Clinical trial NCT06862570: Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis
Official title: Assessment of Local Anaesthesia Effectiveness Using Electric Pulp Tester in Symptomatic Irreversible Pulpitis Using 2% Lignocaine and 4% Articaine As Supplemental Anaesthetic Agents: an in Vivo Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Symptomatic Irreversible Pulpitis
Keywords: Lignocaine, Articaine and Supplemental Buccal Infiltration
Lead sponsor: 28 Military Dental Centre Lahore
Sponsor class: OTHER_GOV
First posted: 2025-03-06
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the comparative efficacy of two different local anaesthetic agents for supplemental buccal infiltration after a failed inferior alveolar nerve block in achieving profound pulpal anaesthesia for symptomatic irreversible pulpitis using 2% lignocaine and 4% articaine with vasoconstrictor epinephrine.

Alternate hypothesis:

There is a mean difference in local anaesthesia effectiveness of 2% lignocaine and 4% articaine containing epinephrine when used for buccal infiltration in pulpectomy of symptomatic irreversible pulpitis of mandibular posterior teeth after a failed inferior alveolar nerve block

Detailed description: Patients diagnosed with symptomatic irreversible pulpitis are included in this study. Teeth will be divided into two groups after a failed inferior alveolar nerve block using 2% lignocaine containing 1:100,000 epinephrine. A sample size of 123, with the first group consisting of 62 patients, 2 cartridges of 32mg of 2% lignocaine with 1:100,000 epinephrine will be used for supplemental buccal infiltration. In group 2 of 61 patients, 40mg of 4% articaine with 1:100,000 epinephrine will be used. During the root canal treatment, a subjective assessment of lip anesthesia is recorded. An electric pulp tester is used for the evaluation of the presence or absence of pulpal anesthesia. A verbal analogue scale is also used to evaluate the presence or absence of pain.

After taking a brief history, informed consent will be taken. A rubber dam will be used. Electric pulp tester will be used on the control contralateral tooth, the experimental tooth preoperatively; after giving nerve block and achieving Lip numbness, the experimental tooth will again be evaluated with Electric pulp tester. An access cavity will be made. If there is still no pulpal anesthesia, supplemental anesthesia will be administered and Electric pulp tester will be used again.

A questionnaire containing a numerical rating scale will be given to each patient to record the intensity of pain felt after giving supplemental anesthesia.

Eligibility criteria: Inclusion Criteria:

1. Patients with ages ranging from 18-to 55 years
2. Male/ Female
3. Mandibular posterior teeth with symptomatic irreversible pulpitis
4. Ability to understand the use of the pain scale
5. Patients with adequate oral hygiene and willing to participate in the study

Exclusion Criteria:

1. Any type of medication consumed before treatment
2. Patients who do not show profound lip numbness after giving inferior alveolar block
3. Periapical pathologies ( periapical abscess, sinus tract, periapical cyst, pulpal necrosis)
4. External resorption
5. Unfavorable location of the tooth, internal ankylosis, trismus, severe tooth malposition.

Primary outcomes:
measure: Assessment of Local anaesthsia effectiveness in symptomatic irreversible pulpitis after afailed inferior alveolar nerve block using supplemental buccal infiltration
timeFrame: 5-10 minutes after administrating supplemental buccal infiltration
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Zahra Zubir
state: Punjab
Study officials:
affiliation: 28 Military Dental Centre
name: Zahra Zubair, BDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shapiro MR, McDonald NJ, Gardner RJ, Peters MC, Botero TM. Efficacy of Articaine versus Lidocaine in Supplemental Infiltration for Mandibular First versus Second Molars with Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Endod. 2018 Apr;44(4):523-528. doi: 10.1016/j.joen.2017.10.003. Epub 2018 Feb 1.
citation: Janiani P, Gurunathan D. Effectiveness of Pre-administered Natural Sweet-tasting Solution for Decreasing Pain Associated with Dental Injections in Children: A Split-mouth Randomized Controlled Trial. J Contemp Dent Pract. 2021 Dec 1;22(12):1434-1437.
citation: Oghabi N, Renton T. Optimizing Local Anaesthetic Practice: Addressing Misconceptions and Minimizing Anaesthetic Failures. Dent Update. 2022;49(1):32-38.
citation: Martin E, Nimmo A, Lee A, Jennings E. Articaine in dentistry: an overview of the evidence and meta-analysis of the latest randomised controlled trials on articaine safety and efficacy compared to lidocaine for routine dental treatment. BDJ Open. 2021 Jul 17;7(1):27. doi: 10.1038/s41405-021-00082-5.
citation: Dianat O, Mozayeni MA, Layeghnejad MK, Shojaeian S. The efficacy of supplemental intraseptal and buccal infiltration anesthesia in mandibular molars of patients with symptomatic irreversible pulpitis. Clin Oral Investig. 2020 Mar;24(3):1281-1286. doi: 10.1007/s00784-019-03006-8. Epub 2019 Jul 13.
citation: Khan Q, Noor N, Anayat N, Khan TS, Ahmed M. Comparison Of Anaesthetic Efficacy Of Articaine And Lidocaine In Nonsurgical Endodontic Treatment Of Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis. A Randomized Clinical Trial. J Ayub Med Coll Abbottabad. 2021 Apr-Jun;33(2):192-197.