Effect of Different Obturation Techniques on Postoperative Pain

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

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))

Study Overview

• Status: Completed
• Conditions: Pain; Pain, Postoperative; Endodontic Inflammation
• Intervention / Treatment: Other: Root Canal Obturation Technique

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Hicran Dönmez Özkan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participants between 18 - 72 years of ages,

2 Good oral hygiene,

3. Have not taken any analgesic in the last 7 days,

4. Have not taken any antibiotics in the last 7 days,

5. Positive response to both cold test (EndoIce; Coltene/Whaledent Inc, Cuyahoga ),

6. Patients diagnosed with asymptomatic irreversible pulpitis with his/her single-rooted teeth caused by a deep carious lesion,

7. 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.

9. The periapical region was healthy in radiographic diagnosis.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Ah plus; The root canals obturated with Ah plus root canal sealer (Dentsply, Sirona) and gutta-percha cones with cold lateral condensation technique.	Other: Root Canal Obturation Technique; 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
OTHER: ROEKO GuttaFlow® 2; The root canals obturated with GuttaFlow 2 root canal sealer (Coltene,Whaledent) and single tapered gutta-percha cone with cold free flow compaction technique.	Other: Root Canal Obturation Technique; 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
OTHER: GuttaCore Obturators; The root canals obturated with GuttaCore obturators (Dentsply,Sirona) and Ah plus root canal sealer with thermoplasticized solid-core carrier technique	Other: Root Canal Obturation Technique; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level comparison after root canal obturation with three different obturation technique:: 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 obturation technique.: VAS (Visual Analogue Scale) at 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.	12th hours.
Pain level comparison after root canal obturation with three different obturation technique.: 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 obturation technique.: VAS (Visual Analogue Scale) at 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.	2nd days
Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 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.	3th days
Pain level comparison after root canal obturation with three different obturation technique.: 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 obturation technique.: 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 obturation technique.: 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 obturation technique.: 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 obturation technique 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 obturation technique 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 obturation technique 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 obturation technique at 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"	2nd days
Analgesic intake comparison after root canal obturation with three different obturation technique at 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"	3th days
Analgesic intake comparison after root canal obturation with three different obturation technique 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"	4 th days
Analgesic intake comparison after root canal obturation with three different obturation technique 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 obturation technique 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 obturation technique 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: Aydin Adnan Menderes University
• Investigators: Study Director: Hicran Dönmez Özkan, Adnan Menderes 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.
• Alonso-Ezpeleta LO, Gasco-Garcia C, Castellanos-Cosano L, Martin-Gonzalez J, Lopez-Frias FJ, Segura-Egea JJ. Postoperative pain after one-visit root-canal treatment on teeth with vital pulps: comparison of three different obturation techniques. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e721-7. doi: 10.4317/medoral.17898.
• Su Y, Wang C, Ye L. Healing rate and post-obturation pain of single- versus multiple-visit endodontic treatment for infected root canals: a systematic review. J Endod. 2011 Feb;37(2):125-32. doi: 10.1016/j.joen.2010.09.005. Epub 2010 Nov 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 31, 2017
• Primary Completion (ACTUAL): March 4, 2019
• Study Completion (ACTUAL): August 15, 2019

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Pain; cold lateral condensation; GuttaCore; GuttaFlow 2; Obturation Techniques
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Inflammation; Pulpitis
• Other Study ID Numbers: ADÜDHF 2017/021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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