Effect of Different Obturation Techniques on Postoperative Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228913
• Other study ID #: ADÜDHF 2017/021
• Status: Completed
• Phase: Phase 4
• Start date: August 31, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: January 2020
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 15, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endodontic Inflammation
• Inflammation
• Pain
• Pain, Postoperative
• Pulpitis

Intervention

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

Locations

Country	Name	City	State
Turkey	Hicran Dönmez Özkan	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alonso-Ezpeleta LO, Gasco-Garcia C, Castellanos-Cosano L, Martín-González J, López-Frías 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. — 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. E — View Citation

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. Review. — View Citation

Outcome

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