Use of CBCT to Improve Inferior Alveolar Nerve Block Success

Inferior Alveolar Nerve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406895
• Other study ID #: 2533
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2024
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inferior Alveolar Nerve

Intervention

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).

Locations

Country	Name	City	State
United States	Louisiana State University School of Dentistry	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

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