Postoperative Pain After the Use of Different Root Canal Sealers

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Root Canal Filling Sealers

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İç Anadolu
    • Kayseri, İç Anadolu, Turkey, 38039
      • Erciyes University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	6th hours
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	12th hours
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	24th hours
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	48th hours
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	3rd days
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	4th days
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	5th days
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	6th days
Pain level comparison after root canal obturation with three different endodontic sealers: VAS (Visual Analogue Scale) at 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.	7th days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	6th hours
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	12th hours
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	24th hours
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	48th hours
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	3rd days
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	4th days
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	5th days
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	6th days
Analgesic intake comparison after root canal obturation with three different endodontic sealers at 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"	7th days

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: Tuğrul Aslan, PHD. Dr., Erciyes University, Faculty of Dentistry

Publications and helpful links

General Publications

• Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
• Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): April 5, 2019

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 30, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain; endodontic treatment; Root canal filling; Endoseal MTA; Endosequence BC; AH Plus
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2018/08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No