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Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth

Primary Purpose

Postoperative Pain, Endodontically Treated Teeth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EDTA and CHX Solution
EDTA Solution
CHX Solution
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, Postoperative Pain, Visual Analogue Pain Scale

Eligibility Criteria

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

Inclusion Criteria:

-Patients who were healthy volunteers and who have devital premolar and molar teeth with PAI 3-5score requiring root canal treatment for first time.

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 days,
  • have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral,
  • have root canals that could not be well-treated with orthograde root canal treatment.

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 Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

EDTA and CHX solution

EDTA solution

CHX solution

Arm Description

Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA and CHX solution.

Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA solution.

Root canal irrigation was performed according to the guidelines to the manufacturers instructions for CHX solution.

Outcomes

Primary Outcome Measures

Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week.
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root canal treatment 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 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS 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 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.

Secondary Outcome Measures

Full Information

First Posted
March 13, 2020
Last Updated
April 3, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04310254
Brief Title
Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth
Official Title
The Clinical Comparative Evaluation of Different Final Irrigation Protocols on Postoperative Endodontic Pain In Devital Teeth: A Prospective Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 root canal treatment using different final irrigation protocols. Patients whom need root canal treatment for first time were included. The presence of postoperative pain was assessed after root canal treatment cases at 12, 24, 48, 72 hrs and 1 week.
Detailed Description
The aim of this clinical study was to evaluate the intensity and duration of postoperative pain following different final irrigation procedures. Patients who have asymptomaticdevital teeth required endodontic treatment were included in this study and routine root canal treatment procedure was applied to these teeth. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Ninety asymptomatic teeth were randomly participated into 3 treatment groups in terms of intracanal medicament applied. The presence of postoperative pain was assessed after 12, 24, 48, 72 hrs and 1 week. Postoperative pain was recorded by each patient by using visual analogue pain scale. Before the treatments, 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 treatment procedure was applied. Different final irrigation solutions applied in accordance to the manufacturers' instructions. At the end of treatment, 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, Endodontically Treated Teeth
Keywords
Endodontics, Postoperative Pain, Visual Analogue Pain Scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment The patients were assigned to 3 medication groups randomly with an equal allocation rate between groups.The patients in the groups had same characteristics.
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant and Outcomes Assessor) The patients were unaware as to which study group they had been allocated.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EDTA and CHX solution
Arm Type
Active Comparator
Arm Description
Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA and CHX solution.
Arm Title
EDTA solution
Arm Type
Active Comparator
Arm Description
Root canal irrigation was performed according to the guidelines to the manufacturers instructions for EDTA solution.
Arm Title
CHX solution
Arm Type
Active Comparator
Arm Description
Root canal irrigation was performed according to the guidelines to the manufacturers instructions for CHX solution.
Intervention Type
Procedure
Intervention Name(s)
EDTA and CHX Solution
Intervention Description
The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with Qmix 2in1 solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
Intervention Type
Procedure
Intervention Name(s)
EDTA Solution
Intervention Description
The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with EDTA solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
Intervention Type
Procedure
Intervention Name(s)
CHX Solution
Intervention Description
The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with CHX solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
Primary Outcome Measure Information:
Title
Change from Baseline in Postoperative Pain after Root Cana Treatment at 1 week.
Description
The primary outcome measure of the study was to assess if different intracanal medicaments and single-visit root canal treatment 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 100-mm VAS scale experimental basis for revising the graphic rating scale for pain in well-defined categories at 5 time intervals as 12, 24, 48, 72 hours and 1 week after treatment. The VAS 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 25 mm. Mild pain included the descriptors of weak and mild pain. Moderate pain was defined as greater than 50 mm and less than 75 mm. Intense pain was defined as equal to or greater than 75 mm. Intense pain included the descriptors of strong, severe, and maximum possible.
Time Frame
Baseline, 12, 24, 48, 72 hours and 1 week.

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 healthy volunteers and who have devital premolar and molar teeth with PAI 3-5score requiring root canal treatment for first time. 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 days, have multiple teeth that required root canal treatment at the same time period; for eliminating pain referral, have root canals that could not be well-treated with orthograde root canal treatment. 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

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Effect of Different Final Irrigation Protocols on Postoperative Endodontic Pain in Devital Teeth

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