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

NCT07254260 | Completed DMC

• 1 other identifier: E-22686390-050.99-78516
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpitis

Keywords

Postendodontic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Analgesic Consumption (Number of Tablets Taken)

  Up to 72 hours after treatment

Study Arms (2)

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

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

Interventions

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).

Brief Title: The Effect of Photodynamic Therapy on Post-Endodontic Pain in Treatments P; Conventional Final Irrigation Without Activation (Control Group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Ayfer ATAV ATEŞ

Istanbul, Kağıthane, 34400, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 27330702 RESULT

MeSH Terms

Conditions

Pulpitis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 28, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)