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Intraligmentary Dexamethasone in Lower First Molars With Irreversible Pulpitis and Apical Periodontits

Primary Purpose

Pulpitis - Irreversible

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inferior alveolar nerve block with dexamethasone
Buccal infiltratation with dexamethasone
Inferior alveolar nerve block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring " irreversible pulpitis with apical periodontitis"

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age between 20-45 years old. Systemically healthy patient (ASA I or II). Lower first molar with: Preoperative sharp pain. Slight widening in the periodontal ligament (PDL). Vital response of pulp tissue to cold pulp tester (ethyl chloride spray). Exclusion Criteria: Patients allergic to anesthetics, or dexamethasone (other corticosteroids). Pregnant or nursing females. Patients having significant systemic disorder (ASA III or IV). Hemostatic disorders or anti-coagulant therapy during the last month. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before treatment. Retreatment cases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Inferior alveolar nerve block

    Inferior alveolar nerve block with intraligmentary dexamethasone

    Buccal infiltratation with intraligmentary dexamethasone

    Arm Description

    Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine

    Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for inferior alveolar nerve block and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection

    Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for buccal infiltratation and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection

    Outcomes

    Primary Outcome Measures

    Intraoperative pain
    Efficacy of buccal infiltration anesthesia and inferior alveolar nerve block measured during procedures of root canal treatment using numerical rating scale.It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10= severe pain, "10" being the most intense pain conceivable.And instruct patient to raise his hand if he feels pain to reasse if he needs supplementary anathesia

    Secondary Outcome Measures

    Post-operative pain
    Patient will record the pain on numerical rating scale (6,12,24 &48h)..It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10 = severe pain, "10" being the most intense pain conceivable
    Number of needed analgesic tablets in case of intolerable pain
    Ibuprofen 200mgm tabs have been described to patient in case of sever pain (above6)

    Full Information

    First Posted
    June 15, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05928611
    Brief Title
    Intraligmentary Dexamethasone in Lower First Molars With Irreversible Pulpitis and Apical Periodontits
    Official Title
    Effect of Intraligmentary Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block Versus Buccal Infiltratation in Lower First Molars With Irreversible Pulpitis and Apical Periodontits: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    September 2024 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Using intraligmentary dexamethasone to reduce the pain intensity during and after root canal preparation
    Detailed Description
    Aim :asseing the effect of intraligmentary dexamethasone on anesthetic efficacy of inferior alveolar nerve block and buccal infiltratation in lower first molar with irreversible pulpitis and apical periodontits, dexamethasone has antiinflammatory effect so it will improve the efficacy of anathesia and reduce postoperative by inhibition the production of phosopholipase and reduction of prostaglandins synthesis Methods: diagnose the case clinically and readiographically Patients will divide into 3 groups First group will be given inferior alveolar nerve block 4%articaine Hcl1:100 epinephrine Second group will be given inferior alveolar nerve block 4%articaine with intraligmentary dexamethasone Third group will be given buccal infiltratation 4%articaine with intraligmentary dexamethasone After anathesia ,make access cavity and reduce the occulsa surface and make it out of occulsion . Working length determination will be done by apex locator and confirm it by x ray . Mechanical preparation will be done by FANTA files and apply EDTA on files Irrigate the canal by Naocl 2.5٪ Complete the root canal preparation through single visit. Obturate the canal by single cone technique and bioceramic sealer. During procedures , record pain intensity on HP visual scale Follow up the patient after 6,12,24 and 48 hours Describe Ibuprofen 200mg in case of sever pain Conclusion : it's predictable that the intraligmentary dexamethasone will reduce the pain during and after root canal procedures

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible
    Keywords
    " irreversible pulpitis with apical periodontitis"

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    81 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Inferior alveolar nerve block
    Arm Type
    Active Comparator
    Arm Description
    Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine
    Arm Title
    Inferior alveolar nerve block with intraligmentary dexamethasone
    Arm Type
    Experimental
    Arm Description
    Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for inferior alveolar nerve block and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection
    Arm Title
    Buccal infiltratation with intraligmentary dexamethasone
    Arm Type
    Experimental
    Arm Description
    Using 1.8ml of 4% articaine HCL 1:100,000 epinehrine for buccal infiltratation and 0.4 mL of 8 mg/ 2mLdexamethasone for intraligmentary injection
    Intervention Type
    Procedure
    Intervention Name(s)
    Inferior alveolar nerve block with dexamethasone
    Intervention Description
    Using articaine for inferior alveolar block with intraligmentary dexamethasone
    Intervention Type
    Procedure
    Intervention Name(s)
    Buccal infiltratation with dexamethasone
    Intervention Description
    Using articaine for buccal infiltratation with intraligmentary dexamethasone
    Intervention Type
    Procedure
    Intervention Name(s)
    Inferior alveolar nerve block
    Intervention Description
    Using articaine for injection
    Primary Outcome Measure Information:
    Title
    Intraoperative pain
    Description
    Efficacy of buccal infiltration anesthesia and inferior alveolar nerve block measured during procedures of root canal treatment using numerical rating scale.It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3 = mild pain, 4-6= moderate pain, 7-10= severe pain, "10" being the most intense pain conceivable.And instruct patient to raise his hand if he feels pain to reasse if he needs supplementary anathesia
    Time Frame
    During procedure
    Secondary Outcome Measure Information:
    Title
    Post-operative pain
    Description
    Patient will record the pain on numerical rating scale (6,12,24 &48h)..It is a line numbered from 0-10 , where pain levels are categorized as follows: 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10 = severe pain, "10" being the most intense pain conceivable
    Time Frame
    After procedure until 48hour
    Title
    Number of needed analgesic tablets in case of intolerable pain
    Description
    Ibuprofen 200mgm tabs have been described to patient in case of sever pain (above6)
    Time Frame
    After procedure until 48hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 20-45 years old. Systemically healthy patient (ASA I or II). Lower first molar with: Preoperative sharp pain. Slight widening in the periodontal ligament (PDL). Vital response of pulp tissue to cold pulp tester (ethyl chloride spray). Exclusion Criteria: Patients allergic to anesthetics, or dexamethasone (other corticosteroids). Pregnant or nursing females. Patients having significant systemic disorder (ASA III or IV). Hemostatic disorders or anti-coagulant therapy during the last month. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 h before treatment. Retreatment cases.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wafaa R Elshafaey
    Phone
    00201020773887
    Email
    wafaa.elshafaey@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed M Abi Elhassan, Phd
    Phone
    0020 111 167 7707
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Angie G Ghoneim
    Organizational Affiliation
    Faculty of oral and dental medicine,Cairo university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Intraligmentary Dexamethasone in Lower First Molars With Irreversible Pulpitis and Apical Periodontits

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