the FotoSan device. | Procedure or surgery | Standard Needle Irrigation (SNI) |
| Laser-Activated Irrigation (LAI)ethylene blue will be activated within the root canal using an Er,Cr:YSGG laser-assisted irrigation technique before photodynamic light irradiation with the FotoSan device | Procedure or surgery | Laser-Activated Irrigation (LAI) |
Primary outcome
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS)
Time frame: Up to 7 days after treatment (24 hours, 72 hours, and day 7)
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain). Participants will record their pain intensity at 24 hours, 72 hours, and 1 week after treatment. Mean VAS scores at each time point will be compared among the four treatment groups.
1 secondary outcome
Periapical Radiographic Healing Assessed Using the Periapical Index (PAI)
Time frame: From baseline through 12 months after treatment (baseline, immediately post-treatment, month 6, and month 12)
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers to protect participant privacy and confidentiality. Study findings will be reported in aggregate form in scientific publications
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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.
Nihan Çelik Uzun, Assistant Professor contact
Nihan Çelik Uzun, Assistant Professor principal investigator
Karadeniz Technical University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Ultrasonic Irrigation (PUI), Standard Needle Irrigation (SNI) and Laser-Activated Irrigation (LAI) in people with Apical Periodontitis and Endodontic Retreatment, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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 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: looking for participants now, as of the sponsor's last update on 6 Nov 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 Turkey (Türkiye). 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?
Contact Nihan Çelik Uzun, Assistant Professor (+90 5557256407 ext. +90 4623774813, nihancelik@ktu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Assessed Using a Visual Analog Scale (VAS) (time frame: Up to 7 days after treatment (24 hours, 72 hours, and day 7)). 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 6 Nov 2026.