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

NCT02807298 | Completed Phase 3

• 1 other identifier: DYPDCH/IEC-SS/18/2014
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Irreversible Pulpitis

Keywords

Intarligamentary; Articaine; Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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,

  baseline

Study Arms (2)

2% Lignocaine (lidocaine)

ACTIVE COMPARATOR

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

Drug: 2% Lignocaine; Drug: Epinephrine

4% Articaine

EXPERIMENTAL

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

Drug: 4%articaine; Drug: Epinephrine

Interventions

4%articaine DRUG

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

4% Articaine

2% Lignocaine DRUG

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

2% Lignocaine (lidocaine)

Epinephrine DRUG

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

2% Lignocaine (lidocaine); 4% Articaine

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead

Related Publications (2)

• 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.

  PMID: 10969438 BACKGROUND

• Vahatalo K, Antila H, Lehtinen R. Articaine and lidocaine for maxillary infiltration anesthesia. Anesth Prog. 1993;40(4):114-6.

  PMID: 7943919 BACKGROUND

MeSH Terms

Interventions

Lidocaine; Epinephrine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 21, 2016

Record last verified: 2016-06