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Completed

NCT Number: NCT03708081

Comparative Evaluation of Different File Systems in Postoperative Pain

Postoperative pain is a frequent complication associated with root canal treatment. The apical extrusion of irrigant and debris, including bacteria and necrotic tissue, may lead to postoperative pain, periapical inflammation, and flare-ups. The instrumentation technique and the file design may affect the amount of debris extrusion.

The aim of this study was to evaluate the influence of instrumentation techniques on the incidence and intensity of postoperative pain after single-visit root canal treatment.

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Key information

Conditions

Pulpitis Dental Pulp Diseases Dental Pulp Necrosis Jaw Diseases Mouth Diseases Necrosis Necrotic Pulp Pathologic Processes Pathological Conditions, Signs and Symptoms Periapical Diseases Periapical Periodontitis Periodontal Diseases Periodontitis Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Bülent Ecevit University, Faculty of Dentistry

Zonguldak, Turkey (Türkiye)

About this study

Sixty patients having root canal treatment indication and a single root canal were included in the study. The patients were randomly assigned into 2 groups according to root canal instrumentation technique used. In group 1; ProTaper Next (Dentsply Maillefer, Ballaigues, Switzerland) instruments with rotational motion, in group 2 TF Adaptive (SybronEndo, Orange, CA) instruments with adaptive motion were used for root canal treatments. Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed via a four-point pain intensity scale. All the participants were called through the phone at 12, 24 and 48h to obtain the pain scores. Data were analyzed using the Mann Whitney-U, Friedman and Wilcoxon tests.

Who can participate

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

Inclusion criteria

  • having root canal treatment indication
  • single root canal

Exclusion criteria

  • previously treated tooth

Treatment and study plan

ProTaper Next

Procedure

Root canal instrument

TF Adaptive

Procedure

Root canal instrument

Primary outcomes

  1. Post operative pain

    Time frame: 2 days

    Postoperative pain which occurs after root canal instrumentation and measured with a commonly used scale named 'four-point pain intensity scale' for pain intensity. Patients were instructed postoperatively to express their pain according to the staed scale ranging between no pain and severe pain.

    The scale consists of 4 scores ranging between 1-4. The pain categories were as follows;

    • no pain;
    • mild pain (slight discomfort, no need for treatment);
    • moderate pain (pain relieved by medication);
    • severe pain (pain and/or swelling not relieved by simple analgesic medication and unscheduled visit required). For patients having no pain score 1, for patients having slight pain in case of no medication score 2 , and score 3 in case of any requirement of medication due to moderate pain, and score 4 for patients having severe pain with the requirement of an unscheduled visit were accepted.

    The higher values represent more pain intensity.

Sponsors and collaborators

Lead sponsor

Bulent Ecevit University

Other

Registry information

Official study title

Comparative Evaluation of Different File Systems in Postoperative Pain: Randomize Clinical Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2018
Registry last updated
Dec 20, 2018

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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