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

Primary Purpose

Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
root canal medicament-calcium hydroxide
root canal medicament-chlorhexidine gel
root canal medicament-calcuim hyroxide &chlorhexidine ge
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring retreatment

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hicran Dönmez Özkan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Calcium hydroxide ( Ca(OH)2 )

Chlorhexidine gel (CHX gel)

Calcium hydroxide+ CHX gel

Arm Description

Root canal medicament which was placed into root canals with a lentulo spiral.

Root canal medicament which was placed into root canals with a lentulo spiral.

Root canal medicament which was placed into root canals with a lentulo spiral.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2021
Last Updated
September 12, 2021
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT05052814
Brief Title
The Effect of Root-canal Medicaments on Post-operative Pain in Re-treatment Cases
Official Title
Comparative Evaluation of the Effect of Three Different Root-canal Medicaments on Post-operative Pain in Re-treatment Cases: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2019 (Actual)
Primary Completion Date
June 23, 2020 (Actual)
Study Completion Date
August 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
retreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calcium hydroxide ( Ca(OH)2 )
Arm Type
Experimental
Arm Description
Root canal medicament which was placed into root canals with a lentulo spiral.
Arm Title
Chlorhexidine gel (CHX gel)
Arm Type
Experimental
Arm Description
Root canal medicament which was placed into root canals with a lentulo spiral.
Arm Title
Calcium hydroxide+ CHX gel
Arm Type
Experimental
Arm Description
Root canal medicament which was placed into root canals with a lentulo spiral.
Intervention Type
Other
Intervention Name(s)
root canal medicament-calcium hydroxide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
root canal medicament-chlorhexidine gel
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
root canal medicament-calcuim hyroxide &chlorhexidine ge
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th hours.
Description
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.
Time Frame
6 th hours
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 12 th hours.
Description
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.
Time Frame
12 th hour
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 24th hours.
Description
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.
Time Frame
24 th hour
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 2nd days.
Description
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.
Time Frame
2nd days
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 3th days.
Description
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.
Time Frame
3th days
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 4th days.
Description
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.
Time Frame
4th days
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 5th days.
Description
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.
Time Frame
5th days
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 6th days.
Description
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.
Time Frame
6th days
Title
Pain level comparison after the application of three different root canal medicaments in root canal : VAS (Visual Analogue Scale) at 7th days.
Description
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.
Time Frame
7th days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients between 20 - 65 years of ages Patients who agree to participate this study Not taking analgesic or antibiotics in the last week Single root and single-canal incisor, canine, premolar teeth that have been treated only once before Teeth with previous endodontic treatment but with insufficient root canal filling on radiographic examination Teeth with periapical lesions and at least 2 years since the previous treatment, although root canal filling seems sufficient Periapical radiolucency, teeth with increased or unchanged according to pre-treatment radiography (if available) Teeth are asymptomatic Patients who had good oral hygiene Exclusion Criteria: Pregnant patients and patients in lactation period Having used corticosteroids in the last 6 months Individuals with systemic diseases (endocarditis, immune system diseases,etc.) requiring antibiotic prophylaxis Having received immunosuppressive therapy within the last week Patients who had systemic or allergic sensitivty for the NSAIDs and local ananesthetics The presence of advanced periodontal disease (probing depth > 4 mm) The presence of a foreign body in the root canal that prevents entry (broken file, post, etc.) Fracture or crack in the root Teeth that cannot reach the working length due to calcification in the root canal and step formation Teeth that cannot be restored due to excessive loss of material in the coronal structure The presence of more than one adjacent tooth requiring endodontic treatment that may cause reflected pain in the same patient. 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.
Facility Information:
Facility Name
Hicran Dönmez Özkan
City
Merkez
State/Province
Aydın
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30054099
Citation
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.
Results Reference
background
PubMed Identifier
20647083
Citation
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.
Results Reference
background

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

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