Postoperative Pain in Photodynamic Therapy Using Curcumin As a Photosensitizer

December 28, 2024 updated by: Meltem Sümbüllü, Ataturk University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25240
        • Ataturk University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
postoperative pain levels
Time Frame: one week
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
dependent variables-sex
Time Frame: one week
The patients' genders (female or male) will be recorded, and their relationship with postoperative pain will be statistically analyzed.
one week
dependent variable-age
Time Frame: one week
The patients' ages will be recorded as numbers, and their relationship with postoperative pain will be statistically analyzed.
one week
dependent variables-teeth number
Time Frame: one week
The patients' tooth numbers will be recorded, and their relationship with postoperative pain will be statistically analyzed.
one week
dependent variables-smoking habit
Time Frame: one week
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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