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NCT Number: NCT07170098

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, 34010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDDY sonic irrigation system

Device

Sonic activation of irrigating solutions during endodontic treatment.

EndoActivator (EA) sonic irrigation system

Device

Sonic activation of irrigating solutions during endodontic treatment.

980-nm diode laser

Device

Diode laser irradiation during endodontic treatment.

Primary outcomes

  1. Post-operative pain intensity

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

    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.

Secondary outcomes

  1. Analgesic consumption

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

    Patients recorded the type, dosage, and timing of analgesics taken during the postoperative period.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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