Postoperative Pain in Photodynamic Therapy Using Curcumin As a Photosensitizer

NCT06752655 | Not Yet Recruiting

• 1 other identifier: 404380
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periapical Diseases; Postoperative Dental Pain; Irrigation Solution; Photodynamic Therapy (PDT)

Keywords

postoperative pain; endodontics; root canal irrigation; curcumin; photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• dependent variables-sex

  one week

• dependent variable-age

  one week

• dependent variables-teeth number

  one week

• dependent variables-smoking habit

  one week

Study Arms (2)

Curcumin with photodynamic therapy

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Interventions

Curcumin with photodynamic thearpy OTHER

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.

Curcumin with photodynamic therapy

Control group OTHER

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.

control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University

Erzurum, yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Diseases; Pain, Postoperative

Interventions

Curcumin; Control Groups

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Meltem Sumbullu, DDS

CONTACT

+90 442 231 1111; meltem_endo@hotmail.com

Tuğçe Sönmez, DDS

CONTACT

+90 442 236 0942; dishek@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)