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Completed

NCT Number: NCT03919318

Postoperative Pain After the Use of Different Root Canal Sealers

This study evaluated the postoperative pain after the endodontic treatment using AH Plus, Endoseal MTA and EndoSequence BC sealers in root canal obturation.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University, Faculty of Dentistry

Kayseri, İç Anadolu, 38039, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants between 18 - 60 years of age,
  • Good oral hygiene,
  • Have not taken any analgesics in the last day,
  • Have not taken antibiotics in the last week,
  • Patients diagnosed with asymptomatic irreversible pulpitis caused by deep carious lesion on the mandibular first or second molar teeth.
  • A prolonged positive response to cold vitality tests,
  • The presence of pulp, which is exposed during caries removing and bleeding with a dense and thick consistency.
  • The periapical region was healthy in radiographic diagnosis.

Exclusion criteria

  • Devital teeth that have no response to pulp test,
  • The presence of advanced periodontal disease,
  • Having a systemic disease that requires antibiotic prophylaxis,
  • Radiographically more than 30° root inclination, presence of clear apex, presence of calcification, presence of root resorption,
  • The need for root canal treatment which is mesial and/or distal neighbour of the tooth to be treated,
  • The presence of a sinus tract in the relevant tooth region,
  • Having systemic diseases that reduce immune system resistance,
  • Participants with allergic sensitivity to materials and agents that should be used during the root canal treatment,
  • Allergic sensitivity to local anesthetics,
  • Pregnant participants or participants in the lactation period,
  • Over preparation or over filling during treatment,
  • Teeth which cannot be applied a rubber-dam,
  • Teeth which was damaged enough to require coronal fiber post application,
  • Sensitive to Ibuprofen based analgesics.

Treatment and study plan

Root Canal Filling Sealers

Other

Root Canal Obturation

Primary outcomes

  1. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 6th hours.

    Time frame: 6th hours

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  2. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 12th hours.

    Time frame: 12th hours

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  3. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 24th hours.

    Time frame: 24th hours

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  4. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 48th hours.

    Time frame: 48th hours

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  5. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 3rd days.

    Time frame: 3rd days

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  6. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 4th days.

    Time frame: 4th days

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  7. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 5th days.

    Time frame: 5th days

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  8. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 6th days.

    Time frame: 6th days

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

  9. Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 7th days.

    Time frame: 7th days

    Based on the VAS (Visual Analogue Scale), the pain levels of the patients were assessed. The scale consisted of a 100-mm-long line divided into 10 equal intervals from 0 (no pain) to 100 (very severe pain). Every patient was asked to mark his or her perceived postoperative pain level on the line.

Secondary outcomes

  1. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 6th hours.

    Time frame: 6th hours

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  2. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 12th hours.

    Time frame: 12th hours

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  3. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 24th hours.

    Time frame: 24th hours

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  4. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 48th hours.

    Time frame: 48th hours

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  5. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 3rd days.

    Time frame: 3rd days

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  6. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 4th days.

    Time frame: 4th days

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  7. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 5th days.

    Time frame: 5th days

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  8. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 6th days.

    Time frame: 6th days

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

  9. Analgesic intake comparison after root canal obturation with three different endodontic sealers at 7th days.

    Time frame: 7th days

    The patients were asked to choose one of the three 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: Daily activities Unbearable pain that cannot be controlled by the use of analgesics"

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Effect of Two Different Calcium Silicate Based and One Epoxy Resin-based Root Canal Sealers on Postoperative Pain After Root Canal Treatments

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Dec 3, 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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