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Postoperative Pain After İntracanal Procedures

Primary Purpose

Endodontically Treated Teeth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal irrigation
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring EDDY, EndoActivatör, Xp-endo Finisher, Postoperative pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Conventional Syringe Irrigation Group

    Xp Endo Finisher Group

    EDDY Group

    Endoactivator Group

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 11, 2021
    Last Updated
    February 14, 2022
    Sponsor
    Afyonkarahisar Health Sciences University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04892355
    Brief Title
    Postoperative Pain After İntracanal Procedures
    Official Title
    Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 6, 2022 (Anticipated)
    Primary Completion Date
    October 6, 2022 (Anticipated)
    Study Completion Date
    November 6, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Afyonkarahisar Health Sciences University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endodontically Treated Teeth
    Keywords
    EDDY, EndoActivatör, Xp-endo Finisher, Postoperative pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    4-group clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional Syringe Irrigation Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Xp Endo Finisher Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    EDDY Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Endoactivator Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Root canal irrigation
    Other Intervention Name(s)
    EndoActivator (Dentsply Tulsa Dental Specialties, Tulsa, OK)-XP-endo Finisher (XPF; FKG Dentaire SA, La Chaux-de-Fonds, Switzerland)- EDDY (EDDY; VDW, Munich, Germany)-
    Intervention Description
    Devices used during root canal irrigation
    Primary Outcome Measure Information:
    Title
    Postoperative Pain After İntracanal Procedures Based On Different İrrigation Activation Tecniques: A Randomized, Clinical Trial
    Description
    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.
    Time Frame
    one week(7 days)

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    No gender discrimination will be applied in the study.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    yahya güven
    Phone
    05314599583
    Email
    yahyaguven52@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    yahya güven
    Organizational Affiliation
    Afyonkarahisar Health Sciences University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Postoperative Pain After İntracanal Procedures

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