Photodynamic Therapy and Post-Endodontic Pain in Undergraduate-Performed Treatments (PDT)

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis
• Intervention / Treatment: Device: Photodynamic Therapy

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 Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kağıthane
    • Istanbul, Kağıthane, Turkey (Türkiye), 34400
      • Ayfer ATAV ATEŞ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Photodynamic Therapy; 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).
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).	Device: Photodynamic Therapy; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Time Frame: 6, 24, 48, and 72 hours after treatment Unit of Measure: VAS score (0-10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic Consumption (Number of Tablets Taken)	The number of analgesic tablets consumed by each participant during the postoperative period will be recorded.	Up to 72 hours after treatment

Collaborators and Investigators

• Sponsor: Atlas University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Postendodontic pain
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Dental Pulp Diseases; Tooth Diseases; Pulpitis; Therapeutics; Drug Therapy; Combined Modality Therapy; Phototherapy; Photochemotherapy
• Other Study ID Numbers: E-22686390-050.99-78516 (Other Identifier: Istanbul Atlas University Non-Interventional Scientific Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No