Inferior Alveolar Nerve BlockNTALJNCT04093713
A Novel Technique to Anaesthetize the Lower Jaw
A study testing A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin in people with Inferior Alveolar Nerve Block, run by Mosaad Khalifah at 1 site in Egypt.
Trial summary
This study introduces and evaluates a new technique for inferior alveolar nerve blocking. Read more about this study
- Who is it for?
- Ages 5 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Block
- What is being tested?
- A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2019to 16 Sep 2019
- 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 5 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- fitness for nerve block local anaesthesia physically and psychologically
Who cannot join
- any disease or condition obstacles nerve block local anaesthesia administration such as hemophilia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inferior Alveolar Nerve Block: a Novel Intraoral Technique Depends on Extraoral Landmarks
This study introduces and evaluates a new technique for inferior alveolar nerve blocking.
Read the detailed description
The study addresses a novel technique to anaesthetize the inferior alveolar nerve depending on extraoral landmarks. Volunteers will receive bilateral blocks and evaluation of the success rate and positive aspiration rate will be performed.
- Conditions
- Inferior Alveolar Nerve Block
- Being tested
- A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin
- Keywords
- Anaesthesia, Technique, extraoral, Landmarks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A novel technique to block the inferior alveolar nerve block using Mepivecaine with LevonordefrinProcedure or surgery
blocking the inferior alveolar nerve using extroral landmarks
| Study group | Role | What they receive |
|---|---|---|
| participants | Other | participants are subjected to a novel technique to block the inferior alveolar nerve depending on extraoral landmarks Receives: Procedure: A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of numbness (by questionnaire)
evaluation of the presence of numbness in the anatomical area supplied by the inferior alveolar nerve
Measured: 3-10 minutes
absence of pain (by probing)
evaluation of absence of pain in the anatomical area supplied by the inferior alveolar nerve
Measured: 3-10 minutes
Secondary outcomes (1)
positive aspiration rate
evaluation of the presence of blood on drawing in two perpendicular planes
Measured: 1 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start14 Sep 2019 (estimated)
- Primary completion16 Sep 2019 (estimated)
- Study completion16 Sep 2019 (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 BlockStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mosaad Khalifah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mosaad Khalifah, Hosh Isa Medical Center
- Investigators
- Mosaad A Khalifah, DDSc, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093713
- Sponsor's protocol ID
- Surg192
- Acronym
- NTALJ
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No other researchers are involved in the study
Publications
Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.
PubMed 19228214Donkor P, Wong J, Punnia-Moorthy A. An evaluation of the closed mouth mandibular block technique. Int J Oral Maxillofac Surg. 1990 Aug;19(4):216-9. doi: 10.1016/s0901-5027(05)80395-9.
PubMed 2120362Montagnese TA, Reader A, Melfi R. A comparative study of the Gow-Gates technique and a standard technique for mandibular anesthesia. J Endod. 1984 Apr;10(4):158-63. doi: 10.1016/S0099-2399(84)80120-X. No abstract available.
PubMed 6586971McLean C, Reader A, Beck M, Meryers WJ. An evaluation of 4% prilocaine and 3% mepivacaine compared with 2% lidocaine (1:100,000 epinephrine) for inferior alveolar nerve block. J Endod. 1993 Mar;19(3):146-50. doi: 10.1016/s0099-2399(06)80510-8.
PubMed 8509754Akinosi JO. A new approach to the mandibular nerve block. Br J Oral Surg. 1977 Jul;15(1):83-7. doi: 10.1016/0007-117x(77)90011-7.
PubMed 268212Boonsiriseth K, Sirintawat N, Arunakul K, Wongsirichat N. Comparative study of the novel and conventional injection approach for inferior alveolar nerve block. Int J Oral Maxillofac Surg. 2013 Jul;42(7):852-6. doi: 10.1016/j.ijom.2012.11.017. Epub 2012 Dec 21.
PubMed 23265758Suazo Galdames IC, Cantin Lopez MG, Zavando Matamala DA. Inferior alveolar nerve block anesthesia via the retromolar triangle, an alternative for patients with blood dyscrasias. Med Oral Patol Oral Cir Bucal. 2008 Jan 1;13(1):E43-7.
PubMed 18167480
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inferior Alveolar Nerve Block: a Novel Intraoral Technique Depends on Extraoral Landmarks
- ClinicalTrials.gov ID
- NCT04093713
- Acronym / sponsor ID
- NTALJ / Surg192
- Conditions
- Inferior Alveolar Nerve Block
- Keywords
- Anaesthesia, Technique, extraoral, Landmarks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Mosaad KhalifahUniversity, hospital or other
- Study start
- 14 Sep 2019 (estimated)
- Primary completion
- 16 Sep 2019 (estimated)
- Study completion
- 16 Sep 2019 (estimated)
- First posted
- 18 Sep 2019 (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 study introduces and evaluates a new technique for inferior alveolar nerve blocking.
Detailed description
The study addresses a novel technique to anaesthetize the inferior alveolar nerve depending on extraoral landmarks. Volunteers will receive bilateral blocks and evaluation of the success rate and positive aspiration rate will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | Other | Procedure: A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrinparticipants are subjected to a novel technique to block the inferior alveolar nerve depending on extraoral landmarks |
Who may qualify
- Ages
- 5 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- fitness for nerve block local anaesthesia physically and psychologically
Key exclusion criteria (1 listed)
- any disease or condition obstacles nerve block local anaesthesia administration such as hemophilia.
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 |
|---|---|---|
| A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrinblocking the inferior alveolar nerve using extroral landmarks | Procedure or surgery | participants |
Primary outcome
presence of numbness (by questionnaire)
Time frame: 3-10 minutes
evaluation of the presence of numbness in the anatomical area supplied by the inferior alveolar nerve
absence of pain (by probing)
Time frame: 3-10 minutes
evaluation of absence of pain in the anatomical area supplied by the inferior alveolar nerve
1 secondary outcome
positive aspiration rate
Time frame: 1 second
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Background: PubMed 19228214Kanaa MD, Whitworth JM, Corbett IP, Meechan JG. Articaine buccal infiltration enhances the effectiveness of lidocaine inferior alveolar nerve block. Int Endod J. 2009 Mar;42(3):238-46. doi: 10.1111/j.1365-2591.2008.01507.x.
- Background: PubMed 2120362Donkor P, Wong J, Punnia-Moorthy A. An evaluation of the closed mouth mandibular block technique. Int J Oral Maxillofac Surg. 1990 Aug;19(4):216-9. doi: 10.1016/s0901-5027(05)80395-9.
- Background: PubMed 6586971Montagnese TA, Reader A, Melfi R. A comparative study of the Gow-Gates technique and a standard technique for mandibular anesthesia. J Endod. 1984 Apr;10(4):158-63. doi: 10.1016/S0099-2399(84)80120-X. No abstract available.
- Background: PubMed 8509754McLean C, Reader A, Beck M, Meryers WJ. An evaluation of 4% prilocaine and 3% mepivacaine compared with 2% lidocaine (1:100,000 epinephrine) for inferior alveolar nerve block. J Endod. 1993 Mar;19(3):146-50. doi: 10.1016/s0099-2399(06)80510-8.
- Background: PubMed 268212Akinosi JO. A new approach to the mandibular nerve block. Br J Oral Surg. 1977 Jul;15(1):83-7. doi: 10.1016/0007-117x(77)90011-7.
- Background: PubMed 23265758Boonsiriseth K, Sirintawat N, Arunakul K, Wongsirichat N. Comparative study of the novel and conventional injection approach for inferior alveolar nerve block. Int J Oral Maxillofac Surg. 2013 Jul;42(7):852-6. doi: 10.1016/j.ijom.2012.11.017. Epub 2012 Dec 21.
- Background: PubMed 18167480Suazo Galdames IC, Cantin Lopez MG, Zavando Matamala DA. Inferior alveolar nerve block anesthesia via the retromolar triangle, an alternative for patients with blood dyscrasias. Med Oral Patol Oral Cir Bucal. 2008 Jan 1;13(1):E43-7.
- Individual participant dataSharing planned: No. No other researchers are involved in the study
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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.
Mosaad A Khalifah, DDSc principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin in people with Inferior Alveolar Nerve Block, run by Mosaad Khalifah at 1 site in Egypt.
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 1 inclusion and 1 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 18 Sep 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mosaad A Khalifah, DDSc (00201008603084, mosaad78@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of numbness (by questionnaire) (time frame: 3-10 minutes). The study lists 2 primary outcomes in all. 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 NCT04093713, 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 18 Sep 2019.