Clinical trial NCT05406895: Use of CBCT to Improve Inferior Alveolar Nerve Block Success
Official title: Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inferior Alveolar Nerve
Mandibular Nerve Blocks
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel model for either CBCT guided or intra-oral technique. If the patients receive a two-stage implant placement technique then a cross-over model will be used.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lingual nerve numbness
timeFrame: 3 minutes
measure: Lingual nerve numbness
timeFrame: 5 minutes
measure: Lingual nerve numbness
timeFrame: 8 minutes
measure: Lingual nerve numbness
timeFrame: 10 minutes
measure: Lingual nerve numbness
timeFrame: one hour
measure: Lingual nerve numbness
timeFrame: 2 hours
measure: Mental nerve numbness
timeFrame: 3 minutes
measure: Mental nerve numbness
timeFrame: 5 minutes
measure: Mental nerve numbness
timeFrame: 8 minutes
measure: Mental nerve numbness
timeFrame: 10 minutes
measure: Mental nerve numbness
timeFrame: 1 hour
measure: Mental nerve numbness
timeFrame: 2 hours
measure: Inferior alveolar nerve numbness
timeFrame: 3 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 5 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 8 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 10 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 1 hour
measure: Inferior alveolar nerve numbness
timeFrame: 2 hours
measure: Inferior alveolar nerve numbness
timeFrame: 3 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 5 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 8 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 10 minutes
measure: Inferior alveolar nerve numbness
timeFrame: 1 hour
measure: Inferior alveolar nerve numbness
timeFrame: 2 hours
Secondary outcomes:
measure: Pain during surgery
timeFrame: At the end of the procedure
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University School of Dentistry
state: Louisiana
Study officials:
References: