Postoperative Pain After İntracanal Procedures

February 14, 2022 updated by: Yahya Güven, Afyonkarahisar Health Sciences University

Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial

Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Post-operative pain values of the participants will be recorded and evaluated with the VAS scale.

Postoperative pain values of the techniques will be compared with statistical evaluation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study is to investigate the effects of different irrigation activation systems on pain after endodontic treatment in molar teeth with irreversible pulpitis.Materials and Methods: The study will be carried out on 140 patients with molar teeth diagnosed with irreversible pulpitis. After the root canal preparation is completed, the patients will be divided into 4 groups according to the irrigation activation system; Conventional syringe irrigation (CSI), EDDY, EndoActivator (EA) and Xp-endo Finisher (XPF). After the irrigation process is completed, the root canals will be filled using gutta-percha and canal sealer and the treatment will be completed in one session. Pain values at 6, 24, 48, 72 hours and 7 days after treatment will be evaluated at a 0.05% significance level using the Kruskal-Wallis test.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients ranging between 18 and 60 years in age
  • Patients that experienced moderate-to-severe pain represented on a visual analogue scale (VAS)
  • Maxillar and Mandibular molar teeth were diagnosed with symptomatic irreversible pulpitis

Exclusion Criteria:

  • Any systemic disease and pregnancy in the patient
  • Having used analgesic-anti-inflammatory in the last 12 hours and cortisone for the last 6 months
  • The patient has bruxism
  • Teeth with severe damage
  • Teeth with calcified canals
  • Teeth with pain to percussion
  • Teeth with periapical radiolucency
  • Teeth with root resorption
  • Teeth with an immature / open apex
  • Teeth with previous RCT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional Syringe Irrigation Group
During the final irrigation procedure, a 30 - G side vented needle was placed 2 mm shorter than the working length and was applied without agitation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.
Device: Root canal irrigation
Devices used during root canal irrigation
Other Names:
  • EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-
Experimental: Xp Endo Finisher Group
Xp Endo Finisher file was used with VDW Silver (VDW) endomotor at 800 rpm speed and 1 Ncm torque according to the manufacturer's instructions. The Xp Endo Finisher file was placed in the canal, 2 mm shorter than the working length, and was used with slow movements of 7-8 mm amplitude in the canal during activation. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.
Device: Root canal irrigation
Devices used during root canal irrigation
Other Names:
  • EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-
Experimental: EDDY Group
An EDDY tip of size 25/04 was used for sonic activation. The EDDY was placed in the duct 2 mm shorter than the working length and the activation process was performed with slow movements with an amplitude of 2-4 mm. In the irrigation process, 5 mL of 2.5% NaOCI was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.
Device: Root canal irrigation
Devices used during root canal irrigation
Other Names:
  • EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-
Experimental: Endoactivator Group
Medium Endoactivator tip of 25 / .04 size was used for irrigation activation. Medium type was placed in the canal 2 mm shorter than the working length and activation was performed by making short strokes of 2-3 mm. 5 mL of 2.5% NaOCl was applied for 1 minute for each channel. Each canal was then washed with 2 mL of 17% EDTA for 1 minute.
Device: Root canal irrigation
Devices used during root canal irrigation
Other Names:
  • EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
Time Frame: one week(7 days)
Preoperative pain of the patients before the treatment was recorded with the VAS scale. Pain levels were classified as 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain .After the treatment of the patients, a pain assessment form was given to the patient in order to evaluate the postoperative pain. Patients were asked to mark their pain levels on the VAS scale. The marking procedure was taught to the patients by a blinded researcher from the groups. When the patients came to the control appointment, VAS scales were collected and the data were analyzed.
one week(7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: yahya güven, Afyonkarahisar Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 6, 2022

Primary Completion (Anticipated)

October 6, 2022

Study Completion (Anticipated)

November 6, 2022

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AfyonkarahisarHSU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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