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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Postoperative Pain After the Use of Different Root Canal Sealers

Clinicaltrials.gov identifier NCT03919318

Recruitment Status Completed

First Posted April 18, 2019

Last update posted December 3, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Postoperative Pain
  • Intervention/Treatment: Other: Root Canal Filling Sealers
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: Effect of Two Different Calcium Silicate Based and One Epoxy Resin-based Root Canal Sealers on Postoperative Pain After Root Canal Treatments
  • Actual Study Start Date: April 2018
  • Actual Primary Completion Date: April 2019
  • Actual Study Completion Date: April 2019
Arms and interventions
Arm Intervention/treatment
Experimental: AH-Plus
Other: Root Canal Filling Sealers
Root Canal Obturation
Experimental: EndoSeal MTA
Other: Root Canal Filling Sealers
Root Canal Obturation
Experimental: Endosequence BC Sealer
Other: Root Canal Filling Sealers
Root Canal Obturation
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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"
Eligibility Criteria
  • Ages Eligible for Study: 18 to 60 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts
Locations

Turkey, İç Anadolu
Erciyes University, Faculty of Dentistry
Kayseri

Sponsors and Collaborators

TC Erciyes University

Investigators

Study Director: Tuğrul Aslan, PHD. Dr. Erciyes University, Faculty of Dentistry

More Information