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

June 20, 2016 updated by: Soumya Shetty, Dr. D. Y. Patil Dental College & Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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: Epinephrine
Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
Drug: 4%articaine
intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. D. Y. Patil Dental College & Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYPDCH/IEC-SS/18/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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