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Completed

NCT Number: NCT05195021

The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)

Aim: The aim of this study was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis.

Methods: In total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. There were four different irrigation and disinfection groups. In group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test, Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess qualitative data. Inter-group and intra-group parameters were assessed using the Kruskal-Wallis test and Wilcoxon's test at a significance level of p < 0.05 (for both).

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Key information

Conditions

Post-operative Pain Apical Periodontitis 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)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult patients aged between 18 and 65 years
  • Moderate to severe pain (4-10) according to a visual analogue scale (VAS)
  • Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)

Exclusion criteria

  • Pregnancy or lactation
  • Taking analgesics or anti-inflammatory drugs 12 hours before the treatment
  • Taking antibiotics in the month prior to the treatment
  • Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex
  • Allergy to articaine or non-steroid anti-inflammatory drugs

Treatment and study plan

EDDY

Device

EDDY (VDW) sonic irrigation activation system

Other names: EDDY (VDW, Munich, Germany)

Diode Laser device

Device

980-nm diode laser device

Other names: Medency Primo 10 W Diode Laser, Vicenza, Italy

Conventional irrigation

Device

Conventional root canal irrigation with 31-guage side port needle

Other names: 31-guage side port needle (NaviTip; Ultradent, South Jordan, UT)

Primary outcomes

  1. Post-operative pain

    Time frame: 7 days

    Post-operative pain levels in each group were assessed by visual analog scale (VAS) The pain levels were evaluated at 8, 24, 48 hours and 7 days post-procedure

  2. Anaglesic intake

    Time frame: 7 days

    After the operation nalgesic intake and time intervals were recorded

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain in Mandibular Molars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial

Acronym: PP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2022
Registry last updated
Jan 18, 2022

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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