The Effect of Root-canal Medicaments on Post-operative Pain in Re-treatment Cases

Comparative Evaluation of the Effect of Three Different Root-canal Medicaments on Post-operative Pain in Re-treatment Cases: a Randomized Clinical Trial

This randomized clinical trial compares the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases.

Study Overview

• Status: Completed
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: root canal medicament-calcium hydroxide; Other: root canal medicament-chlorhexidine gel; Other: root canal medicament-calcuim hyroxide &chlorhexidine ge

Detailed Description

Introduction: The aim of this study was to compare the effects of intracanal medicaments on the incidence of postoperative pain and flare-up in asymptomatic retreatment cases.

Methods: One hundred twenty patients with asymptomatic teeth with single-root, single-canal without spontaneous pain or swelling were included in the present study. All patients were previously undergone endodontic treatment but still had periapical radiolucencies. Patients were randomly and equally divided into three groups in which stratified randomization was performed based on the gender and the age of the patients. Intracanal medicaments were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Calcium hydroxide (Ca(OH)2), chlorhexidine gel (CHX), calcium hydroxide, and chlorhexidine gel combinations were used as intracanal medicaments in the present study. Postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using a visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were evaluated during clinical examinations performed postoperatively after 2 and 7 days.

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• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın
    • Merkez, Aydın, Turkey
      • Hicran Dönmez Özkan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients between 20 - 65 years of ages
2. Patients who agree to participate this study
3. Not taking analgesic or antibiotics in the last week
4. Single root and single-canal incisor, canine, premolar teeth that have been treated only once before
5. Teeth with previous endodontic treatment but with insufficient root canal filling on radiographic examination
6. Teeth with periapical lesions and at least 2 years since the previous treatment, although root canal filling seems sufficient
7. Periapical radiolucency, teeth with increased or unchanged according to pre-treatment radiography (if available)
8. Teeth are asymptomatic
9. Patients who had good oral hygiene

Exclusion Criteria:

1. Pregnant patients and patients in lactation period
2. Having used corticosteroids in the last 6 months
3. Individuals with systemic diseases (endocarditis, immune system diseases,etc.) requiring antibiotic prophylaxis
4. Having received immunosuppressive therapy within the last week
5. Patients who had systemic or allergic sensitivty for the NSAIDs and local ananesthetics
6. The presence of advanced periodontal disease (probing depth > 4 mm)
7. The presence of a foreign body in the root canal that prevents entry (broken file, post, etc.)
8. Fracture or crack in the root
9. Teeth that cannot reach the working length due to calcification in the root canal and step formation
10. Teeth that cannot be restored due to excessive loss of material in the coronal structure
11. The presence of more than one adjacent tooth requiring endodontic treatment that may cause reflected pain in the same patient.
12. Teeth that develop any complications ( breakage of endodontic file, perforation, inability to determine the working length with the apex finder) during the removal of the canal filling material.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Calcium hydroxide ( Ca(OH)2 ); Root canal medicament which was placed into root canals with a lentulo spiral.	Other: root canal medicament-calcium hydroxide; Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.
Experimental: Chlorhexidine gel (CHX gel); Root canal medicament which was placed into root canals with a lentulo spiral.	Other: root canal medicament-chlorhexidine gel; Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.
Experimental: Calcium hydroxide+ CHX gel; Root canal medicament which was placed into root canals with a lentulo spiral.	Other: root canal medicament-calcuim hyroxide &chlorhexidine ge; Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level comparison after the application of three different root canal medicaments in root canal : 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.	6 th hours
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 12 th 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.	12 th hour
Pain level comparison after the application of three different root canal medicaments in root canal : 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.	24 th hour
Pain level comparison after the application of three different root canal medicaments in root canal : 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 the application of three different root canal medicaments in root canal : 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 the application of three different root canal medicaments in root canal : 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 the application of three different root canal medicaments in root canal : 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 the application of three different root canal medicaments in root canal : 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 the application of three different root canal medicaments in root canal : 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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

General Publications

• Erdem Hepsenoglu Y, Eyuboglu TF, Ozcan M. Postoperative Pain Intensity after Single- versus Two-visit Nonsurgical Endodontic Retreatment: A Randomized Clinical Trial. J Endod. 2018 Sep;44(9):1339-1346. doi: 10.1016/j.joen.2018.05.017. Epub 2018 Jul 24.
• Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): August 23, 2020

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: retreatment
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Tooth, Nonvital; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Calcium-Regulating Hormones and Agents; Disinfectants; Dental Disinfectants; Calcium; Chlorhexidine; Chlorhexidine gluconate; Root Canal Irrigants
• Other Study ID Numbers: 2019/079

Drug and device information, study documents

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