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
About this trial
This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Intarligamentary, Articaine, Lidocaine
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
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
NCT ID
NCT02807298
First Posted
June 9, 2016
Last Updated
June 20, 2016
Sponsor
Dr. D. Y. Patil Dental College & Hospital
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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