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

NCT ID: NCT07170098

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-10

Study Completion Date

2025-10-31

Brief Summary

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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.

Detailed Description

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Post-operative pain (PP) is a common concern following root canal treatment, influenced by mechanical, chemical, and microbial factors. Effective irrigation and disinfection are crucial to remove debris and microorganisms from complex canal systems. This study investigated the effects of two sonic irrigation activation systems, EDDY and EndoActivator (EA), with and without 980-nm diode laser disinfection, on PP in patients with single-rooted teeth diagnosed with asymptomatic apical periodontitis.

Eighty medically healthy adult patients (18-65 years) were randomly assigned to four groups. Group 1 underwent final irrigation with EDDY; Group 2 with EA; Group 3 with EDDY followed by laser irradiation; Group 4 with EA followed by laser irradiation. All procedures were completed in a single visit. PP was measured using a 0-10 numerical rating scale at 8, 24, 48 hours, and day 7. Analgesic consumption was also recorded.

Statistical analysis showed no significant differences among groups for age, sex, PP scores, or analgesic intake. None of the patients experienced severe pain or swelling requiring emergency intervention. The findings suggest that both EDDY and EA sonic irrigation systems, with or without adjunctive 980-nm diode laser disinfection, do not significantly affect post-operative pain or analgesic use following single-visit root canal treatment of asymptomatic apical periodontitis.

These results provide insight into the effectiveness of sonic irrigation activation and laser disinfection in routine endodontic practice, indicating that alternative techniques may be explored to optimize patient comfort and treatment outcomes.

Conditions

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Post Operative Pain Apical Periodontitis Asymptomatic Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel-group randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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EDDY sonic irrigation

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.

Group Type EXPERIMENTAL

EDDY sonic irrigation system

Intervention Type DEVICE

Sonic activation of irrigating solutions during endodontic treatment.

EndoActivator (EA) sonic irrigation

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.

Group Type EXPERIMENTAL

EndoActivator (EA) sonic irrigation system

Intervention Type DEVICE

Sonic activation of irrigating solutions during endodontic treatment.

EDDY sonic irrigation + 980-nm diode laser

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).

Group Type EXPERIMENTAL

EDDY sonic irrigation system

Intervention Type DEVICE

Sonic activation of irrigating solutions during endodontic treatment.

980-nm diode laser

Intervention Type DEVICE

Diode laser irradiation during endodontic treatment.

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

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).

Group Type EXPERIMENTAL

EndoActivator (EA) sonic irrigation system

Intervention Type DEVICE

Sonic activation of irrigating solutions during endodontic treatment.

980-nm diode laser

Intervention Type DEVICE

Diode laser irradiation during endodontic treatment.

Interventions

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EDDY sonic irrigation system

Sonic activation of irrigating solutions during endodontic treatment.

Intervention Type DEVICE

EndoActivator (EA) sonic irrigation system

Sonic activation of irrigating solutions during endodontic treatment.

Intervention Type DEVICE

980-nm diode laser

Diode laser irradiation during endodontic treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Sema Sönmez Kaplan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BİRUNİ-BAP-01-2023-01-05

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BİRUNİ-BAP-01-2023-01-05

Identifier Type: -

Identifier Source: org_study_id

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