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Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis

Primary Purpose

Symptomatic Irreversible Pulpits

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

About this trial

This is an interventional other trial for Symptomatic Irreversible Pulpits

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who are medically free from any systemic disease that may contra indicate our interventions.
  • Patient's age between 18-65 years old.
  • Mandibular molar having vital pulps with symptomatic irreversible pulpitis because this group of patients may have more endodontic pain
  • Positive patient's acceptance for participation in the study.

Exclusion Criteria:

  • - Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain during treatment.
  • Teeth with necrotic pulp.
  • Pregnant patients or lactating because of radiographic hazards and use of analgesics.
  • Any known sensitivity or adverse reactions to ibuprofen.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    emergency pulpotomy

    complete pulp extirpation

    Arm Description

    intervention arm

    control arm

    Outcomes

    Primary Outcome Measures

    anesthetic efficacy
    measured byVerbal rating scale (VRS),unit:Binary (success/failure)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2020
    Last Updated
    October 19, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04599244
    Brief Title
    Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis
    Official Title
    Assessment of the Effect of Emergency Pulpotomy Versus Complete Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation. The rationale behind emergency pulpotomy is relieving acute dental pain caused by irreversible pulpitis. However, there is still insufficient evidence to determine whether the presence, nature and duration of clinical symptoms gives accurate information about the extent of pulp inflammation, as pulpotomy was found to be an effective emergency treatment strategy with respect to relieving clinical symptoms, even in cases of irreversible pulpitis with symptomatic apical periodontitis . Advanced diagnostic strategies are needed to determine whether there is a correlation between clinical symptoms, actual pulpal inflammation and achieving adequate pain relief during and after treatment. Thus, we are conducting this study to assess the effect of emergency pulpotomy versus complete pulp extirpation on relieving acute dental pain of symptomatic irreversible pulpitis in mandibular molars. The expected benefit for the patients is to decrease pain during and after treatment. we also are trying to provide an evidence for the clinician in order to provide the best endodontic treatment without pain.
    Detailed Description
    Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, and one of the main reasons for seeking emergency dental treatment. Pain associated with irreversible pulpitis represents more than 45% of emergency patients in dental clinics. A pulpotomy has been demonstrated as an emergency intervention for effective pain relief by removing the coronal pulp tissue without penetrating radicular pulpal tissue. Inflammation and degeneration of the pulp usually progress apically from the point of infection, so selective removal of this tissue in the form of pulpotomy is usually effective in controlling pain and patient sedation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Symptomatic Irreversible Pulpits

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    emergency pulpotomy
    Arm Type
    Experimental
    Arm Description
    intervention arm
    Arm Title
    complete pulp extirpation
    Arm Type
    Active Comparator
    Arm Description
    control arm
    Intervention Type
    Other
    Intervention Name(s)
    emergency pulpotomy
    Intervention Description
    removal of coronal pulp
    Primary Outcome Measure Information:
    Title
    anesthetic efficacy
    Description
    measured byVerbal rating scale (VRS),unit:Binary (success/failure)
    Time Frame
    During pulp extirpation and pulpotomy (30 minutes)

    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 are medically free from any systemic disease that may contra indicate our interventions. Patient's age between 18-65 years old. Mandibular molar having vital pulps with symptomatic irreversible pulpitis because this group of patients may have more endodontic pain Positive patient's acceptance for participation in the study. Exclusion Criteria: - Patients who had used any type of analgesic medication during the preceding 12 hours before the treatment to give true response of pain during treatment. Teeth with necrotic pulp. Pregnant patients or lactating because of radiographic hazards and use of analgesics. Any known sensitivity or adverse reactions to ibuprofen.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effect of Emergency Pulpotomy Versus Pulp Extirpation on Anesthetic Efficacy in Endodontic Treatment of Acute Pulpitis

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