PulpitisPDTNCT07254260
Photodynamic Therapy and Post-Endodontic Pain in Undergraduate-Performed Treatments
An observational study of Pulpitis, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
To compare the intensity and trajectory of postoperative pain (0-72 hours) between (A) a conventional final irrigation protocol without activation and (B) a PDT-augmented final disinfection in mandibular molars and premolars. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Photodynamic Therapy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 95 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients aged 18-60 years who received primary endodontic treatment of mandibular premolars or molars at the Istanbul Atlas University Faculty of Dentistry student clinic. All treatments were performed by undergraduate dental students under supervision. Eligible patients had no systemic diseases and presented with teeth requiring primary root canal therapy without intraoperative complications.
Who may be able to join
- Adults aged 18-60 years Patients requiring primary endodontic treatment of posterior teeth (premolars or molars) Patients without systemic diseases Patients treated at the Istanbul Atlas University Faculty of Dentistry student clinic Teeth with no intraoperative complications (no perforation, no instrument separation, no ledge formation) Treatments completed with either photodynamic therapy (PDT) activation or no activation (control group)
Who cannot join
- Teeth with previous root canal treatment Teeth with open apices Presence of severe periodontal disease Incomplete clinical or radiographic records Patients with systemic conditions that may influence postoperative pain perception Any intraoperative complications during treatment (perforation, ledge, instrument separation, etc.) Presence of acute apical abscess
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Photodynamic Therapy (PDT) and Postendodontic Pain
To compare the intensity and trajectory of postoperative pain (0-72 hours) between (A) a conventional final irrigation protocol without activation and (B) a PDT-augmented final disinfection in mandibular molars and premolars.
Read the detailed description
This retrospective controlled clinical cohort study investigated the effects of photodynamic therapy (PDT) on post-endodontic pain in mandibular molars and premolars treated by undergraduate students. Eligible patients were selected from the Istanbul Atlas University Faculty of Dentistry clinics. Inclusion criteria encompassed adult patients requiring endodontic treatment in posterior teeth, without systemic contraindications or signs of acute apical abscess.
Participants were assigned to one of two groups:
(A) conventional final irrigation without activation (control), and (B) PDT-augmented final disinfection (experimental).
All treatments were performed by undergraduate dental students under faculty supervision. Root canals were shaped using a standardized rotary instrumentation protocol. In both groups, final irrigation included 2.5% sodium hypochlorite (NaOCl), followed by 17% EDTA for smear layer removal.
In the experimental group, after completion of the same irrigation regimen, a methylene blue photosensitizer was introduced into the canal and allowed to remain for 60 seconds. The dye was subsequently activated using an intra-canal diode laser fiber for 60 seconds per canal, following manufacturer instructions for photodynamic therapy. All canals were obturated at the second visit using the single-cone technique.
Postoperative pain was measured using a visual analog scale (VAS) at 6, 24, 48, and 72 hours after treatment. Additional variables such as analgesic consumption, incidence of flare-ups, unscheduled visits, and the time required to achieve a pain-free state were also recorded. This study aimed to determine whether adjunctive PDT could reduce early post-endodontic pain in treatments performed by undergraduate practitioners.
- Conditions
- Pulpitis
- Being tested
- Photodynamic Therapy
- Keywords
- Postendodontic pain
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic TherapyDevice
the Easyinsmile endo-type light guard tip (diameter: 200 µm; emission wavelength: 630 ± 10 nm; optical power density: approximately 100 mW/cm²) was inserted into the canal. Photoactivation was then performed for 30 seconds per canal (10 second periods x 3).
| Study group | Role | What they receive |
|---|---|---|
| Conventional Final Irrigation Without Activation (Control Group) | The final irrigation protocol consisted of sequential rinses with saline, 17% ethylenediaminetetraacetic acid (EDTA; Wizard, Turkey), and distilled water and 2.5% sodium hypochlorite (NaOCl; Wizard, Turkey), which was activated during this step, followed by a final flush with saline solution. Receives: Device: Photodynamic Therapy | |
| Brief Title: The Effect of Photodynamic Therapy on Post-Endodontic Pain in Treatments P | Following completion of standard chemomechanical preparation and photodynamic therapy (PDT) was performed using the Easyinsmile Photodynamic PDT 630 System (Easyinsmile Co., Ltd., Changsha, Hunan, China). A low-range photosensitizer solution (Easyinsmile Photosensitizer, methylene blue-based formulation, λ_max = 630 nm) was delivered into each prepared root canal using the dedicated delivery syringe tip provided with the photosensitizer, ensuring precise, controlled placement of the agent while minimizing the risk of apical extrusion. The Easyinsmile endo-type light guard tip (diameter: 200 µm; emission wavelength: 630 ± 10 nm; optical power density: approximately 100 mW/cm²) was inserted into the canal. Photoactivation was then performed for 30 seconds per canal (10-second periods x 3). Receives: Device: Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (Visual Analog Scale - VAS)
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst pain imaginable." Higher scores indicate greater pain intensity.
Measured: Time Frame: 6, 24, 48, and 72 hours after treatment Unit of Measure: VAS score (0-10)
Secondary outcomes (1)
Analgesic Consumption (Number of Tablets Taken)
The number of analgesic tablets consumed by each participant during the postoperative period will be recorded.
Measured: Up to 72 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayfer Atav, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254260
- Sponsor's protocol ID
- E-22686390-050.99-78516
- Other IDs
- E-22686390-050.99-78516
- Acronym
- PDT
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiniforush N, Pourhajibagher M, Shahabi S, Kosarieh E, Bahador A. Can Antimicrobial Photodynamic Therapy (aPDT) Enhance the Endodontic Treatment? J Lasers Med Sci. 2016 Spring;7(2):76-85. doi: 10.15171/jlms.2016.14. Epub 2016 Mar 27.
PubMed 27330702Ovsay E, Atav A, Pamuk DM. The effect of photodynamic therapy on post-endodontic pain in treatments performed by undergraduate students. BMC Oral Health. 2026 Jul 23;26(1):1523. doi: 10.1186/s12903-026-09374-4.
PubMed 42625164
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy (PDT) and Postendodontic Pain
- ClinicalTrials.gov ID
- NCT07254260
- Acronym / sponsor ID
- PDT / E-22686390-050.99-78516
- Conditions
- Pulpitis
- Keywords
- Postendodontic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the intensity and trajectory of postoperative pain (0-72 hours) between (A) a conventional final irrigation protocol without activation and (B) a PDT-augmented final disinfection in mandibular molars and premolars.
Detailed description
This retrospective controlled clinical cohort study investigated the effects of photodynamic therapy (PDT) on post-endodontic pain in mandibular molars and premolars treated by undergraduate students. Eligible patients were selected from the Istanbul Atlas University Faculty of Dentistry clinics. Inclusion criteria encompassed adult patients requiring endodontic treatment in posterior teeth, without systemic contraindications or signs of acute apical abscess.
Participants were assigned to one of two groups:
(A) conventional final irrigation without activation (control), and (B) PDT-augmented final disinfection (experimental).
All treatments were performed by undergraduate dental students under faculty supervision. Root canals were shaped using a standardized rotary instrumentation protocol. In both groups, final irrigation included 2.5% sodium hypochlorite (NaOCl), followed by 17% EDTA for smear layer removal.
In the experimental group, after completion of the same irrigation regimen, a methylene blue photosensitizer was introduced into the canal and allowed to remain for 60 seconds. The dye was subsequently activated using an intra-canal diode laser fiber for 60 seconds per canal, following manufacturer instructions for photodynamic therapy. All canals were obturated at the second visit using the single-cone technique.
Postoperative pain was measured using a visual analog scale (VAS) at 6, 24, 48, and 72 hours after treatment. Additional variables such as analgesic consumption, incidence of flare-ups, unscheduled visits, and the time required to achieve a pain-free state were also recorded. This study aimed to determine whether adjunctive PDT could reduce early post-endodontic pain in treatments performed by undergraduate practitioners.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Final Irrigation Without Activation (Control Group) | – | Device: Photodynamic TherapyThe final irrigation protocol consisted of sequential rinses with saline, 17% ethylenediaminetetraacetic acid (EDTA; Wizard, Turkey), and distilled water and 2.5% sodium hypochlorite (NaOCl; Wizard, Turkey), which was activated during this step, followed by a final flush with saline solution. |
| Brief Title: The Effect of Photodynamic Therapy on Post-Endodontic Pain in Treatments P | – | Device: Photodynamic TherapyFollowing completion of standard chemomechanical preparation and photodynamic therapy (PDT) was performed using the Easyinsmile Photodynamic PDT 630 System (Easyinsmile Co., Ltd., Changsha, Hunan, China). A low-range photosensitizer solution (Easyinsmile Photosensitizer, methylene blue-based formulation, λ_max = 630 nm) was delivered into each prepared root canal using the dedicated delivery syringe tip provided with the photosensitizer, ensuring precise, controlled placement of the agent while minimizing the risk of apical extrusion. The Easyinsmile endo-type light guard tip (diameter: 200 µm; emission wavelength: 630 ± 10 nm; optical power density: approximately 100 mW/cm²) was inserted into the canal. Photoactivation was then performed for 30 seconds per canal (10-second periods x 3). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged 18-60 years who received primary endodontic treatment of mandibular premolars or molars at the Istanbul Atlas University Faculty of Dentistry student clinic. All treatments were performed by undergraduate dental students under supervision. Eligible patients had no systemic diseases and presented with teeth requiring primary root canal therapy without intraoperative complications.
Key inclusion criteria (1 listed)
- Adults aged 18-60 years Patients requiring primary endodontic treatment of posterior teeth (premolars or molars) Patients without systemic diseases Patients treated at the Istanbul Atlas University Faculty of Dentistry student clinic Teeth with no intraoperative complications (no perforation, no instrument separation, no ledge formation) Treatments completed with either photodynamic therapy (PDT) activation or no activation (control group)
Key exclusion criteria (1 listed)
- Teeth with previous root canal treatment Teeth with open apices Presence of severe periodontal disease Incomplete clinical or radiographic records Patients with systemic conditions that may influence postoperative pain perception Any intraoperative complications during treatment (perforation, ledge, instrument separation, etc.) Presence of acute apical abscess
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 |
|---|---|---|
| Photodynamic Therapythe Easyinsmile endo-type light guard tip (diameter: 200 µm; emission wavelength: 630 ± 10 nm; optical power density: approximately 100 mW/cm²) was inserted into the canal. Photoactivation was then performed for 30 seconds per canal (10 second periods x 3). | Device | Brief Title: The Effect of Photodynamic Therapy on Post-Endodontic Pain in Treatments P, Conventional Final Irrigation Without Activation (Control Group) |
Primary outcome
Postoperative Pain Intensity (Visual Analog Scale - VAS)
Time frame: Time Frame: 6, 24, 48, and 72 hours after treatment Unit of Measure: VAS score (0-10)
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst pain imaginable." Higher scores indicate greater pain intensity.
1 secondary outcome
Analgesic Consumption (Number of Tablets Taken)
Time frame: Up to 72 hours after 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 28 Nov 2025.
- Results publication: PubMed 27330702Chiniforush N, Pourhajibagher M, Shahabi S, Kosarieh E, Bahador A. Can Antimicrobial Photodynamic Therapy (aPDT) Enhance the Endodontic Treatment? J Lasers Med Sci. 2016 Spring;7(2):76-85. doi: 10.15171/jlms.2016.14. Epub 2016 Mar 27.
- Derived from this study: PubMed 42625164Ovsay E, Atav A, Pamuk DM. The effect of photodynamic therapy on post-endodontic pain in treatments performed by undergraduate students. BMC Oral Health. 2026 Jul 23;26(1):1523. doi: 10.1186/s12903-026-09374-4.
- Individual participant dataSharing planned: No
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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?
An observational study of Pulpitis, run by Atlas 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 1 inclusion and 1 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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?
Postoperative Pain Intensity (Visual Analog Scale - VAS) (time frame: Time Frame: 6, 24, 48, and 72 hours after treatment Unit of Measure: VAS score (0-10)). 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 NCT07254260, which also lists 2 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 28 Nov 2025.