Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration

NCT06276842 | Completed Phase 1

• 1 other identifier: 12345678
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis. STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020. MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block.

Conditions

Pulpitis

Keywords

Anesthesia; Inferior Alveolar Nerve; Infiltration

Outcome Measures

Primary Outcomes (1)

• Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone

  This investigation aims to assess the effectiveness of a combined technique involving an Inferior Alveolar Nerve block and buccal infiltration in providing supplementary anesthesia for the treatment of symptomatic irreversible pulpitis in the local population. The study will utilize quantitative measures to evaluate the number of participants experiencing successful anesthesia, measured by specific parameters such as pain relief scores. If demonstrated to be more effective than traditional methods, this technique may be recommended for routine clinical practice.

  6 months

Study Arms (2)

Patient of Group A given Inferior Alveolar Nerve Block

EXPERIMENTAL

The intervention involved approaching the nerve from the contralateral side of the oral cavity over the contralateral premolars. The needle was inserted into the mandibular tissue along the average boundary of the mandibular ramus within the pterygomandibular space and lateral to the pterygomandibular fold. If bony contact was not achieved within 27-29 mm of needle insertion, the needle was slightly withdrawn and repositioned more distally toward the premolars. After achieving bony contact, the needle was withdrawn by 1-2 mm, aspiration was performed, and then 1.8 ml of anesthetic solution was deposited.

Drug: Inferior Alveolar Nerve Block

Group B-buccal infiltration-supplementary injection technique to Inferior Alveolar Nerve block

EXPERIMENTAL

The intervention began by penetrating the needle into the buccal mucosa adjacent to the mandibular first molar. After aspiration, 1.8 ml of anesthetic solution (2% lignocaine with 1:100,000 epinephrine) was administered over approximately 2 minutes. Following a 15-minute period post-injection, each patient was asked about the level of numbness in their lip. Patients who did not experience significant lip numbness within this 15-minute timeframe were excluded from the study. For patients who reported positive lip numbness, the affected tooth was isolated using a rubber dam, and a traditional access opening procedure was initiated.

Drug: Buccal Infiltration; Combination Product: Inferior Alveolar Nerve Block and Buccal Infiltration

Interventions

Inferior Alveolar Nerve Block DRUG

Administration of a local anesthetic agent around the inferior alveolar nerve to achieve anesthesia in the mandibular region.

Patient of Group A given Inferior Alveolar Nerve Block

Buccal Infiltration DRUG

Administration of a local anesthetic agent into the tissue adjacent to the tooth being treated to achieve localized anesthesia.

Group B-buccal infiltration-supplementary injection technique to Inferior Alveolar Nerve block

Inferior Alveolar Nerve Block and Buccal Infiltration COMBINATION_PRODUCT

Utilization of both the Inferior Alveolar Nerve Block and Buccal Infiltration techniques simultaneously for anesthesia in the mandibular region.

Group B-buccal infiltration-supplementary injection technique to Inferior Alveolar Nerve block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mandibular molars with irreversible pulpitis (confirmed by positive response to EPT)
• Patient age between 18 to 45 years
• No medication taken 24 hours before treatment
• Both male and female patients

You may not qualify if:

• Patients on analgesics or anti-inflammatory drugs
• Medically compromised patients
• Teeth with immature apices
• Retreatment cases
• Patients allergic to lignocaine
• Teeth with root resorption
• Teeth with necrotic pulp
• Apical abscess
• Pregnancy

Sponsors & Collaborators

• CIMS Dental College: lead

Study Sites (1)

Dr Ayesha Ahmed

Multan, Pakistan

Location

Related Publications (4)

• Dougall A, Apperley O, Smith G, Madden L, Parkinson L, Daly B. Safety of buccal infiltration local anaesthesia for dental procedures. Haemophilia. 2019 Mar;25(2):270-275. doi: 10.1111/hae.13695. Epub 2019 Feb 28.

  PMID: 30817070 BACKGROUND

• Abazarpoor R, Parirokh M, Nakhaee N, Abbott PV. A Comparison of Different Volumes of Articaine for Inferior Alveolar Nerve Block for Molar Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2015 Sep;41(9):1408-11. doi: 10.1016/j.joen.2015.05.015. Epub 2015 Jul 3.

  PMID: 26149210 BACKGROUND

• Lin S, Wigler R, Huber R, Kaufman AY. Anaesthetic efficacy of intraligamentary injection techniques on mandibular molars diagnosed with asymptomatic irreversible pulpitis: A retrospective study. Aust Endod J. 2017 Apr;43(1):34-37. doi: 10.1111/aej.12169. Epub 2016 Aug 25.

  PMID: 27558847 BACKGROUND

• Chopra R, Marwaha M, Bansal K, Mittal M. Evaluation of Buccal Infiltration with Articaine and Inferior Alveolar Nerve Block with Lignocaine for Pulp Therapy in Mandibular Primary Molars. J Clin Pediatr Dent. 2016;40(4):301-5. doi: 10.17796/1053-4628-40.4.301.

  PMID: 27471808 RESULT

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dil Rasheed, BDS,FCPS

  CMH Multan Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator,Operative Dentistry Department

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: February 26, 2024
• Study Start: April 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)