Local AnesthesiaPhase 3NCT02726737
Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block
A Phase 3 study testing sodium bicarbonate, Lidocaine and sterile distilled water in people with Local Anesthesia, run by Masoud Saatchi at 1 site in Iran.
Trial summary
The purpose of this prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic 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?
- sodium bicarbonate, Lidocaine and sterile distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Dec 2014to Oct 2015
- Phase
- Phase 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 Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in the Mandibular First Molar With Symptomatic Irreversible Pulpitis: a Prospective, Randomized Double-blind Study
The purpose of this prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic
Read the detailed description
Several studies have been done by adding Sodium Bicarbonate to local anesthesia in dentistry based on the theory that the amount of local anesthetic in the free-base un-ionized form will decrease to provide greater lipid penetration of the nerve and this could be cause of the failure of local anesthesia injected into the inflamed tissue with low PH and conflicting results were obtained. But, there are no study that evaluate effect of increasing PH in periradicular tissue on hindrance of resistance channels with supplementary infiltration injection of Sodium Bicarbonate
- Conditions
- Local Anesthesia
- Being tested
- sodium bicarbonate, Lidocaine, sterile distilled water
- Keywords
- inferior alveolar nerve block, irreversible pulpitis, local anesthesia, sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
LidocaineDrug
sterile distilled waterDrug
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate | Experimental | 0.7 mL of 8.4% sodium bicarbonate \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine Receives: Drug: sodium bicarbonate; Drug: Lidocaine |
| Non-sodium bicarbonate | Active comparator | Sterile distilled water \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine Receives: Drug: Lidocaine; Drug: sterile distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis
Measured: Baseline
Secondary outcomes (1)
Heft-Parker visual analog scale recording of pain
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masoud Saatchi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Masoud Saatchi, Isfahan University of Medical Sciences
- Investigators
- Masoud Saatchi, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726737
- Sponsor's protocol ID
- 941456
- Status last verified
- Feb 2016
- First submitted
- 30 Mar 2016
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Bicarbonate Buccal Infiltration on the Success of Inferior Alveolar Nerve Block in the Mandibular First Molar With Symptomatic Irreversible Pulpitis: a Prospective, Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT02726737
- Acronym / sponsor ID
- 941456
- Conditions
- Local Anesthesia
- Keywords
- inferior alveolar nerve block, irreversible pulpitis, local anesthesia, sodium bicarbonate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Masoud SaatchiUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Apr 2016 (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 prospective, randomized, double blind study was to evaluate the effect of a buccal infiltration of sodium bicarbonate on the anesthetic success of the inferior alveolar nerve block (IANB) in patients with mandibular first molar experiencing symptomatic
Detailed description
Several studies have been done by adding Sodium Bicarbonate to local anesthesia in dentistry based on the theory that the amount of local anesthetic in the free-base un-ionized form will decrease to provide greater lipid penetration of the nerve and this could be cause of the failure of local anesthesia injected into the inflamed tissue with low PH and conflicting results were obtained. But, there are no study that evaluate effect of increasing PH in periradicular tissue on hindrance of resistance channels with supplementary infiltration injection of Sodium Bicarbonate
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate | Experimental | Drug: sodium bicarbonate, Drug: Lidocaine0.7 mL of 8.4% sodium bicarbonate \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine |
| Non-sodium bicarbonate | Active comparator | Drug: Lidocaine, Drug: sterile distilled waterSterile distilled water \& 0.3 mL of 2% lidocaine with 1:100,000 epinephrine |
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 |
|---|---|---|
| sodium bicarbonate | Drug | sodium bicarbonate |
| Lidocaine | Drug | Non-sodium bicarbonate, sodium bicarbonate |
| sterile distilled water | Drug | Non-sodium bicarbonate |
Primary outcome
success rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis
Time frame: Baseline
1 secondary outcome
Heft-Parker visual analog scale recording of 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 5 Apr 2016.
- 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 study chair
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 3 study testing sodium bicarbonate, Lidocaine and sterile distilled water in people with Local Anesthesia, run by Masoud Saatchi 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 5 Apr 2016. 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 phase mean?
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 rate of IANB in the mandibular first molar with symptomatic irreversible pulpitis (time frame: Baseline). 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 5 Apr 2016.