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Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Needle-less jet anaesthesia
Conventional Injection Anesthesia
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Irreversible Pulpitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age range 18-50 Males and females Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II) Patients accepting to participate in the trial Patients who can understand pain scale and can sign the informed consent Mature maxillary molars with symptomatic irreversible pulpitis Exclusion Criteria: Medically compromised patients having significant systemic disorders (ASA III or IV). Pregnant females Teeth with necrotic pulps Non-restorable or periodontally hopeless teeth Patients on analgesic or anti-inflammatory drugs 12 hours prior to treatment Patients allergic to any of the components of the anesthetic solution

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Needle-less jet anaesthesia

    Conventional injection anaesthesia

    Arm Description

    Infiltration anaesthesia without needle

    Regular infiltration anaesthesia

    Outcomes

    Primary Outcome Measures

    Intra operative pain
    Using NRS score

    Secondary Outcome Measures

    Onset of pulpal anaesthesia
    Electric pulp tester will be used to measure the time taken for gaining profound anesthesia

    Full Information

    First Posted
    November 25, 2022
    Last Updated
    February 2, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05724862
    Brief Title
    Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques
    Official Title
    Evaluation of Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques in Patients With Symptomatic Irreversible Pulpitis in Maxillary Molars: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2024 (Anticipated)
    Study Completion Date
    April 1, 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

    5. Study Description

    Brief Summary
    Pain despite being a physiological experience, is considerably affected by the emotional states, such as anxiety and fear. It was demonstrated that individuals with a high level of anxiety experience difficult anesthesia and more painful procedures during different dental treatments. Besides, the level of anxiety was established as one of the most crucial predictors of dental anesthesia level. Techniques and equipment such as topical anesthetic, cold spray, applying pressure, vibratory devices, distraction techniques, sedation medications, have been developed and utilized to reduce pain or fear of dental injections or increase the efficacy of anesthesia. However it is the sight and sensation of a needle that was found by almost 25% of patients to be extremely anxiety provoking stimuli in a survey to determine what dental patients truly fear. Therefore, Needleless devices that were developed to provide anesthesia without injections would reduce patients' apprehension and anxiety levels resulting in a profound anesthesia for a proper duration of time
    Detailed Description
    The aim of the study, treatment procedures, possible side effects and treatment alternatives will be explained to the patients. Patients will be asked to follow the general instructions and sign a printed informed consent. Patients will be asked to fill the outcomes data charts honestly and accurately. Eligible patients will be randomly divided into two equal groups according to randomization mechanism: Group 1 (Comfort-In Jet Anesthesia) and Group 2 (Local Infiltration Anesthesia) Pre-operative measures (for all groups): Medical and dental history will be obtained from all participants, clinical and radiographic evaluation for each tooth included in this study will be recorded. Clinical diagnosis of symptomatic irreversible pulpitis will be confirmed based on both subjective and objective findings. The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrolment. Pain scale chart will be explained to each participant in order to be used after administration of local anaesthesia. Intervention group (G1): Teeth will be anaesthetized using the Comfort-In Jet device by administering 1 ml of 4% Articaine buccally and 0.5 ml palatally. Control group (G2): Teeth will be anaesthetized using conventional infiltration anaesthesia by administering 1 ml of 4% Articaine buccally and 0.5 ml palatally. Each patient will record the level of discomfort during administration of anaesthesia in the pain scale chart (NRS). Profound pulpal anaesthesia will be checked using an electric pulp tester reading every one minute after anesthetic administration up to ten minutes. Teeth that fail to reach profound pulpal anaesthesia will receive a rescue dose of the same anaesthetic solution (4% Articaine) using the conventional injection technique, if needed, intra-ligamentary injection will be used followed by intra-pulpal anaesthesia in case of persistent pain. After confirming profound pulpal anaesthesia single visit root canal treatment will be performed. Access cavity preparation will be done using round burs and tapered diamond stones and patients will be asked to report any pain and/or discomfort during this step. The pain intensity will be recorded on the NRS. Teeth will be isolated with rubber dam and working length will be obtained by an apex locator and confirmed radiographically to be 0.5 to 1 mm from the radiographic apex. All canals will be prepared with crown down techniques using EdgeEndo rotary files depending on the initial size of the canals. Irrigation will be done using 2 ml of 2.5% NaOCl between each two successive files, then, all canals will have a final flush with 5 ml of 17% EDTA for 1 minute followed by 5 ml of distilled water, 5ml of 2.5% NaOCl and finally 5 ml of distilled water in order to remove any residual chemicals from canals. Pain incidence and intensity during mechanical preparation will also be reported by the patients and recorded on the NRS. After complete preparation canals will be dried and obturated in the same visit and teeth will be temporized. Patients will receive postoperative instructions, and will be allowed to call the operator in case of moderate or severe postoperative pain and if needed, an emergency visit will be scheduled.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Needle-less jet anaesthesia
    Arm Type
    Experimental
    Arm Description
    Infiltration anaesthesia without needle
    Arm Title
    Conventional injection anaesthesia
    Arm Type
    Active Comparator
    Arm Description
    Regular infiltration anaesthesia
    Intervention Type
    Device
    Intervention Name(s)
    Needle-less jet anaesthesia
    Intervention Description
    Infiltration anesthesia without needle depending on injection pressure
    Intervention Type
    Device
    Intervention Name(s)
    Conventional Injection Anesthesia
    Intervention Description
    Regular Infiltration local anesthesia
    Primary Outcome Measure Information:
    Title
    Intra operative pain
    Description
    Using NRS score
    Time Frame
    Up to One hour
    Secondary Outcome Measure Information:
    Title
    Onset of pulpal anaesthesia
    Description
    Electric pulp tester will be used to measure the time taken for gaining profound anesthesia
    Time Frame
    Up to Ten minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age range 18-50 Males and females Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II) Patients accepting to participate in the trial Patients who can understand pain scale and can sign the informed consent Mature maxillary molars with symptomatic irreversible pulpitis Exclusion Criteria: Medically compromised patients having significant systemic disorders (ASA III or IV). Pregnant females Teeth with necrotic pulps Non-restorable or periodontally hopeless teeth Patients on analgesic or anti-inflammatory drugs 12 hours prior to treatment Patients allergic to any of the components of the anesthetic solution
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nader W Ramsis
    Phone
    01225321044
    Email
    nader.wadie@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shaimaa I Bakry
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy of Pulpal Anesthesia and Patient Preference Using the Needle-less and Conventional Injection Techniques

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