Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-06 @ 6:08 AM
Study NCT ID:
NCT07254260
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy and Post-Endodontic Pain in Undergraduate-Performed Treatments
Sponsor:
Atlas University
Organization:
Study Overview
Official Title:
Photodynamic Therapy (PDT) and Postendodontic Pain
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDT
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| E-22686390-050.99-78516 | OTHER | Istanbul Atlas University Non-Interventional Scientific Research Ethics Committee | View |