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

Pulpitis Clinical Trial

Official title:

Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration for Mandibular Molars With Irreversible Pulpitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06276842
• Other study ID #: 12345678
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2024
• Source: CIMS Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpitis

Intervention

Drug:
• Inferior Alveolar Nerve Block
Administration of a local anesthetic agent around the inferior alveolar nerve to achieve anesthesia in the mandibular region.
• Buccal Infiltration
Administration of a local anesthetic agent into the tissue adjacent to the tooth being treated to achieve localized anesthesia.

Combination Product:
• 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.

Locations

Country	Name	City	State
Pakistan	Dr Ayesha Ahmed	Multan

Sponsors (1)

Lead Sponsor	Collaborator
CIMS Dental College

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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