Effect of Different Obturation Techniques on Postoperative Pain

Study Overview
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Brief Summary
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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))

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

Conditions
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Pain, Postoperative, Pain, Endodontic Inflammation

Intervention / Treatment
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* Other: Root Canal Obturation Technique


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single (Participant)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ah plus<br>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<br>* 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<br>|
| Other: ROEKO GuttaFlow® 2<br>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<br>* 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<br>|
| Other: GuttaCore Obturators<br>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<br>* 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<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cold lateral condensation, Postoperative Pain, GuttaCore, GuttaFlow 2, Obturation Techniques