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

NCT ID: NCT06276842

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2020-09-30

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.

Detailed Description

Patients of Group A received Inferior Alveolar Nerve block anesthesia. For this block, nerve was approached from the contra-lateral side of the oral cavity over the contralateral premolars. Needle penetrated into the mandibular tissue on the average boundary of the mandibular ramus inside the pterygomandibular space and lateral to pterygomandibular fold, it advanced until bony surface was contacted. In the event that bony contact wasn't made inside 27-29 mm of needle infiltration, needle was pulled back somewhat, moved the needle further distally toward premolars. The needle was withdrew 1-2 mm after making bony contact, aspiration was performed, followed by 1.8 ml deposition of anesthetic solution.

Patients of Group B received buccal infiltration as supplementary injection technique to conventional Inferior Alveolar Nerve block, buccal infiltration was carried out. The needle was penetrated in buccal mucosa adjacent to mandibular 1st molar. After aspiration, 1.8ml of anesthetic solution was dumped in approximate time of 2 minutes using 2% lignocaine with 1:100,000 epinephrine. Following time period of 15 minutes of injection, every patient was inquired about his/her lip numbness. Patients who did not experience significant lip numbness within 15 minutes after the block was administered were excluded from the investigation and was considered ineffective. In case of positive lip numbness patient concerned teeth was isolated using rubber dam and a traditional access opening was started. Patient was told to lift hand if any pain will occur while doing procedure. The patient was requested to mark pain on visual analogue scale (VAS) after completion of treatment. Absence of pain was indicated if patient scored his/her pain ≤ 3 on VAS.

Conditions

Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient of Group A given Inferior Alveolar Nerve Block

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.

Group Type: EXPERIMENTAL

Inferior Alveolar Nerve Block

Intervention Type: DRUG

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

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

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.

Group Type: EXPERIMENTAL

Buccal Infiltration

Intervention Type: DRUG

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

Inferior Alveolar Nerve Block and Buccal Infiltration

Intervention Type: COMBINATION_PRODUCT

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

Interventions

Inferior Alveolar Nerve Block

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

Intervention Type: DRUG

Buccal Infiltration

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

Intervention Type: DRUG

Inferior Alveolar Nerve Block and Buccal Infiltration

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CIMS Dental College

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Ahmed

Demonstrator,Operative Dentistry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dil Rasheed, BDS,FCPS

Role: STUDY_DIRECTOR

CMH Multan Institute of Medical Sciences

Locations

Dr Ayesha Ahmed

Multan, , Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 30817070 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26149210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27558847 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27471808 (View on PubMed)

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id