Clinical trial NCT06276842: Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration
Official title: Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration for Mandibular Molars With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pulpitis
Keywords: Anesthesia
Inferior Alveolar Nerve
Infiltration
Lead sponsor: CIMS Dental College
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Dr Ayesha Ahmed
Study officials:
affiliation: CMH Multan Institute of Medical Sciences
name: Dil Rasheed, BDS,FCPS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.