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4% Articaine and 2% Lidocaine by Intraligamentary Technique in Irreversible Pulpitis

Primary Purpose

Irreversible Pulpitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
4%articaine
2% Lignocaine
Epinephrine
Sponsored by
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Intarligamentary, Articaine, Lidocaine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Irreversible pulpitis in the bilateral first or second mandibular molars.
  • Absence of periapical radiolucency on the periapical radiographs(except for periapical widening) confirmed the presence of irreversible pulpitis in the teeth.

Exclusion Criteria:

  • Pregnant women,
  • Patients with systemic disease .
  • Teeth with Previous endodontic therapy, large restorations, full crowns, periodontal diseases, or restoration with poor margins were eliminated from the study.
  • Also teeth with a history of trauma or sensitivity were eliminated.
  • Patients taken antibiotics or analgesics in previous 3 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    2% Lignocaine (lidocaine)

    4% Articaine

    Arm Description

    Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine (adrenaline)

    intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine (adrenaline)

    Outcomes

    Primary Outcome Measures

    Pain scale as measured by The Heft Parker Visual scale (HP-VAS)
    HP-VAS was a 170mm line divided into different categories of pain. Different marks on the line show a description of a certain pain level. Absence of pain corresponded to 0mm. mild pain with the descriptors of faint, weak, and mild pain corresponded to 0mm to 54mm, Moderate pain corresponded to greater than 54mm upto 114mm, and Severe pain with the descriptors of strong, intense, and maximum possible amount of pain corresponded to greater than 114mm upto 170mm. Patients were asked to rate their initial pain on a HP-VAS,

    Secondary Outcome Measures

    Full Information

    First Posted
    June 9, 2016
    Last Updated
    June 20, 2016
    Sponsor
    Dr. D. Y. Patil Dental College & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02807298
    Brief Title
    4% Articaine and 2% Lidocaine by Intraligamentary Technique in Irreversible Pulpitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. D. Y. Patil Dental College & Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    This study compared the anesthetic efficacy between Lignocaine and articaine administering it intraligamentarly using ligajet in twenty five female patients having irreversible pulpitis on bilateral mandibular molars. At 5minutes of post injection, the teeth were isolated with rubber dam and access performed. Patients were instructed to definitively rate any pain felt during endodontic procedure. If patient felt pain, the treatment was immediately stopped and the patient rated their discomfort using Heft Parker VAS. The extent of access achieved when the patient felt pain was recorded as within dentin, entering the pulp chamber or initial file placement. The success was defined as the ability to access and instrument the tooth without pain (VAS score of zero) or mild pain (VAS rating<54mm).
    Detailed Description
    The present clinical study was carried out to compare the anaesthetic success of 4% articaine with 2% lidocaine for intraligamentary anaesthesia in patients having irreversible pulpitis. Subjects randomly received two intraligamentary injections using Ligaject at a two separate appointments spared one week apart in a cross over design. Twenty patients received intraligamentary injections of 0.9 ml of 4%articaine with 1:100,000 epinephrine (Septodont INC) at first appointment and 1.8 ml of lidocaine with 1:100,000 epinephrine. Each patient served as her own control. All injections were given by the same physician or author. The injection was performed by inserting the needle at the gingival sulcus at the mesio-buccal line angle of the tooth with needle directed at approximately 30degrees angle to the long axis of the tooth in the buccolingual plane. Needle was placed into the sulcus with the bevel placing away from the tooth and towards the alveolar bone. Needle was advanced with a firm pressure until it could be advanced no further. The operator waited 10 seconds before slowly removing the needle from the injection site. This step supposedly allows the anaesthetic solution to dissipate within the tissue and reduces the amount of anaesthetic solution to dissipate within the tissue and reduces the amount of solution dripping from the site before needle withdrawal. However, in almost all cases some anaesthetic solution escaped upon removal of needle from the sulcus. Five minutes post injection, the teeth were isolated under rubber dam isolation and investigator performed the access cavity. Patients were instructed to definitely rate any pain felt during endodontic procedure. If patient felt pain, the treatment was immediately stopped and the patient rated her discomfort using Heft Parker VAS. The extent of access achieved when the patient felt pain was recorded as within dentin, entering the pulp chamber or initial file placement. The success was defined as the ability to access and instrument the tooth without pain (VAS score of zero) or mild pain (VAS rating<54mm).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irreversible Pulpitis
    Keywords
    Intarligamentary, Articaine, Lidocaine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2% Lignocaine (lidocaine)
    Arm Type
    Active Comparator
    Arm Description
    Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine (adrenaline)
    Arm Title
    4% Articaine
    Arm Type
    Experimental
    Arm Description
    intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine (adrenaline)
    Intervention Type
    Drug
    Intervention Name(s)
    4%articaine
    Intervention Description
    intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine
    Intervention Type
    Drug
    Intervention Name(s)
    2% Lignocaine
    Intervention Description
    Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
    Intervention Type
    Drug
    Intervention Name(s)
    Epinephrine
    Intervention Description
    Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
    Primary Outcome Measure Information:
    Title
    Pain scale as measured by The Heft Parker Visual scale (HP-VAS)
    Description
    HP-VAS was a 170mm line divided into different categories of pain. Different marks on the line show a description of a certain pain level. Absence of pain corresponded to 0mm. mild pain with the descriptors of faint, weak, and mild pain corresponded to 0mm to 54mm, Moderate pain corresponded to greater than 54mm upto 114mm, and Severe pain with the descriptors of strong, intense, and maximum possible amount of pain corresponded to greater than 114mm upto 170mm. Patients were asked to rate their initial pain on a HP-VAS,
    Time Frame
    baseline

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Irreversible pulpitis in the bilateral first or second mandibular molars. Absence of periapical radiolucency on the periapical radiographs(except for periapical widening) confirmed the presence of irreversible pulpitis in the teeth. Exclusion Criteria: Pregnant women, Patients with systemic disease . Teeth with Previous endodontic therapy, large restorations, full crowns, periodontal diseases, or restoration with poor margins were eliminated from the study. Also teeth with a history of trauma or sensitivity were eliminated. Patients taken antibiotics or analgesics in previous 3 months

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10969438
    Citation
    Malamed SF, Gagnon S, Leblanc D. A comparison between articaine HCl and lidocaine HCl in pediatric dental patients. Pediatr Dent. 2000 Jul-Aug;22(4):307-11.
    Results Reference
    background
    PubMed Identifier
    7943919
    Citation
    Vahatalo K, Antila H, Lehtinen R. Articaine and lidocaine for maxillary infiltration anesthesia. Anesth Prog. 1993;40(4):114-6.
    Results Reference
    background

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    4% Articaine and 2% Lidocaine by Intraligamentary Technique in Irreversible Pulpitis

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