Assessment of Local Anaesthesia Effectiveness in Symptomatic Irreversible Pulpitis

NCT ID: NCT06862570

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-19
• Study Completion Date: 2023-05-19

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.

Conditions

Symptomatic Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

2% LIGNOCAINE WITH EPINEPHRINE

1.8 ml of 2% Lignocaine with 1:100,000 epinephrine (36 mg/ml Lignocaine HCL, epinephrine bitartrate 0.0324 mg/ml)

Group Type: EXPERIMENTAL

2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

Intervention Type: DRUG

2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

4% ARTICAINE WITH EPINEPHRINE

1.7 ml of 4% Articaine with 1:100,000 epinephrine (40mg/ml Articaine HCL, epinephrine bitartrate 0.018mg/ml)

Group Type: EXPERIMENTAL

4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Intervention Type: DRUG

4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Interventions

2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

2% lignocaine with epinephrine 1.8 ml(36mg/ml lignocaine HCL, epinephrine bitartrate 0.0324mg/ml)

Intervention Type: DRUG

4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

4% Articaine with epinephrine 1.7 ml (40mg/ml Articaine HCL, epinephrine bitartrate 0.018 mg/ml)

Intervention Type: DRUG

Other Intervention Names

HD caine Plus; Orabloc

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

28 Military Dental Centre Lahore

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zahra Zubair

Dr Zahra Zubair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahra Zubair, BDS

Role: PRINCIPAL_INVESTIGATOR

28 Military Dental Centre

Locations

Zahra Zubir

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 29397214 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35656683 (View on PubMed)

Oghabi N, Renton T. Optimizing Local Anaesthetic Practice: Addressing Misconceptions and Minimizing Anaesthetic Failures. Dent Update. 2022;49(1):32-38.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 34274944 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31302768 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34137527 (View on PubMed)

Other Identifiers

LOCAL ANAESTHESIA

Identifier Type: -

Identifier Source: org_study_id