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Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root canal obturation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Permanent teeth with fully formed apex
  • Teeth with vital pulp
  • Teeth with no periapical radiolucency
  • Patients having preoperative pain

Exclusion Criteria:

  • Teeth with incompletely formed apex
  • Teeth requiring secondary endodontic treatment
  • Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients,
  • Patients taking anti-inflammatory or antibiotics
  • Patients giving history of analgesic or antibiotic intake 1 week before treatment
  • Patients below 18 years of age,
  • Patients above 65 years of age
  • Patients having history of peptic ulcer or gastrointestinal bleeding,
  • Teeth having calcified canals,
  • Teeth having multiple canals or multirooted teeth,
  • Teeth affected with periodontal disease.
  • Teeth tender on percussion,
  • Teeth having procedural errors such as transportation, perforation, and missed canals

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ah-Plus sealer

    Endosequence BC sealer

    Arm Description

    Root canal sealer which is a resin-based formula with excellent radiopacity , low shrinkage , low solubility and outstanding flow characteristics . It features a 1:1 , paste-to-paste mixing system for fast , easy preparation and less waste . It is biocompatible and silver free .

    It is a root canal sealer which is premixed ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications. It is insoluble , radiopaque and aluminum-free material based on calcium silicate composition , which requires the presence of water to set and hardens . It does not shrink during setting and demonstrate excellent physical properties .

    Outcomes

    Primary Outcome Measures

    Intensity of postoperative pain
    Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
    Intensity of postoperative pain
    Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
    Intensity of postoperative pain
    Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment

    Secondary Outcome Measures

    intensity of postoperative pain
    Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
    intensity of postoperative pain
    Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
    intensity of postoperative pain
    Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment

    Full Information

    First Posted
    July 16, 2020
    Last Updated
    July 20, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04482101
    Brief Title
    Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers
    Official Title
    Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers : A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2021 (Anticipated)
    Study Completion Date
    July 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this randomized clinical trial was to compare the potential effects of resin-based and bio ceramic sealers on the occurrence and intensity of postoperative pain in patients with asymptomatic apical periodontitis (AAP) .
    Detailed Description
    Reports about postoperative pain in endodontics range from 3%-58% in different studies . Pain can be provoked by mechanical, chemical, or microbiological injuries to periodontal tissues . A number of treatment related parameters have been shown to be associated with the presence of postoperative pain, including working length (WL) estimation with an apex locator connected to every file , the number of visits , the choice of instrumentation , and the choice of root canal sealer . Sealers placed in the root canals interfere with periodontal tissues through the apical foramina, lateral canals, or leaching and can potentially affect the healing process in the periodontium. Thus, the local inflammation caused by root canal obturation materials may result in postoperative pain. The intensity of inflammatory reactions depends on a number of different factors, including the composition of the sealer . The use of a sealer during root canal obturation is essential for success of root canal treatment. The sealer has various functions: Attainment of impervious seal Filler for canal irregularities and minor discrepancies between the root canal wall and core-filling material Expressed through lateral or accessory canals Can assist in microbial control Act as lubricant Can have adhesive property to dentin The evolution of newer techniques, instruments, materials, and better understanding of canal anatomy, has changed the face of endodontics completely. One concept that has emerged is the single-visit root canal therapy. Single-visit root canal treatment (RCT) has become a common practice and offers several advantages, including a reduced flare-up rate, decreased number of operative procedures, and no risk of interappointment leakage through temporary restorations. The major consideration regarding one-appointment endodontics has been the concern about postoperative pain . Various studies have evaluated the post-endodontic pain difference between single- and multiple-visit RCT, but most studies have ruled out any significant difference in postoperative pain . It has been suggested that bioceramic materials improve the outcome of endodontic treatment by promoting the differentiation of odontoblasts and by releasing biologically active substances . The bioceramic materials have been shown to be less cytotoxic compared with resin-based AH Plus (Dentsply Maillefer, Ballaigues, Switzerland) in vitro . However, AH Plus (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) exhibited stronger bonding capacity and higher radiopacity compared with bioceramic sealers. The clinical significance of these characteristics is still unclear. Data on the clinical behavior of bioceramic sealers are scarce and of great interest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ah-Plus sealer
    Arm Type
    Experimental
    Arm Description
    Root canal sealer which is a resin-based formula with excellent radiopacity , low shrinkage , low solubility and outstanding flow characteristics . It features a 1:1 , paste-to-paste mixing system for fast , easy preparation and less waste . It is biocompatible and silver free .
    Arm Title
    Endosequence BC sealer
    Arm Type
    Experimental
    Arm Description
    It is a root canal sealer which is premixed ready-to-use injectable bioceramic cement paste developed for permanent root canal filling and sealing applications. It is insoluble , radiopaque and aluminum-free material based on calcium silicate composition , which requires the presence of water to set and hardens . It does not shrink during setting and demonstrate excellent physical properties .
    Intervention Type
    Other
    Intervention Name(s)
    Root canal obturation
    Other Intervention Name(s)
    Root canal sealer
    Intervention Description
    Root canal filling
    Primary Outcome Measure Information:
    Title
    Intensity of postoperative pain
    Description
    Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
    Time Frame
    6th hours
    Title
    Intensity of postoperative pain
    Description
    Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
    Time Frame
    12th hours
    Title
    Intensity of postoperative pain
    Description
    Intensity of postoperative pain after using two types of sealers will be measured using a visual analog scale (VAS) after treatment
    Time Frame
    24th hours
    Secondary Outcome Measure Information:
    Title
    intensity of postoperative pain
    Description
    Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
    Time Frame
    48th hours
    Title
    intensity of postoperative pain
    Description
    Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
    Time Frame
    72nd hours
    Title
    intensity of postoperative pain
    Description
    Intensity of postoperative pain will be measured using a visual analog scale (VAS) after treatment
    Time Frame
    5th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Permanent teeth with fully formed apex Teeth with vital pulp Teeth with no periapical radiolucency Patients having preoperative pain Exclusion Criteria: Teeth with incompletely formed apex Teeth requiring secondary endodontic treatment Patients having complicating systemic disease such as diabetes, malignancy, pregnancy, central nervous system disorders, Cardiovascular system disorders, respiratory disorders, asthma patients, psychiatric disorders, immunocompromised patients, Patients taking anti-inflammatory or antibiotics Patients giving history of analgesic or antibiotic intake 1 week before treatment Patients below 18 years of age, Patients above 65 years of age Patients having history of peptic ulcer or gastrointestinal bleeding, Teeth having calcified canals, Teeth having multiple canals or multirooted teeth, Teeth affected with periodontal disease. Teeth tender on percussion, Teeth having procedural errors such as transportation, perforation, and missed canals
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muna Mohamed, master
    Phone
    00201277974490
    Email
    muna.abubaker@dentisrty.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba ElAsfouri, PHD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hany Sadek, PHD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29571915
    Citation
    Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
    Results Reference
    result
    PubMed Identifier
    30397735
    Citation
    Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.
    Results Reference
    result

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    Single Visit Root Canal Treatment :Incidence of Postoperative Pain Using Two Different Sealers

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