Effect of Different Obturation Techniques on Postoperative Pain

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Completed
CT.gov ID
NCT04228913
Collaborator
(none)
90
1
3
23.5
3.8

Study Details

Study Description

Brief 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))

Condition or Disease Intervention/Treatment Phase
  • Other: Root Canal Obturation Technique
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single (Participant)Single (Participant)
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Comparison of Postoperative Pain Intensity After Three Different Obturation Techniques: A Randomized Clinical Trial
Actual Study Start Date :
Aug 31, 2017
Actual Primary Completion Date :
Mar 4, 2019
Actual Study Completion Date :
Aug 15, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pain level comparison after root canal obturation with three different obturation technique:: VAS (Visual Analogue Scale) at 6th hours. [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 obturation technique.: VAS (Visual Analogue Scale) at 12th hours. [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.

  3. Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 24th hours [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 obturation technique.: VAS (Visual Analogue Scale) at 2nd days. [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.

  5. Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 3th days. [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.

  6. Pain level comparison after root canal obturation with three different obturation technique.: VAS (Visual Analogue Scale) at 4th days. [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 obturation technique.: VAS (Visual Analogue Scale) at 5th days. [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 obturation technique.: VAS (Visual Analogue Scale) at 6th days. [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 obturation technique.: VAS (Visual Analogue Scale) at 7th days. [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 obturation technique at 6th hours [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 obturation technique at 12th hours [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 obturation technique at 24th hours [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 obturation technique at 2nd days [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"

  5. Analgesic intake comparison after root canal obturation with three different obturation technique at 3th days [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"

  6. Analgesic intake comparison after root canal obturation with three different obturation technique at 4th days [4 th 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 obturation technique at 5th days [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 obturation technique at 6th days [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 obturation technique at 7th days [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

Criteria

Ages Eligible for Study:
18 Years to 72 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Participants between 18 - 72 years of ages,

2 Good oral hygiene,

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

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

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

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

  5. 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.

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hicran Dönmez Özkan Aydın Turkey 09100

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

  • Study Director: Hicran Dönmez Özkan, Adnan Menderes University, Faculty of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hicran Dönmez Özkan, Assistant Professor, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT04228913
Other Study ID Numbers:
  • ADÜDHF 2017/021
First Posted:
Jan 14, 2020
Last Update Posted:
Jan 14, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hicran Dönmez Özkan, Assistant Professor, Aydin Adnan Menderes University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2020