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Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling

Primary Purpose

Necrotic Pulp, Single Root Teeth

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bioceramic sealer
MTA
resin sealer
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp

Eligibility Criteria

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

Inclusion Criteria:

  • Patients requiring root canal treatment of single canal necrotic teeth.
  • Patient from 18 to 60 years old
  • Patients with Asymptomatic apical periodontitis.
  • Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al

Exclusion Criteria:

  • Teeth with incompletely formed apex

    • Teeth requiring retreatment
    • 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 affected with periodontal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    endo sequence bioceramic sealer

    MTA fill apex calcium silicate base sealer

    AH plus resin sealer

    Arm Description

    obturation using Endo-sequence BC sealer

    obturation using calcium-silicates based MTA fill-apex sealer

    obturation using AH Plus sealer

    Outcomes

    Primary Outcome Measures

    Intensity of post-operative pain
    Measurement of post-operative pain by Visual analogue scale
    Intensity of post-operative pain
    Measurement of post-operative pain by Visual analogue scale
    Intensity of post-operative pain
    Measurement of post-operative pain by Visual analogue scale
    Intensity of post-operative pain
    Measurement of post-operative pain by Visual analogue scale
    Intensity of post-operative pain
    Measurement of post-operative pain by Visual analogue scale

    Secondary Outcome Measures

    post operative swelling
    Yes or no yes or no

    Full Information

    First Posted
    May 27, 2022
    Last Updated
    June 13, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05419752
    Brief Title
    Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling
    Official Title
    Assessment of 3 Different Root Canal Obturating Sealers on Postoperative Pain and Swelling in Single Canal Necrotic Teeth With a Single Visit .a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 30, 2022 (Anticipated)
    Primary Completion Date
    August 30, 2022 (Anticipated)
    Study Completion Date
    August 30, 2022 (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
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    aim of the study will be conducted to compare the effect of MTA fill apex sealer and endo sequence bioceramic sealer in obturation on the intenisty of postoperative pain and the incidence of post operative swelling in patient with necrotic teeth .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp, Single Root Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    endo sequence bioceramic sealer
    Arm Type
    Experimental
    Arm Description
    obturation using Endo-sequence BC sealer
    Arm Title
    MTA fill apex calcium silicate base sealer
    Arm Type
    Experimental
    Arm Description
    obturation using calcium-silicates based MTA fill-apex sealer
    Arm Title
    AH plus resin sealer
    Arm Type
    Experimental
    Arm Description
    obturation using AH Plus sealer
    Intervention Type
    Drug
    Intervention Name(s)
    bioceramic sealer
    Other Intervention Name(s)
    endosequence
    Intervention Description
    bioceramic based obturating sealer
    Intervention Type
    Drug
    Intervention Name(s)
    MTA
    Other Intervention Name(s)
    MTA fill apex
    Intervention Description
    MTA based obturating sealer
    Intervention Type
    Drug
    Intervention Name(s)
    resin sealer
    Other Intervention Name(s)
    AH Plus resin sealer
    Intervention Description
    resin based obturating sealer
    Primary Outcome Measure Information:
    Title
    Intensity of post-operative pain
    Description
    Measurement of post-operative pain by Visual analogue scale
    Time Frame
    6 hours
    Title
    Intensity of post-operative pain
    Description
    Measurement of post-operative pain by Visual analogue scale
    Time Frame
    12 hours
    Title
    Intensity of post-operative pain
    Description
    Measurement of post-operative pain by Visual analogue scale
    Time Frame
    24 hours
    Title
    Intensity of post-operative pain
    Description
    Measurement of post-operative pain by Visual analogue scale
    Time Frame
    48 hours
    Title
    Intensity of post-operative pain
    Description
    Measurement of post-operative pain by Visual analogue scale
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    post operative swelling
    Description
    Yes or no yes or no
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients requiring root canal treatment of single canal necrotic teeth. Patient from 18 to 60 years old Patients with Asymptomatic apical periodontitis. Teeth presenting with no clinical symptoms and with a periapical score from 2 to 4 according to Orstavik et al Exclusion Criteria: Teeth with incompletely formed apex Teeth requiring retreatment 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 affected with periodontal disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elsayed Hany Elmasry, bsc
    Phone
    00201159536873
    Email
    elsayed.hany@dentistry.cu.edu.eg

    12. IPD Sharing Statement

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    Clinical Assessment of 3 Differant Obturation Sealers on Postoprative Pain and Swelling

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