Inferior Alveolar Nerve InjuriesPhase 1NCT06564987
Risk of Nerve Damage After Administration of Local Anesthesia
A Phase 1 study testing 4% Articaine with 1:200,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine in people with Inferior Alveolar Nerve Injuries, run by Cleveland Dental Institute at 2 sites in United States.
Trial summary
This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Injuries
- What is being tested?
- 4% Articaine with 1:200,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2024to 31 Mar 2025
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with age between 18-55 years old
- Patients need IANB
- healthy patient
Who cannot join
- medical conditions
- allergies
- medications
- pregnancy and breastfeeding
- inability to provide informed consent
- specific dental or medical history.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Recruiting
Cleveland Dental Institute
Akron, Ohio, 44703
Waleed Elmallah, PhD, 216-333-6695, w.elmallah@cdiohio.org
Ahmed A Hashem, PhD, 4405021591, a.hashem@cdiohio.org
- Active, not recruiting
Cleveland Dental Institute
Ashtabula, Ohio, 44004
About this study
Official title: Risk of Nerve Damage After Administration of an Inferior Alveolar Nerve Block Using 4% Articaine Versus 2% Lidocaine
This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. The type of LA will be concealed to the operator, investigators and assessors. The patients will be monitored for any aigns of nerve parathesia for 3 months after the procedure.
- Conditions
- Inferior Alveolar Nerve Injuries
- Being tested
- 4% Articaine with 1:200,000 epinephrine, 2% lidocaine with 1:100,000 epinephrine
- Medical subject headings
- Mandibular Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% Articaine with 1:200,000 epinephrineDrug
Inferior Alveolar Nerve Block with 4% articaine
2% lidocaine with 1:100,000 epinephrineDrug
Inferior Alveolar Nerve Block with 2% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Articaine | Experimental | Inferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic Receives: Drug: 4% Articaine with 1:200,000 epinephrine |
| Lidocaine | Active comparator | Inferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic 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.
Electromyograph
Signs of loss of sensation in the involved side of the jaw will be recorded using a tool called Electromyograph machine to evaluate and record Nerve conduction velocity, the scale is as follow Normal (grade 0) to extremely damage of (grade 6) while a patient rate pain intensity on a Visual Analogue Scale (VAS).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve InjuriesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cleveland Dental Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed A Hashem, PhD, Study director, Cleveland Dental InstituteWaleed Elmallah, PhD, Principal investigator, Cleveland Dental Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564987
- Sponsor's protocol ID
- CDIOS0005
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks. J Am Dent Assoc. 2000 Jul;131(7):901-7. doi: 10.14219/jada.archive.2000.0308.
PubMed 10916328Mikesell P, Nusstein J, Reader A, Beck M, Weaver J. A comparison of articaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Apr;31(4):265-70. doi: 10.1097/01.don.0000140576.36513.cb.
PubMed 15793381Katyal V. The efficacy and safety of articaine versus lignocaine in dental treatments: a meta-analysis. J Dent. 2010 Apr;38(4):307-17. doi: 10.1016/j.jdent.2009.12.003. Epub 2009 Dec 16.
PubMed 20006669Stirrup P, Crean S. Does articaine, rather than lidocaine, increase the risk of nerve damage when administered for inferior alveolar nerve blocks in patients undergoing local anaesthesia for dental treatment? A mini systematic review of the literature. Br Dent J. 2019 Feb 8;226(3):213-223. doi: 10.1038/sj.bdj.2019.98.
PubMed 30734772Hook H. Inferior alveolar nerve block: is articaine better than lidocaine? Br Dent J. 2021 May;230(9):579-582. doi: 10.1038/s41415-021-2941-z. Epub 2021 May 14.
PubMed 33990740Samdrup T, Kijsamanmith K, Vongsavan K, Rirattanapong P, Vongsavan N. The effect of inferior alveolar nerve block anesthesia of 4% articaine and epinephrine 1:100,000 on blood flow and anesthesia of human mandibular teeth. J Dent Sci. 2021 Jan;16(1):249-255. doi: 10.1016/j.jds.2020.05.013. Epub 2020 Jun 4.
PubMed 33384805Aquilanti L, Mascitti M, Togni L, Contaldo M, Rappelli G, Santarelli A. A Systematic Review on Nerve-Related Adverse Effects following Mandibular Nerve Block Anesthesia. Int J Environ Res Public Health. 2022 Jan 31;19(3):1627. doi: 10.3390/ijerph19031627.
PubMed 35162650
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Nerve Damage After Administration of an Inferior Alveolar Nerve Block Using 4% Articaine Versus 2% Lidocaine
- ClinicalTrials.gov ID
- NCT06564987
- Acronym / sponsor ID
- CDIOS0005
- Conditions
- Inferior Alveolar Nerve Injuries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cleveland Dental InstituteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
This research aims to evaluate of the risk of nerve damage following the administration of articaine 4% and lidocaine 2% for Inferior Alveolar nerve Block (IANB). A Randomized Controlled Clinical Trial will be conducted where the patient will be randomly assigned to one the two groups; articaine 4% and Lidocaine 2%. The type of LA will be concealed to the operator, investigators and assessors. The patients will be monitored for any aigns of nerve parathesia for 3 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Articaine | Experimental | Drug: 4% Articaine with 1:200,000 epinephrineInferior Alveolar Nerve block using Articaine 4% with 1:200,000 epinephrine local anesthetic |
| Lidocaine | Active comparator | Drug: 2% lidocaine with 1:100,000 epinephrineInferior Alveolar Nerve block using 2% lidocaine with 1:100,000 epinephrine local anesthetic |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with age between 18-55 years old
- Patients need IANB
- healthy patient
Key exclusion criteria (6 listed)
- medical conditions
- allergies
- medications
- pregnancy and breastfeeding
- inability to provide informed consent
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 |
|---|---|---|
| 4% Articaine with 1:200,000 epinephrineInferior Alveolar Nerve Block with 4% articaine | Drug | Articaine |
| 2% lidocaine with 1:100,000 epinephrineInferior Alveolar Nerve Block with 2% lidocaine | Drug | Lidocaine |
Primary outcome
Electromyograph
Time frame: 3 months
Signs of loss of sensation in the involved side of the jaw will be recorded using a tool called Electromyograph machine to evaluate and record Nerve conduction velocity, the scale is as follow Normal (grade 0) to extremely damage of (grade 6) while a patient rate pain intensity on a Visual Analogue Scale (VAS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Results publication: PubMed 10916328Pogrel MA, Thamby S. Permanent nerve involvement resulting from inferior alveolar nerve blocks. J Am Dent Assoc. 2000 Jul;131(7):901-7. doi: 10.14219/jada.archive.2000.0308.
- Results publication: PubMed 15793381Mikesell P, Nusstein J, Reader A, Beck M, Weaver J. A comparison of articaine and lidocaine for inferior alveolar nerve blocks. J Endod. 2005 Apr;31(4):265-70. doi: 10.1097/01.don.0000140576.36513.cb.
- Results publication: PubMed 20006669Katyal V. The efficacy and safety of articaine versus lignocaine in dental treatments: a meta-analysis. J Dent. 2010 Apr;38(4):307-17. doi: 10.1016/j.jdent.2009.12.003. Epub 2009 Dec 16.
- Results publication: PubMed 30734772Stirrup P, Crean S. Does articaine, rather than lidocaine, increase the risk of nerve damage when administered for inferior alveolar nerve blocks in patients undergoing local anaesthesia for dental treatment? A mini systematic review of the literature. Br Dent J. 2019 Feb 8;226(3):213-223. doi: 10.1038/sj.bdj.2019.98.
- Results publication: PubMed 33990740Hook H. Inferior alveolar nerve block: is articaine better than lidocaine? Br Dent J. 2021 May;230(9):579-582. doi: 10.1038/s41415-021-2941-z. Epub 2021 May 14.
- Results publication: PubMed 33384805Samdrup T, Kijsamanmith K, Vongsavan K, Rirattanapong P, Vongsavan N. The effect of inferior alveolar nerve block anesthesia of 4% articaine and epinephrine 1:100,000 on blood flow and anesthesia of human mandibular teeth. J Dent Sci. 2021 Jan;16(1):249-255. doi: 10.1016/j.jds.2020.05.013. Epub 2020 Jun 4.
- Results publication: PubMed 35162650Aquilanti L, Mascitti M, Togni L, Contaldo M, Rappelli G, Santarelli A. A Systematic Review on Nerve-Related Adverse Effects following Mandibular Nerve Block Anesthesia. Int J Environ Res Public Health. 2022 Jan 31;19(3):1627. doi: 10.3390/ijerph19031627.
- Individual participant dataSharing planned: No
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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.
Ahmed A Hashem, PhD study director
Cleveland Dental Institute
Waleed Elmallah, PhD principal investigator
Cleveland Dental Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 4% Articaine with 1:200,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine in people with Inferior Alveolar Nerve Injuries, run by Cleveland Dental Institute at 2 sites 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo R Velazquez, Resident (7546108595, p.velazquez@cdiohio.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyograph (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06564987, which also lists 7 linked publications.
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 26 Aug 2024.