Anesthesia; ReactionNCT01329874
Anesthetic Efficacy of Gow-Gates Versus Conventional Inferior Alveolar Nerve Block Techniques
A study testing Type of block injection in people with Anesthesia; Reaction and Pain, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether Gow Gates block injection is more effective than conventional alveolar nerve block in anesthetising mandibular molars with acute pulpitis. Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Reaction, Pain
- What is being tested?
- Type of block injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Sep 2011
- 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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mandibular molars with acute irreversible pulpitis
Who cannot join
- Unhealthy patients
- Patients who had taken pain killer less than 4 hours before appointment
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Dept of Endodontics, Faculty of Dentistry
Mashhad, Razavi Khorasan Province, 91735
Mohammad Hasan Zarrabi, D.D.S,M.S.c, +985118829525 ext. 291, zarrabimh@mums.ac.ir
Farzaneh Daneshvar, D.D.S, +985118829525 ext. 165, daneshvarf@mums.ac.ir
About this study
Official title: Comparison of the Anesthetic Efficacy in Mandibular Molars With Acute Irreversible Pulpitis With Either Conventional Inferior Alveolar or Gow-gates Nerve Block Techniques Plus Buccal or Lingual Infiltration
The purpose of this study is to determine whether Gow Gates block injection is more effective than conventional alveolar nerve block in anesthetising mandibular molars with acute pulpitis.
Read the detailed description
Pain management and adequate anesthesia are of critical importance for the endodontist. Traditionally, mandibular teeth are anesthetized via inferior alveolar nerve block (IAN). However, this technique provides a marginal success rate of 19-56% in patients with irreversible pulpitis.Gow Gates technique introduced in 1973 for anesthetizing of mandibular molars with more accuracy, success and safety.
- Conditions
- Anesthesia; Reaction, Pain
- Being tested
- Type of block injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of block injectionProcedure or surgery
Also called Gow Gates technique, Conventional inferior block injection
Patients will be selected from a group with acute irreversible pulpitis in mandibular molars. Half of the patients randomly selected for receiving gow gates block injection and half will receive traditional inferior block injection by 3.6 ml Lidocaine plus epinephrine.Teeth with no response to anesthetizing will be randomly divided into two group of either buccal or lingual infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Gow gates ,conventional block injection | No intervention | Patients will be selected from a group with acute irreversible pulpitis in mandibular molars. Half of the patients randomly selected for receiving gow gates block injection and half will receive traditional inferior block injection by 3.6 ml Lidocaine plus epinephrine.Teeth with no response to anesthetizing will be randomly divided into two group of either buccal or lingual infiltration. Receives: Procedure: Type of block injection |
| Buccal infiltration, Lingual infiltration | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant who will have pain following Gow gates or traditional inferior alveolar nerve block
All participant asked to show their pain degree on VAS for evaluation the efficacy of two different block injections and two different infiltrations ( Buccal and lingual) as supplementary injections.
Measured: 6 months
Secondary outcomes (1)
Heart rate monitoring
These records will be monitored by pulse oximeter device
Measured: before and after block injections (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Jamileh Ghoddusi, D.D.S,M.S.c, Principal investigator, Dental Research Center, Faculty of Dentistry, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329874
- Sponsor's protocol ID
- 89549
- Status last verified
- Jan 2011
- First submitted
- 4 Apr 2011
- Last updated
- 6 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Anesthetic Efficacy in Mandibular Molars With Acute Irreversible Pulpitis With Either Conventional Inferior Alveolar or Gow-gates Nerve Block Techniques Plus Buccal or Lingual Infiltration
- ClinicalTrials.gov ID
- NCT01329874
- Acronym / sponsor ID
- 89549
- Conditions
- Anesthesia; Reaction, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 6 Apr 2011 (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 whether Gow Gates block injection is more effective than conventional alveolar nerve block in anesthetising mandibular molars with acute pulpitis.
Detailed description
Pain management and adequate anesthesia are of critical importance for the endodontist. Traditionally, mandibular teeth are anesthetized via inferior alveolar nerve block (IAN). However, this technique provides a marginal success rate of 19-56% in patients with irreversible pulpitis.Gow Gates technique introduced in 1973 for anesthetizing of mandibular molars with more accuracy, success and safety.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gow gates ,conventional block injection | No intervention | Procedure: Type of block injectionPatients will be selected from a group with acute irreversible pulpitis in mandibular molars. Half of the patients randomly selected for receiving gow gates block injection and half will receive traditional inferior block injection by 3.6 ml Lidocaine plus epinephrine.Teeth with no response to anesthetizing will be randomly divided into two group of either buccal or lingual infiltration. |
| Buccal infiltration, Lingual infiltration | No intervention | – |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mandibular molars with acute irreversible pulpitis
Key exclusion criteria (2 listed)
- Unhealthy patients
- Patients who had taken pain killer less than 4 hours before appointment
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 |
|---|---|---|
| Type of block injectionAlso: Gow Gates technique, Conventional inferior block injectionPatients will be selected from a group with acute irreversible pulpitis in mandibular molars. Half of the patients randomly selected for receiving gow gates block injection and half will receive traditional inferior block injection by 3.6 ml Lidocaine plus epinephrine.Teeth with no response to anesthetizing will be randomly divided into two group of either buccal or lingual infiltration. | Procedure or surgery | Gow gates ,conventional block injection |
Primary outcome
Number of participant who will have pain following Gow gates or traditional inferior alveolar nerve block
Time frame: 6 months
All participant asked to show their pain degree on VAS for evaluation the efficacy of two different block injections and two different infiltrations ( Buccal and lingual) as supplementary injections.
1 secondary outcome
Heart rate monitoring
Time frame: before and after block injections (day 1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
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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.
Jamileh Ghoddusi, D.D.S,M.S.c principal investigator
Dental Research Center, Faculty of Dentistry, Mashhad 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 study testing Type of block injection in people with Anesthesia; Reaction and Pain, run by Mashhad 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 2 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 6 Apr 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Hasan Zarrabi, D.D.S,M.S.c (+985118829525 ext. 291, zarrabimh@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant who will have pain following Gow gates or traditional inferior alveolar nerve block (time frame: 6 months). 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 6 Apr 2011.