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Completed

NCT Number: NCT04228913

Effect of Different Obturation Techniques on Postoperative Pain

This study evaluated the postoperative pain after the endodontic treatment by using three different obturation techniques. ( Cold lateral condensation (CLC), thermoplasticized solid-core carrier method (GuttaCore) and cold free-flow compation tecnique ( GuttaFlow2))

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Key information

Conditions

Pain, Postoperative Dental Pulp Diseases Endodontic Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Pulpitis Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hicran Dönmez Özkan

Aydin, 09100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants between 18 - 72 years of ages,

2 Good oral hygiene,

  • Have not taken any analgesic in the last 7 days,
  • Have not taken any antibiotics in the last 7 days,
  • Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),
  • Patients diagnosed with asymptomatic irreversible pulpitis with his/her single-rooted teeth caused by a deep carious lesion,
  • Patients have single-rooted teeth requiring endodontic treatment according to the pre-prosthetic reason,

8.The presence of profusely pulp bleeding with a thick consistency, which is exposed during caries removing.

  • The periapical region was healthy in radiographic diagnosis.

Exclusion criteria

  • Patients who refuse to participate in this study,
  • Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications),
  • Devital teeth that have no response to pulp test,
  • The presence of advanced periodontal disease (probing depth > 4 mm),
  • The presence of open apex,
  • The presence of calcification,
  • The presence of resorption,
  • Patients who had multiple teeth requiring endodontic treatment,
  • Patients with allergic sensitivity to materials and agents that should be used during the root canal treatment,
  • Allergic sensitivity to local anesthetics,
  • Patients who had systemic or allergic sensitivity for the NSAIDs,
  • Pregnant participants or participants in the lactation period,
  • Teeth cannot be applied to a rubber-dam.

Treatment and study plan

Root Canal Obturation Technique

Other

This study aims to compare the effects of three different obturation techniques(cold lateral condensation,thermoplasticized solid-core carrier method, cold free flow compaction technique) on postoperative pain following the endodontic therapy

Primary outcomes

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

    Time frame: 12th hours.

    ased 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 obturation technique.: 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 obturation technique.: VAS (Visual Analogue Scale) at 2nd days.

    Time frame: 2nd 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.

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

    Time frame: 3th 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 obturation technique.: 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 obturation technique.: 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 obturation technique.: 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 obturation technique.: 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 obturation technique 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 obturation technique 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 obturation technique 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 obturation technique at 2nd days

    Time frame: 2nd 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"

  5. Analgesic intake comparison after root canal obturation with three different obturation technique at 3th days

    Time frame: 3th 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 obturation technique at 4th days

    Time frame: 4 th 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 obturation technique 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 obturation technique 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 obturation technique 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

Aydin Adnan Menderes University

Other

Registry information

Official study title

Comparison of Postoperative Pain Intensity After Three Different Obturation Techniques: A Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2020
Registry last updated
Jan 14, 2020

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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