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

NCT ID: NCT02807298

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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).

Conditions

Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2% Lignocaine (lidocaine)

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

Group Type: ACTIVE_COMPARATOR

2% Lignocaine

Intervention Type: DRUG

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

Epinephrine

Intervention Type: DRUG

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

4% Articaine

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

Group Type: EXPERIMENTAL

4%articaine

Intervention Type: DRUG

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

Epinephrine

Intervention Type: DRUG

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

Interventions

4%articaine

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

Intervention Type: DRUG

2% Lignocaine

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

Intervention Type: DRUG

Epinephrine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dr. D. Y. Patil Dental College & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soumya Shetty

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 10969438 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 7943919 (View on PubMed)

Other Identifiers

DYPDCH/IEC-SS/18/2014

Identifier Type: -

Identifier Source: org_study_id