Postoperative Pain in Photodynamic Therapy Using Curcumin As a Photosensitizer

The Effect of Photodynamic Therapy Using Curcumin As a Photosensitizer on Postoperative Pain After Non-Surgical Root Canal Retreatment: a Randomized Controlled Clinical Trial

In endodontics, various irrigation solutions are used to achieve antibacterial efficacy within the root canal. The antibacterial effect of curcumin-containing root canal solutions, when combined with photodynamic therapy, has been demonstrated in several studies. However, no research has specifically examined their effect on postoperative pain. The aim of this study is to investigate the impact of using a curcumin solution in combination with photodynamic therapy as the final irrigation solution on postoperative pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Periapical Diseases; Postoperative Dental Pain; Photodynamic Therapy (PDT); Irrigation Solution
• Intervention / Treatment: Other: Curcumin with photodynamic thearpy; Other: Control group

Detailed Description

Fifty patients were randomly assigned to two groups using a web-based program, according to the selected final irrigation procedure: curcumin-photodynamic therapy or a control group (routine root canal final irrigation with NaOCl and EDTA). The teeth will be isolated with a rubber dam, and access cavities will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will then be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem Sumbullu, DDS; Phone Number: +90 442 231 1111; Email: meltem_endo@hotmail.com
• Study Contact Backup: Name: Tuğçe Sönmez, DDS; Phone Number: +90 442 236 0942; Email: dishek@atauni.edu.tr

Study Locations

• Turkey
  • Yakutiye
    • Erzurum, Yakutiye, Turkey, 25240
      • Ataturk University
      • Contact: meltem çolak, DDS, pHD; Phone Number: +90 442 236 0940; Email: neltem25@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• healthy patients with aged between 18-60.
• Incisor, canine, and premolar teeth that had previously undergone root canal treatment
• Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
• teeth with only 1 root canal
• the patients had not used any antibiotics for 3 months before treatment

Exclusion Criteria:

• the presence of a root fracture
• teeth with any swelling
• ankyloses,
• periodontal pockets deeper than 4 mm.
• teeth which a rubber dam could not be performed
• patients with allergy to ibuprofen or ciprofloxacin were also excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Curcumin with photodynamic therapy; Root canal lengths will be determined using an electronic apex locator with a 15-K file. R25 and R50 Reciproc files will be used at working lengths to complete the canal preparation. During instrumentation, the root canals will be irrigated with 2 mL of 1% NaOCl. Subsequently, the root canals will be dried with paper points, and the final irrigation procedure will be performed using a curcumin solution in combination with photodynamic therapy. The root canals will then be filled with gutta-percha and sealer, and the coronal restoration will be completed. Patients will be provided with a form to assess postoperative pain and asked to score it daily. The completed form will be requested after one week.	Other: Curcumin with photodynamic thearpy; root canals will irrigated with final irrigation procedure: curcumin+photodynamic therapy. The teeth will be isolated with a rubber dam, and an access cavity will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.
Active Comparator: control group; Root canal lengths will be determined using an electronic apex locator with a 15-K file. R25 and R50 Reciproc files will be used at working lengths to remove the canal filling. During instrumentation, the root canals will be irrigated with 2 mL of NaOCl (1%). Subsequently, the root canals will be dried with paper points, and the final irrigation procedure will be performed using NaOCl (1%) and EDTA (17%) solutions. The root canals will then be filled with gutta-percha and sealer, and the coronal restoration will be completed. Patients will be provided with a form to assess postoperative pain and asked to score it daily. The completed form will be requested after one week.	Other: Control group; root canals will irrigated with routine root canal final irrigation with NaOCl and EDTA. The teeth will be isolated with a rubber dam, and an access cavity will be created. After root canal preparation, the final irrigation procedure will be performed. Root canal treatments will be completed, and the patients' postoperative pain levels will be recorded using follow-up forms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain levels	postoperative pain levels will be describe using the visual analog scale (VAS). The VAS was classified using the following scale [15]: no pain (0); mild pain (1-3); moderate pain (4-6), and severe pain (7-10).	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dependent variables-sex	The patients' genders (female or male) will be recorded, and their relationship with postoperative pain will be statistically analyzed.	one week
dependent variable-age	The patients' ages will be recorded as numbers, and their relationship with postoperative pain will be statistically analyzed.	one week
dependent variables-teeth number	The patients' tooth numbers will be recorded, and their relationship with postoperative pain will be statistically analyzed.	one week
dependent variables-smoking habit	The patients' smoking habits will be recorded as either "yes" or "no," and their relationship with postoperative pain will be statistically analyzed.	one week

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: endodontics; postoperative pain; curcumin; photodynamic therapy; root canal irrigation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Jaw Diseases; Pain, Postoperative; Periapical Diseases; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Curcumin
• Other Study ID Numbers: 404380

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