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Completed

NCT Number: NCT07254260

Photodynamic Therapy and Post-Endodontic Pain in Undergraduate-Performed Treatments

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ayfer ATAV ATEŞ

Istanbul, Kağıthane, 34400, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photodynamic therapy

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Analgesic Consumption (Number of Tablets Taken)

    Time frame: Up to 72 hours after treatment

    The number of analgesic tablets consumed by each participant during the postoperative period will be recorded.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Photodynamic Therapy (PDT) and Postendodontic Pain

Acronym: PDT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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