Use of CBCT to Improve Inferior Alveolar Nerve Block Success

Not Applicable

Completed

• Conditions: Inferior Alveolar Nerve; Mandibular Nerve Blocks

• Registration Number: NCT05406895
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief Summary

The study looks to compare the success rate of lower jaw anesthesia injection (inferior alveolar nerve) that is guided by pre-treatment 3D dental scan (CBCT) versus standard injection technique.

Detailed Description

A total of 200 participants will be recruited that have existing 3D dental scans (CBCT) and require an implant placement (that will be placed in a two stage procedure) in the lower jaw for which a lower jaw anesthesia injection (inferior alveolar nerve) block will be used. The participants will be randomly assigned into one of two groups. The first group will receive the injection technique that is guided by pre-treatment measurements made from the 3D dental scan (CBCT) during implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. The second group will receive the standard injection technique first at the implant placement surgery and if implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the injection technique guided by the 3D dental scan (CBCT). If the implant is placed as a one-stage procedure, the second visit will not apply. Following this, subjective and objective measurements on the success of the anesthesia will be measured.

Study Timeline

• Study Start: 2022-05-25
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Male and female patients from the age 18 to 70 years old that are assigned to the 3 clinicians of the graduating class of LSUHSC School of Dentistry Post-graduate Periodontics program.
• Patients have been reported as an ASA I or ASA II patient that has never had an allergic reaction to lidocaine based on previous dental experience.
• The patient must be missing one or more mandibular teeth and is treatment planned for a mandibular implant that is placed that requires an inferior alveolar nerve block during surgery.
• Patient must have an existing CBCT scan within the last year or is planned for a CBCT scan for the purpose of dental implant treatment.

Exclusion Criteria

• The exclusion criteria include patients that have undergone long term use or continuous use within the last week of opioids, analgesics, medications of nerve related pathology and non-steroidal anti-inflammatory drugs.
• Patients diagnosed with trismus.
• Patients that request for Nitrous and IV anesthesia
• Patients missing remaining teeth in the quadrant or having a history of endodontic treatment of the remaining teeth in the quadrant.
• Patients having endodontic or pulpal pathology in the teeth in the quadrant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mental nerve numbness	2 hours	Numbness of lips, numbness of buccal gingival tissue of canine
Lingual nerve numbness	2 hours	Numbness of tongue, numbness of lingual tissue
Inferior alveolar nerve numbness	2 hours	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites

Secondary Outcome Measures

Name	Time	Method
Pain during surgery	At the end of the procedure	Pain during surgery will be measured using Visual Analog Scale (VAS) which is a linear scale from 0-100 with a lower number suggesting a more successful anesthesia.

Trial Locations

Locations (1)

Louisiana State University School of Dentistry; 🇺🇸 New Orleans, Louisiana, United States