Pulpal AnesthesiaNCT01593930
Evaluation of the Success Rate of Pulpal Anesthesia in Mandibular First Molar Following Infiltration of 4% Articaine Alone and as Supplemental Injection After Inferior Alveolar Nerve Block
A study testing Lidocaine(IANB), 1 Articaine(Infiltration) and 2 Articaine(Infiltration) in people with Pulpal Anesthesia, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpal Anesthesia
- What is being tested?
- Lidocaine(IANB), 1 Articaine(Infiltration) and 2 Articaine(Infiltration)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Jan 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with at least 1 vital first mandibular molar without any restoration or decay
Who cannot join
- Patients with systemic conditions which eliminate the use of epinephrine
- Patients with history of allergy to amide anesthetics or contents of local anesthetic cartridge
- Pregnant women
- Use of analgesics, opioids or any other drugs which influence the anesthesia
Trial locations and contacts
1 site in 1 country.
Iran1 site
Zahedan university of medical sciences, Vice-chancellor for research
Zahedan
About this study
The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB).
Read the detailed description
According to inclusion \& exclusion criteria, volunteers will be selected and divided into 4 groups randomly. The clinician who does the injections will not be aware of study purpose. Also the person who does the electric pulp test (EPT); the volunteer and the statistical analyzer will not be aware of group codes. Intervention in each group will be as follow: Group 1-Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 2-Buccal infiltration of two 4% Articaine cartridges with 1/100000epinephrine. Group 3-Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 4- Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine. Before injection a control tooth (contralateral canine) will be tested to understand the accuracy of patient's response to EPT; also for measuring the base line vitality, each tooth will be evaluated by EPT twice before injection. After injection each tooth will be evaluated by EPT every 3 minutes; also every minute the anesthesia of lip and tongue will be checked, up to 15 minutes. The tooth will be discerned "anesthetized" if the subject will not response to 80 reading of EPT in 2 consecutive tests. Finally the information will be recorded and in addition to the success rate the mean time for onset of anesthesia and its mean duration time will be evaluated.
- Conditions
- Pulpal Anesthesia
- Being tested
- Lidocaine(IANB), 1 Articaine(Infiltration), 2 Articaine(Infiltration), Lidocaine(IANB)+1Articaine(Infiltration)
- Keywords
- Pulp Anesthesia, Articaine, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine(IANB)Other
Also called Persocaine E
Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
1 Articaine(Infiltration)Other
Also called Septanest
Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
2 Articaine(Infiltration)Other
Also called Septanest
Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
Lidocaine(IANB)+1Articaine(Infiltration)Other
Also called Persocaine E + Septanest
Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
| Study group | Role | What they receive |
|---|---|---|
| 1 Articaine(Infiltration) | Experimental | Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine Receives: Other: 1 Articaine(Infiltration) |
| 2 Articaine(Infiltration) | Experimental | Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine Receives: Other: 2 Articaine(Infiltration) |
| Lidocaine(IANB)+1Articaine(Infiltration) | Experimental | Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine Receives: Other: Lidocaine(IANB)+1Articaine(Infiltration) |
| Lidocaine(IANB) | Experimental | Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine Receives: Other: Lidocaine(IANB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. The anesthesia will be considered successful if the subject will not response to EPT at the 80 reading in 2 consecutive tests.
Measured: Every 3 minutes after injection
Secondary outcomes (2)
Onset of anesthesia
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. No response from the patient at the 80 reading of EPT in 2 consecutive tests will be discerned as "completely anesthetized" and the time will be recorded as "onset of anesthesia".
Measured: Every 3 minutes after injection
Duration of anesthesia
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after onset of anesthesia to determine when the subject will response again at the 80 reading of EPT.
Measured: Every 3 minutes after onset of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
- Investigators
- Kaveh Oloomi, DDS, MS, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593930
- Sponsor's protocol ID
- Articaine pulpal anesthesia
- Status last verified
- Jan 2013
- First submitted
- 4 May 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success Rate of Pulpal Anesthesia in Mandibular First Molar Following Infiltration of 4% Articaine Alone and as Supplemental Injection After Inferior Alveolar Nerve Block
- ClinicalTrials.gov ID
- NCT01593930
- Acronym / sponsor ID
- Articaine pulpal anesthesia
- Conditions
- Pulpal Anesthesia
- Keywords
- Pulp Anesthesia, Articaine, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 May 2012 (estimated)
- 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 purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB).
Detailed description
According to inclusion \& exclusion criteria, volunteers will be selected and divided into 4 groups randomly. The clinician who does the injections will not be aware of study purpose. Also the person who does the electric pulp test (EPT); the volunteer and the statistical analyzer will not be aware of group codes. Intervention in each group will be as follow: Group 1-Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 2-Buccal infiltration of two 4% Articaine cartridges with 1/100000epinephrine. Group 3-Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine. Group 4- Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine. Before injection a control tooth (contralateral canine) will be tested to understand the accuracy of patient's response to EPT; also for measuring the base line vitality, each tooth will be evaluated by EPT twice before injection. After injection each tooth will be evaluated by EPT every 3 minutes; also every minute the anesthesia of lip and tongue will be checked, up to 15 minutes. The tooth will be discerned "anesthetized" if the subject will not response to 80 reading of EPT in 2 consecutive tests. Finally the information will be recorded and in addition to the success rate the mean time for onset of anesthesia and its mean duration time will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Articaine(Infiltration) | Experimental | Other: 1 Articaine(Infiltration)Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine |
| 2 Articaine(Infiltration) | Experimental | Other: 2 Articaine(Infiltration)Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine |
| Lidocaine(IANB)+1Articaine(Infiltration) | Experimental | Other: Lidocaine(IANB)+1Articaine(Infiltration)Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine |
| Lidocaine(IANB) | Experimental | Other: Lidocaine(IANB)Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with at least 1 vital first mandibular molar without any restoration or decay
Key exclusion criteria (4 listed)
- Patients with systemic conditions which eliminate the use of epinephrine
- Patients with history of allergy to amide anesthetics or contents of local anesthetic cartridge
- Pregnant women
- Use of analgesics, opioids or any other drugs which influence the anesthesia
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 |
|---|---|---|
| Lidocaine(IANB)Also: Persocaine EInferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine | Other | Lidocaine(IANB) |
| 1 Articaine(Infiltration)Also: SeptanestBuccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine | Other | 1 Articaine(Infiltration) |
| 2 Articaine(Infiltration)Also: SeptanestBuccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine | Other | 2 Articaine(Infiltration) |
| Lidocaine(IANB)+1Articaine(Infiltration)Also: Persocaine E + SeptanestInferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine | Other | Lidocaine(IANB)+1Articaine(Infiltration) |
Primary outcome
Success rate
Time frame: Every 3 minutes after injection
Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. The anesthesia will be considered successful if the subject will not response to EPT at the 80 reading in 2 consecutive tests.
2 secondary outcomes
Onset of anesthesia
Time frame: Every 3 minutes after injection
Duration of anesthesia
Time frame: Every 3 minutes after onset of anesthesia
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 29 Jan 2013.
Related trials for Pulpal Anesthesia
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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.
Kaveh Oloomi, DDS, MS principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine(IANB), 1 Articaine(Infiltration) and 2 Articaine(Infiltration) in people with Pulpal Anesthesia, run by Zahedan 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 1 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: finished, as of the sponsor's last update on 29 Jan 2013. 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.
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?
Success rate (time frame: Every 3 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 29 Jan 2013.