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Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases

Primary Purpose

Postoperative Pain, Root Canal Infection, Endodontic Disease

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Single-Visit Retreatment
Multiple-Visit-"Calcium Hydroxide"
Multiple-Visit-"Corticosteroid Paste"
Multiple-Visit-"Antibiotic Paste"
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Endodontics, Retreatment, Postoperative Pain, Visual Analogue Pain Scale

Eligibility Criteria

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

Inclusion Criteria:

Patients who were not included the study who;

  • were pregnant or breast feeding during the duration of the study,
  • have systemic disease,
  • have any pain and/or any facial swelling, abscess,
  • were immunocompromised,
  • were under 18 yrs. and over 65 yrs. age,
  • were taking antibiotics or corticosteroids within previous three months,
  • have multiple teeth that required retreatment at the same time period; for eliminating pain referral,
  • have root canals that could not be well-treated with orthograde retreatment.

Exclusion Criteria:

The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Single-Visit Retreatment

Multiple-Visit-"Calcium Hydroxide"

Multiple-Visit-"Corticosteroid Paste"

Multiple-Visit-"Antibiotic Paste"

Arm Description

Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.

Outcomes

Primary Outcome Measures

Change from Baseline in Postoperative Pain after Retreatment at 48 hours.
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2017
Last Updated
February 27, 2018
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03042377
Brief Title
Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases
Official Title
The Clinical Comparative Evaluation Of Postoperative Pain In Single-Visit And Multiple-Visit Pretreatment Cases: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
July 30, 2015 (Actual)
Study Completion Date
August 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
The purpose of this randomized clinical trial was to evaluate the incidence of postoperative pain after retreatment using different techniques. Patients whom need retreatment were included. The presence of postoperative pain was assessed after retreatment cases at 1, 6, 12, 24 and 48 hrs.
Detailed Description
The aim of this clinical study was to evaluate the intensity and duration of postoperative pain after single-visit and multiple-visit root canal retreatment procedures. Patients who have asymptomatic failed endodontically treated teeth were included in this study and routine channel treatment procedure will be applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Eighty asymptomatic teeth were randomly participated into four treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 1, 6, 12, 24 and 48 hrs. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the retreatments, the nature of the study, complications and associated risks were totally explained and written informed consent was obtained from all study participants. The patients were offered local anesthetic before the treatment start. The routine root canal retreatment procedure was applied. Different intracanal medicaments used between sessions in accordance to the manufacturers' instructions. At the end of retreatment, each patient was given an evaluation sheet, explained the treatment procedure and using of visual analogue pain scales, and informed to be returned during the following one week. After one week the teeth was examined according to for pain intensity, percussion & palpation sensitivity, swelling, analgesic intake and clinical status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Root Canal Infection, Endodontic Disease
Keywords
Endodontics, Retreatment, Postoperative Pain, Visual Analogue Pain Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The patients were assigned to four medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
Masking
Participant
Masking Description
The patients were unaware as to which study group they had been allocated.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single-Visit Retreatment
Arm Type
Active Comparator
Arm Description
Root canal retreatment were performed according to the guidelines for single-visit endodontic treatments.
Arm Title
Multiple-Visit-"Calcium Hydroxide"
Arm Type
Active Comparator
Arm Description
Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
Arm Title
Multiple-Visit-"Corticosteroid Paste"
Arm Type
Active Comparator
Arm Description
Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
Arm Title
Multiple-Visit-"Antibiotic Paste"
Arm Type
Active Comparator
Arm Description
Root canal retreatment were performed according to the guidelines for multiple-visit endodontic treatments.
Intervention Type
Other
Intervention Name(s)
Single-Visit Retreatment
Other Intervention Name(s)
Single-Visit Root Canal Therapy
Intervention Description
The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.
Intervention Type
Drug
Intervention Name(s)
Multiple-Visit-"Calcium Hydroxide"
Other Intervention Name(s)
Calcium Hydroxide
Intervention Description
The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.
Intervention Type
Drug
Intervention Name(s)
Multiple-Visit-"Corticosteroid Paste"
Other Intervention Name(s)
Ledermix Paste
Intervention Description
The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid & antibiotic paste and the cavity was filled with temporary restorative material.
Intervention Type
Drug
Intervention Name(s)
Multiple-Visit-"Antibiotic Paste"
Other Intervention Name(s)
Triple Antibiotic Paste
Intervention Description
The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.
Primary Outcome Measure Information:
Title
Change from Baseline in Postoperative Pain after Retreatment at 48 hours.
Description
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root retreatment influence the occurrence of postoperative pain.Postoperative pain was assessed using a well defined Heft-Parker visual analogue scale (VAS) scale. Each patient recorded the pain level on a 170-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 1, 6, 12, 24 and 48 hours after treatment.The mm marks were removed from the scale and the scale was divided into 4 categories: No pain or faint pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 54 mm and less than 144 mm. Intense pain was defined as equal to or greater than 144 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Time Frame
Baseline, 1, 6, 12, 24 and 48 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who were not included the study who; were pregnant or breast feeding during the duration of the study, have systemic disease, have any pain and/or any facial swelling, abscess, were immunocompromised, were under 18 yrs. and over 65 yrs. age, were taking antibiotics or corticosteroids within previous three months, have multiple teeth that required retreatment at the same time period; for eliminating pain referral, have root canals that could not be well-treated with orthograde retreatment. Exclusion Criteria: The patients who forgot to fill out the form and took antibiotics and/or analgesics right after the first appointment of the therapy were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keziban Olcay, DDS. PhD.
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34083
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Pain in Single-visit and Multiple-visit Retreatment Cases

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