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

Post-operative Pain Following Different Irrigation Activation and Disinfection Approaches in Single-rooted Teeth With Asymptomatic Apical Periodontitis: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07170098
Enrollment
80
Registered
2025-09-12
Start date
2025-08-10
Completion date
2025-10-31
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Asymptomatic Infections, Post Operative Pain

Keywords

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

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.

Detailed description

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.

Interventions

DEVICEEDDY sonic irrigation system

Sonic activation of irrigating solutions during endodontic treatment.

DEVICEEndoActivator (EA) sonic irrigation system

Sonic activation of irrigating solutions during endodontic treatment.

DEVICE980-nm diode laser

Diode laser irradiation during endodontic treatment.

Sponsors

Biruni University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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.

Intervention model description

Parallel-group randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain intensity8, 24, and 48 hours, and 7 days after the endodontic procedurePain 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.

Secondary

MeasureTime frameDescription
Analgesic consumption8, 24, and 48 hours, and 7 days after the endodontic procedurePatients recorded the type, dosage, and timing of analgesics taken during the postoperative period.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026