Local AnesthesiaPhase 2/3IANBNCT03531970
Effect of Lidocaine/Dexamethasone on the Success of IANB
A Phase 2/3 study testing 2% lidocaine with 1:80,000 epinephrine and Dexamethasone in people with Local Anesthesia, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- 2% lidocaine with 1:80,000 epinephrine and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 1 Aug 2016to 1 Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Who cannot join
- younger than 18 years old
- history of significant medical conditions
- allergies to local anesthetics or sulfites
- pregnancy
- taking any medications that might influence anesthetic assessment
- active sites of pathosis in area of injection
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis
The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
Read the detailed description
Several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. These investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. It is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block
- Conditions
- Local Anesthesia
- Being tested
- 2% lidocaine with 1:80,000 epinephrine, Dexamethasone, Placebo
- Keywords
- inferior alveolar nerve block, irreversible pulpitis, local anesthesia, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% lidocaine with 1:80,000 epinephrineDrug
Also called lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)
Anesthetic solution
DexamethasoneDrug
Also called Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran)
Corticostroide
PlaceboDrug
Also called sterile distilled water (Samen Pharmaceutical Co, Iran)
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | lidocaine \& Dexamethasone Receives: Drug: 2% lidocaine with 1:80,000 epinephrine; Drug: Dexamethasone |
| Non-dexamethasone | Placebo comparator | lidocaine \& Placebo Receives: Drug: 2% lidocaine with 1:80,000 epinephrine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
success of IAN Block anesthesia for the Dexamethasone group
The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
Measured: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
success of IAN Block anesthesia for the Non-dexamethasone group
The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
Measured: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
Secondary outcomes (1)
initial pain
rating the pain on Heft-Parker visual analog scale. This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Aug 2016
- Primary completion1 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences
- Investigators
- Masoud Saatchi, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531970
- Sponsor's protocol ID
- 396731
- Acronym
- IANB
- Status last verified
- May 2018
- First submitted
- 2 May 2018
- Last updated
- 22 May 2018
- 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 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT03531970
- Acronym / sponsor ID
- IANB / 396731
- Conditions
- Local Anesthesia
- Keywords
- inferior alveolar nerve block, irreversible pulpitis, local anesthesia, dexamethasone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 22 May 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.
The purpose of this prospective, randomized, double-blind study was to compare the success rate of IAN block injection carried out with two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml dexamethasone versus two cartridges of 2% lidocaine with 1:80000 epinephrine each combined with 0.2 ml sterile distilled water for endodontic treatment of mandibular molars with symptomatic irreversible pulpitis.
Detailed description
Several investigations have been carried out to demonstrate the effect of dexamethasone added to local anesthetics in regional block injections. These investigations shown that the addition of dexamethasone to local anaesthetics may prolong the duration of anesthesia and also results in a faster onset. It is hypothesized that dexamethasone added to lidocaine may affect the success rate of inferior alveolar nerve block
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: 2% lidocaine with 1:80,000 epinephrine, Drug: Dexamethasonelidocaine \& Dexamethasone |
| Non-dexamethasone | Placebo comparator | Drug: 2% lidocaine with 1:80,000 epinephrine, Drug: Placebolidocaine \& Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Key exclusion criteria (7 listed)
- younger than 18 years old
- history of significant medical conditions
- allergies to local anesthetics or sulfites
- pregnancy
- taking any medications that might influence anesthetic assessment
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 1:80,000 epinephrineAlso: lidocaine (2% Persocaine-E; Daroupakhsh, Tehran, Iran)Anesthetic solution | Drug | Dexamethasone, Non-dexamethasone |
| DexamethasoneAlso: Dexamethasone (Caspian Tamin Pharmaceutical Co, Rasht, Iran)Corticostroide | Drug | Dexamethasone |
| PlaceboAlso: sterile distilled water (Samen Pharmaceutical Co, Iran)Placebo | Drug | Non-dexamethasone |
Primary outcome
success of IAN Block anesthesia for the Dexamethasone group
Time frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
success of IAN Block anesthesia for the Non-dexamethasone group
Time frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)
The success of the anesthesia was defined as the tooth without pain or with mild pain according to the Heft-Parker visual analog scale (HP-VAS ≤ 54). This scale is a 170-mm horizontal line, divided into 4 categories. No pain corresponded to 0 mm; mild pain was defined as >0 mm and 54 mm. Mild pain category included faint, weak and mild pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. A score >54 mm and <114 mm indicated moderate pain and included the descriptor of moderate pain. Severe pain was defined as ≥114 mm. Severe pain was defined as strong, intense and maximum possible.
1 secondary outcome
initial pain
Time frame: Baseline
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 22 May 2018.
- 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.
Masoud Saatchi principal investigator
Isfahan University of Medical Sciences
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 2% lidocaine with 1:80,000 epinephrine and Dexamethasone in people with Local Anesthesia, run by Isfahan 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 2 inclusion and 7 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 22 May 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. Some participants in this study may receive a placebo. 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?
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 of IAN Block anesthesia for the Dexamethasone group (time frame: 15 minutes after the local anesthetic injection (at time of access cavity preparation)). 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?
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 22 May 2018.