AnesthesiaPhase 2/3NCT03786211
IANB Success Rate With and Without Panoramic Help
A Phase 2/3 study testing IANB by the guide of Panoramic and IANB without the guide of Panoramic in people with Anesthesia and Anesthesia; Functional, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low and there are a lot of anatomic variations for the location of inferior alveolar nerve in different races, investigators decided to compare the success rate of inferior alveolar nerve block, with and without using a panoramic… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia; Functional
- What is being tested?
- IANB by the guide of Panoramic and IANB without the guide of Panoramic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 12 Nov 2018to Feb 2019
- Phase
- Phase 2/3
- 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
- Patients indicated for bilateral tooth extractions of fillings.
- Physically and mentally healthy patients who could express their pain.
- having panoramic radiograph from the past six months for other dental purposes.
Who cannot join
- sensitive to the regular anesthetics containing epinephrine.
- patients with acute or chronic pericoronitis.
- pregnancy
- trismus
Trial locations and contacts
1 site in 1 country.
Hossein Dabbagh contact
Iran1 site, 1 recruiting
- Recruiting
Dental clinic of BandarAbbas faculty of dentistry
BandarAbbas, Hormozgan
Hossein Dabbagh, Md, PhD, hossein.dabagh@hums.ac.ir
About this study
Official title: The Success of the Inferior Alveolar Nerve Block Anesthesia With Alveolar Nerve Localization by Using of Panoramic Radiography in Comparison to Routine IAN Block Anesthesia: RCT
Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low and there are a lot of anatomic variations for the location of inferior alveolar nerve in different races, investigators decided to compare the success rate of inferior alveolar nerve block, with and without using a panoramic radiograph in Bandar Abbas population, and see if using a panoramic radiograph can increase the preciseness of the injection.
Read the detailed description
This is a double blinded cross-over randomized controlled trial study conducted on all the patients of the dental clinic indicated for bilateral extraction or filling.
The randomization method is block balanced randomization. All patients will ask to fulfill the ethical Form. This form acquired demographic information (e.g. age, sex) about patients. A panoramic radiograph will take from those who matched the inclusion criteria and signed the agreement. Then a tooth from one side will be treated and the tooth from the other side of the mouth will treat at least 2 weeks later by the same dentist.
- Conditions
- Anesthesia, Anesthesia; Functional
- Being tested
- IANB by the guide of Panoramic, IANB without the guide of Panoramic
- Keywords
- Mandible, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IANB by the guide of PanoramicProcedure or surgery
IANB will be injected by the guide of panoramic radiograph
IANB without the guide of PanoramicProcedure or surgery
IANB will be injected without the guide of panoramic radiograph, in the routine way.
| Study group | Role | What they receive |
|---|---|---|
| IANB without panoramic | Active comparator | They will get Ianb without using panoramic Receives: Procedure: IANB by the guide of Panoramic; Procedure: IANB without the guide of Panoramic |
| IANB with panoramic | Experimental | They will get IANB by the guide of panoramic Receives: Procedure: IANB by the guide of Panoramic; Procedure: IANB without the guide of Panoramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with good Anesthesia
Measured: 30 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start12 Nov 2018
- Primary completionJan 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sajad Ansari Fard, Hormozgan University of Medical Sciences
- Investigators
- Hossein Dabbagh, Md, PhD, Study chair, Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786211
- Sponsor's protocol ID
- HMS 50126
- Status last verified
- Dec 2018
- First submitted
- 8 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success of the Inferior Alveolar Nerve Block Anesthesia With Alveolar Nerve Localization by Using of Panoramic Radiography in Comparison to Routine IAN Block Anesthesia: RCT
- ClinicalTrials.gov ID
- NCT03786211
- Acronym / sponsor ID
- HMS 50126
- Conditions
- Anesthesia, Anesthesia; Functional
- Keywords
- Mandible, Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 24 Dec 2018 (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.
Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low and there are a lot of anatomic variations for the location of inferior alveolar nerve in different races, investigators decided to compare the success rate of inferior alveolar nerve block, with and without using a panoramic radiograph in Bandar Abbas population, and see if using a panoramic radiograph can increase the preciseness of the injection.
Detailed description
This is a double blinded cross-over randomized controlled trial study conducted on all the patients of the dental clinic indicated for bilateral extraction or filling.
The randomization method is block balanced randomization. All patients will ask to fulfill the ethical Form. This form acquired demographic information (e.g. age, sex) about patients. A panoramic radiograph will take from those who matched the inclusion criteria and signed the agreement. Then a tooth from one side will be treated and the tooth from the other side of the mouth will treat at least 2 weeks later by the same dentist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IANB without panoramic | Active comparator | Procedure: IANB by the guide of Panoramic, Procedure: IANB without the guide of PanoramicThey will get Ianb without using panoramic |
| IANB with panoramic | Experimental | Procedure: IANB by the guide of Panoramic, Procedure: IANB without the guide of PanoramicThey will get IANB by the guide of panoramic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients indicated for bilateral tooth extractions of fillings.
- Physically and mentally healthy patients who could express their pain.
- having panoramic radiograph from the past six months for other dental purposes.
Key exclusion criteria (4 listed)
- sensitive to the regular anesthetics containing epinephrine.
- patients with acute or chronic pericoronitis.
- pregnancy
- trismus
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 |
|---|---|---|
| IANB by the guide of PanoramicIANB will be injected by the guide of panoramic radiograph | Procedure or surgery | IANB with panoramic, IANB without panoramic |
| IANB without the guide of PanoramicIANB will be injected without the guide of panoramic radiograph, in the routine way. | Procedure or surgery | IANB with panoramic, IANB without panoramic |
Primary outcome
Number of participants with good Anesthesia
Time frame: 30 minutes after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: Yes
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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.
Hossein Dabbagh contact
Hossein Dabbagh, Md, PhD study chair
Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IANB by the guide of Panoramic and IANB without the guide of Panoramic in people with Anesthesia and Anesthesia; Functional, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 4 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 24 Dec 2018. 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 Iran. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sajad Ansarifard, DDS, PhD (?989366584476, Sajad.ansarifard@hums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with good Anesthesia (time frame: 30 minutes after injection). 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 24 Dec 2018.