Post-operative Pain After Different Irrigation and Disinfection Methods in Single-rooted Teeth

NCT07170098 | Completed

• 1 other identifier: BİRUNİ-BAP-01-2023-01-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aimed to evaluate post-operative pain (PP) in single-rooted teeth with asymptomatic apical periodontitis following final irrigation with sonic activation systems (EDDY and EndoActivator), with and without adjunctive 980-nm diode laser disinfection. Eighty patients were randomized into four groups: Group 1 (EDDY), Group 2 (EndoActivator), Group 3 (EDDY + laser), and Group 4 (EndoActivator + laser). PP intensity and analgesic intake were recorded at 8, 24, 48 hours, and on day 7. The study found no significant differences in PP or analgesic use among the groups, indicating that laser-assisted or different sonic activation methods did not reduce post-operative pain.

Conditions

Post Operative Pain; Apical Periodontitis; Asymptomatic Infections

Keywords

Asymptomatic apical periodontitis; Diode laser; EDDY; EndoActivator; Post-operative pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain intensity

  Pain intensity was self-reported by patients using a numerical rating scale (0-10), where 0 indicates no pain and 10 indicates the worst possible pain.

  8, 24, and 48 hours, and 7 days after the endodontic procedure

Secondary Outcomes (1)

• Analgesic consumption

  8, 24, and 48 hours, and 7 days after the endodontic procedure

Study Arms (4)

EDDY sonic irrigation

EXPERIMENTAL

Final irrigation activation was performed using the EDDY sonic system with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied.

Device: EDDY sonic irrigation system

EndoActivator (EA) sonic irrigation

EXPERIMENTAL

Final irrigation activation was performed using the EndoActivator (EA) medium tip with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied.

Device: EndoActivator (EA) sonic irrigation system

EDDY sonic irrigation + 980-nm diode laser

EXPERIMENTAL

Final irrigation activation was performed using the EDDY sonic system as in Arm 1, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode).

Device: EDDY sonic irrigation system; Device: 980-nm diode laser

EndoActivator (EA) sonic irrigation + 980-nm diode laser

EXPERIMENTAL

Final irrigation activation was performed using the EndoActivator (EA) system as in Arm 2, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode).

Device: EndoActivator (EA) sonic irrigation system; Device: 980-nm diode laser

Interventions

EDDY sonic irrigation system DEVICE

Sonic activation of irrigating solutions during endodontic treatment.

EDDY sonic irrigation; EDDY sonic irrigation + 980-nm diode laser

EndoActivator (EA) sonic irrigation system DEVICE

Sonic activation of irrigating solutions during endodontic treatment.

EndoActivator (EA) sonic irrigation; EndoActivator (EA) sonic irrigation + 980-nm diode laser

980-nm diode laser DEVICE

Diode laser irradiation during endodontic treatment.

EDDY sonic irrigation + 980-nm diode laser; EndoActivator (EA) sonic irrigation + 980-nm diode laser

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically healthy adult patients aged 18-65 years
• Patients diagnosed with asymptomatic apical periodontitis in permanent single-rooted teeth with closed apices and radiographic PAI score of 3 or 4
• Healthy periodontal conditions

You may not qualify if:

• Pregnant women
• Patients with systemic disorders
• Teeth with open apex, prosthetic restorations, mobility \> grade I, periodontal pocket depth \> 4 mm, non-restorable condition, calcified root canals, resorption, traumatic occlusion, or history of previous endodontic treatment
• Patients who had taken analgesics within 12 hours prior to intervention
• Patients who had received antibiotic therapy within the past month

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis; Asymptomatic Infections

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Infections; Asymptomatic Diseases; Disease Attributes

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were blinded to the irrigation and disinfection method. The operator was not blinded due to the nature of the interventions. Post-operative pain was self-reported by patients using numerical rating scales and outcomes assesor was was not blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel-group randomized controlled trial

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start: August 10, 2025
• Primary Completion: August 11, 2025
• Study Completion: October 31, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)