Inferior Alveolar NerveNCT05406895
Use of CBCT to Improve Inferior Alveolar Nerve Block Success
A study testing 2% Lidocaine with 1:100,000 epinephrine in people with Inferior Alveolar Nerve and Mandibular Nerve Blocks, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve, Mandibular Nerve Blocks
- What is being tested?
- 2% Lidocaine with 1:100,000 epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University School of Dentistry
New Orleans, Louisiana, 70119
About this study
Official title: 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.
Read the 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.
- Conditions
- Inferior Alveolar Nerve, Mandibular Nerve Blocks
- Being tested
- 2% Lidocaine with 1:100,000 epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Lidocaine with 1:100,000 epinephrineDrug
2% Lidocaine with 1:100,000 epinephrine will be used for administering the lower jaw anesthesia (inferior alveolar nerve block).
| Study group | Role | What they receive |
|---|---|---|
| CBCT first | Experimental | 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. Receives: Drug: 2% Lidocaine with 1:100,000 epinephrine |
| Standard technique first | Active comparator | 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. Receives: Drug: 2% Lidocaine with 1:100,000 epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lingual nerve numbness
Numbness of tongue, numbness of lingual tissue
Measured: 3 minutes
Lingual nerve numbness
Numbness of tongue, numbness of lingual tissue
Measured: 5 minutes
Lingual nerve numbness
Numbness of tongue, numbness of lingual tissue
Measured: 8 minutes
Lingual nerve numbness
Numbness of tongue, numbness of lingual tissue
Measured: 10 minutes
Lingual nerve numbness
Numbness of tongue, numbness of lingual tissue
Measured: one hour
Lingual nerve numbness
Numbness of tongue, numbness of lingual tissue
Measured: 2 hours
Mental nerve numbness
Numbness of lips, numbness of buccal gingival tissue of canine
Measured: 3 minutes
Mental nerve numbness
Numbness of lips, numbness of buccal gingival tissue of canine
Measured: 5 minutes
Mental nerve numbness
Numbness of lips, numbness of buccal gingival tissue of canine
Measured: 8 minutes
Mental nerve numbness
Numbness of lips, numbness of buccal gingival tissue of canine
Measured: 10 minutes
Mental nerve numbness
Numbness of lips, numbness of buccal gingival tissue of canine
Measured: 1 hour
Mental nerve numbness
Numbness of lips, numbness of buccal gingival tissue of canine
Measured: 2 hours
Inferior alveolar nerve numbness
Numbness of buccal gingival tissue of molar
Measured: 3 minutes
Inferior alveolar nerve numbness
Numbness of buccal gingival tissue of molar
Measured: 5 minutes
Inferior alveolar nerve numbness
Numbness of buccal gingival tissue of molar
Measured: 8 minutes
Inferior alveolar nerve numbness
Numbness of buccal gingival tissue of molar
Measured: 10 minutes
Inferior alveolar nerve numbness
Numbness of buccal gingival tissue of molar
Measured: 1 hour
Inferior alveolar nerve numbness
Numbness of buccal gingival tissue of molar
Measured: 2 hours
Inferior alveolar nerve numbness
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Measured: 3 minutes
Inferior alveolar nerve numbness
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Measured: 5 minutes
Inferior alveolar nerve numbness
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Measured: 8 minutes
Inferior alveolar nerve numbness
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Measured: 10 minutes
Inferior alveolar nerve numbness
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Measured: 1 hour
Inferior alveolar nerve numbness
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Measured: 2 hours
Secondary outcomes (1)
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.
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start25 May 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Alveolar NerveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406895
- Sponsor's protocol ID
- 2533
- Status last verified
- May 2024
- First submitted
- 27 May 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of CBCT Pre-operative Measurements Improve the Success Rate of Inferior Alveolar Nerve Block? - A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05406895
- Acronym / sponsor ID
- 2533
- Conditions
- Inferior Alveolar Nerve, Mandibular Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CBCT first | Experimental | Drug: 2% Lidocaine with 1:100,000 epinephrineThis 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. |
| Standard technique first | Active comparator | Drug: 2% Lidocaine with 1:100,000 epinephrineThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Lidocaine with 1:100,000 epinephrine2% Lidocaine with 1:100,000 epinephrine will be used for administering the lower jaw anesthesia (inferior alveolar nerve block). | Drug | CBCT first, Standard technique first |
Primary outcome
Lingual nerve numbness
Time frame: 3 minutes
Numbness of tongue, numbness of lingual tissue
Lingual nerve numbness
Time frame: 5 minutes
Numbness of tongue, numbness of lingual tissue
Lingual nerve numbness
Time frame: 8 minutes
Numbness of tongue, numbness of lingual tissue
Lingual nerve numbness
Time frame: 10 minutes
Numbness of tongue, numbness of lingual tissue
Lingual nerve numbness
Time frame: one hour
Numbness of tongue, numbness of lingual tissue
Lingual nerve numbness
Time frame: 2 hours
Numbness of tongue, numbness of lingual tissue
Mental nerve numbness
Time frame: 3 minutes
Numbness of lips, numbness of buccal gingival tissue of canine
Mental nerve numbness
Time frame: 5 minutes
Numbness of lips, numbness of buccal gingival tissue of canine
Mental nerve numbness
Time frame: 8 minutes
Numbness of lips, numbness of buccal gingival tissue of canine
Mental nerve numbness
Time frame: 10 minutes
Numbness of lips, numbness of buccal gingival tissue of canine
Mental nerve numbness
Time frame: 1 hour
Numbness of lips, numbness of buccal gingival tissue of canine
Mental nerve numbness
Time frame: 2 hours
Numbness of lips, numbness of buccal gingival tissue of canine
Inferior alveolar nerve numbness
Time frame: 3 minutes
Numbness of buccal gingival tissue of molar
Inferior alveolar nerve numbness
Time frame: 5 minutes
Numbness of buccal gingival tissue of molar
Inferior alveolar nerve numbness
Time frame: 8 minutes
Numbness of buccal gingival tissue of molar
Inferior alveolar nerve numbness
Time frame: 10 minutes
Numbness of buccal gingival tissue of molar
Inferior alveolar nerve numbness
Time frame: 1 hour
Numbness of buccal gingival tissue of molar
Inferior alveolar nerve numbness
Time frame: 2 hours
Numbness of buccal gingival tissue of molar
Inferior alveolar nerve numbness
Time frame: 3 minutes
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Inferior alveolar nerve numbness
Time frame: 5 minutes
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Inferior alveolar nerve numbness
Time frame: 8 minutes
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Inferior alveolar nerve numbness
Time frame: 10 minutes
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Inferior alveolar nerve numbness
Time frame: 1 hour
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
Inferior alveolar nerve numbness
Time frame: 2 hours
Cold endodontic test at 1st molar, 2nd molar, 1st premolar and 2nd premolar sites
1 secondary outcome
Pain during surgery
Time frame: At the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
Related trials for Inferior Alveolar Nerve
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Not yet recruiting
Effect of the CALAJECT System on Pain Perception, Heart Rate, and Blood Pressure During Inferior Alveolar Nerve Block: A Randomized Controlled Clinical Trial
Local Anesthesia in Dentistry
Recruiting
Comparison of Anesthetic Efficacy OF 2% Lidocaine Inferior Alveolar Nerve (IANB) Block Versus Primary Buccal Infilteration With 4% Articaine in Symptomatic Irreversible Pulpitis(SIP) IN Mandibular First Molars
Anesthetic Efficacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% Lidocaine with 1:100,000 epinephrine in people with Inferior Alveolar Nerve and Mandibular Nerve Blocks, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lingual nerve numbness (time frame: 3 minutes). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.