Symptomatic Irreversible PulpitisPhase 3NCT03117491
Effect of Inferior Alveolar and Gow-Gates Nerve Block Techniques for Symptomatic Mandibular Molars
A Phase 3 study testing GGNB injections, IANB injections and GGNB + IANB injections in people with Symptomatic Irreversible Pulpitis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- GGNB injections, IANB injections and GGNB + IANB injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2015to 1 Dec 2016
- 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
Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.
Read the detailed description
Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- GGNB injections, IANB injections, GGNB + IANB injections
- Keywords
- Gow-Gates nerve block, Inferior alveolar nerve block, local anesthesia, molar, pulpitis
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GGNB injectionsProcedure or surgery
The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
IANB injectionsProcedure or surgery
The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
GGNB + IANB injectionsProcedure or surgery
The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
| Study group | Role | What they receive |
|---|---|---|
| GGNB injection technique | Active comparator | In GGNB group, every patient received two1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique Receives: Procedure: GGNB injections |
| IANB injection technique | Active comparator | In IANB group, every patient received two 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique Receives: Procedure: IANB injections |
| GGNB + IANB injection technique | Active comparator | In IANB + GGNB group, every patient received one 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique and one 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique Receives: Procedure: GGNB + IANB injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale
Measured: at time of access cavity preparation
the success rate of IANB local anesthesia technique based on Heft-Parker visual analog scale
Measured: at time of access cavity preparation
the success rate of GGNB + IANB local anesthesia techniques based on Heft-Parker visual analog scale
Measured: at time of access cavity preparation
Secondary outcomes (1)
initial pain based on Heft-Parker visual analog scale
Measured: before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Dec 2015
- Primary completion1 Nov 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117491
- Sponsor's protocol ID
- 395437
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inferior Alveolar and Gow-Gates Nerve Block Techniques for Symptomatic Mandibular Molars
- ClinicalTrials.gov ID
- NCT03117491
- Acronym / sponsor ID
- 395437
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Gow-Gates nerve block, Inferior alveolar nerve block, local anesthesia, molar, pulpitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 18 Apr 2017 (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.
Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.
Detailed description
Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GGNB injection technique | Active comparator | Procedure: GGNB injectionsIn GGNB group, every patient received two1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique |
| IANB injection technique | Active comparator | Procedure: IANB injectionsIn IANB group, every patient received two 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique |
| GGNB + IANB injection technique | Active comparator | Procedure: GGNB + IANB injectionsIn IANB + GGNB group, every patient received one 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique and one 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique |
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 |
|---|---|---|
| GGNB injectionsThe patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine | Procedure or surgery | GGNB injection technique |
| IANB injectionsThe patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine | Procedure or surgery | IANB injection technique |
| GGNB + IANB injectionsThe patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine | Procedure or surgery | GGNB + IANB injection technique |
Primary outcome
the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale
Time frame: at time of access cavity preparation
the success rate of IANB local anesthesia technique based on Heft-Parker visual analog scale
Time frame: at time of access cavity preparation
the success rate of GGNB + IANB local anesthesia techniques based on Heft-Parker visual analog scale
Time frame: at time of access cavity preparation
1 secondary outcome
initial pain based on Heft-Parker visual analog scale
Time frame: before treatment
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 9 May 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 GGNB injections, IANB injections and GGNB + IANB injections in people with Symptomatic Irreversible Pulpitis, 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 9 May 2017. 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?
the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale (time frame: at time of access cavity preparation). The study lists 3 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 9 May 2017.