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Completed

NCT Number: NCT04197531

Postoperative Pain After the Use of Different Last Irrigation Method During Root Canal Treatment in Primary Teeth

This study was to evaluate and compare the postoperative pain levels after using EndoActivator and conventional endodontic syringe irrigation in root canal therapy of primary molars.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University, Faculty of Dentistry

Kayseri, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients exhibiting positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the Frankl's scale)
  • American Society of Anesthesiologists class 1 patients aged 5-9 years
  • Patients with symptomatic irreversible pulpitis of maxillary primary molars confirmed using periapical radiographs, percussion, and cold test
  • Patients having teeth with two-thirds of each root remaining
  • Absence of periapical lesions and interradicular radiolucency
  • Moderate to very severe (2-4) five-face scale pain scores in the 24-hour period before the procedure.

Exclusion criteria

  • Patients who had taken analgesics and antibiotics within the last 12 hours before root canal treatment
  • Teeth with pathologic root resorption
  • Teeth with excessive mobility.

Treatment and study plan

Irrigation Method

Other

Irrigation Method

Primary outcomes

  1. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 8th hours

    Time frame: 8th hours

    Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

  2. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 24th hours

    Time frame: 24th hours

    Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

  3. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 48th hours

    Time frame: 48th hours

    Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

  4. Pain level comparison after root canal treatment with two different irrigation methods:The five-face pain scale chart at 72th hours

    Time frame: 72th hours

    Pain levels according to the five-face scale were recorded numerically as no pain (0), mild pain (1), moderate pain (2), severe pain (3), or very severe pain (4). All participants and their parents were informed by a blind researcher about filling out the five-face pain scale chart. To achieve standardization, pain levels were recorded by the participants under the same parent's guidance at each time interval.

Secondary outcomes

  1. Analgesic intake comparison after root canal treatment with two different irrigation methods at 0-8 hours.

    Time frame: 0-8 hours

    The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".

  2. Analgesic intake comparison after root canal treatment with two different irrigation methods at 8-24 hours.

    Time frame: 8-24 hours

    The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".

  3. Analgesic intake comparison after root canal treatment with two different irrigation methods at 24-48 hours.

    Time frame: 24-48 hours

    The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".

  4. Analgesic intake comparison after root canal treatment with two different irrigation methods at 48-72 hours.

    Time frame: 48-72 hours

    The patients were asked to choose one of the two options: "0: No pain, or no pain which does not require the use of analgesics", "1: Moderate pain which can be controlled very well by the use of analgesics and does not affect daily activities or sleep".

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

A Comparative Evaluation of the Effect of EndoActivator and Endodontic Syringe Usage on Postoperative Pain in Root Canal Irrigations in Primary Molar Teeth: A Randomized Clinical Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2019
Registry last updated
Dec 17, 2019

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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