Use of CBCT to Improve Inferior Alveolar Nerve Block Success

Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Inferior Alveolar Nerve; Mandibular Nerve Blocks
• Intervention / Treatment: Drug: 2% Lidocaine with 1:100,000 epinephrine

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Louisiana State University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBCT first; This 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 the implant is placed as a two-stage procedure, during the second stage implant uncovery will receive the standard injection technique. If the implant is placed as a one-stage procedure, the second visit will not apply.	Drug: 2% Lidocaine with 1:100,000 epinephrine; 2% Lidocaine with 1:100,000 epinephrine will be used for administering the lower jaw anesthesia (inferior alveolar nerve block).
Active Comparator: Standard technique first; This group will receive the standard injection technique first at the implant placement surgery and if the 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.	Drug: 2% Lidocaine with 1:100,000 epinephrine; 2% Lidocaine with 1:100,000 epinephrine will be used for administering the lower jaw anesthesia (inferior alveolar nerve block).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lingual nerve numbness	Numbness of tongue, numbness of lingual tissue	3 minutes
Lingual nerve numbness	Numbness of tongue, numbness of lingual tissue	5 minutes
Lingual nerve numbness	Numbness of tongue, numbness of lingual tissue	8 minutes
Lingual nerve numbness	Numbness of tongue, numbness of lingual tissue	10 minutes
Lingual nerve numbness	Numbness of tongue, numbness of lingual tissue	one hour
Lingual nerve numbness	Numbness of tongue, numbness of lingual tissue	2 hours
Mental nerve numbness	Numbness of lips, numbness of buccal gingival tissue of canine	3 minutes
Mental nerve numbness	Numbness of lips, numbness of buccal gingival tissue of canine	5 minutes
Mental nerve numbness	Numbness of lips, numbness of buccal gingival tissue of canine	8 minutes
Mental nerve numbness	Numbness of lips, numbness of buccal gingival tissue of canine	10 minutes
Mental nerve numbness	Numbness of lips, numbness of buccal gingival tissue of canine	1 hour
Mental nerve numbness	Numbness of lips, numbness of buccal gingival tissue of canine	2 hours
Inferior alveolar nerve numbness	Numbness of buccal gingival tissue of molar	3 minutes
Inferior alveolar nerve numbness	Numbness of buccal gingival tissue of molar	5 minutes
Inferior alveolar nerve numbness	Numbness of buccal gingival tissue of molar	8 minutes
Inferior alveolar nerve numbness	Numbness of buccal gingival tissue of molar	10 minutes
Inferior alveolar nerve numbness	Numbness of buccal gingival tissue of molar	1 hour
Inferior alveolar nerve numbness	Numbness of buccal gingival tissue of molar	2 hours
Inferior alveolar nerve numbness	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites	3 minutes
Inferior alveolar nerve numbness	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites	5 minutes
Inferior alveolar nerve numbness	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites	8 minutes
Inferior alveolar nerve numbness	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites	10 minutes
Inferior alveolar nerve numbness	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites	1 hour
Inferior alveolar nerve numbness	Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during surgery	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.	At the end of the procedure

Collaborators and Investigators

• Sponsor: Louisiana State University Health Sciences Center in New Orleans

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine
• Other Study ID Numbers: 2533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No