Postoperative Pain After the Use of Different Root Canal Sealers

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919318
• Other study ID #: 2018/08
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: April 5, 2019

Study information

• Verified date: November 2019
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 5, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Root Canal Filling Sealers
Root Canal Obturation

Locations

Country	Name	City	State
Turkey	Erciyes University, Faculty of Dentistry	Kayseri	Iç Anadolu

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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