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

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ClinicalTrials.gov Identifier: NCT02807298
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital

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).

Condition or disease Intervention/treatment Phase
Irreversible Pulpitis Drug: 4%articaine Drug: 2% Lignocaine Drug: Epinephrine Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2% Lignocaine (lidocaine)
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine (adrenaline)
Drug: 2% Lignocaine
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine

Drug: Epinephrine
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine

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

Drug: Epinephrine
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine




Primary Outcome Measures :
  1. Pain scale as measured by The Heft Parker Visual scale (HP-VAS) [ Time Frame: baseline ]
    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,



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Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Publications:
Layout table for additonal information
Responsible Party: Soumya Shetty, Dr., Dr. D. Y. Patil Dental College & Hospital
ClinicalTrials.gov Identifier: NCT02807298    
Other Study ID Numbers: DYPDCH/IEC-SS/18/2014
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Keywords provided by Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital:
Intarligamentary
Articaine
Lidocaine
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Lidocaine
Epinephrine
Racepinephrine
Carticaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics