- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543619
Efficacy of Two Injection Techniques on Success Rate of Inferior Alveolar Nerve Anesthesia
September 4, 2015 updated by: Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences
Comparative Efficacy of Gow-Gates and Inferior Alveolar Nerve Block Injection Techniques on Success Rate of Anesthesia in Patients With Symptomatic Irreversible Pulpitis
Forty healthy patients with including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection.
Endodontic access cavity preparation has been initiated after complete anesthesia.
If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study was to assess the efficacy of Gow-Gates and inferior alveolar nerve block on success rate of anesthesia in patients with irreversible pulpitis.
In this prospective, randomized, double-blind study , forty healthy patients with symptomatic irreversible pulpitis and including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection.
Their pain has been evaluated by electric pulp tester every 5 minutes for two times.
Endodontic access cavity preparation has been initiated after complete anesthesia.
If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ).
The patients have been instructed to rate any pain during each of the mentioned steps.
The data have been analyzed by Mann-U-Whitney and CHI- SQUARE tests.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Dental Branch, AZad UMS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54) in one mandibular molar who need root canal treatment
- without systemic diseases
- non smoking
- non analgesic/sedative or any medicine consumption
- non pregnant
- non breast feeding
- the patients who received one conventional inferior alveolar nerve block and their block was failed ( without lip numbness)
Exclusion Criteria:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gow-Gates injection
An injection technique for infra alveolar nerve anesthesia
|
One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia
|
Active Comparator: Infra alveolar nerve block injection
An injection technique for infra alveolar nerve anesthesia
|
One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score
Time Frame: 4 Hours
|
Heft Parker 170 mm Analog Visual Scale
|
4 Hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS, MDS, Associate Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
September 4, 2015
First Submitted That Met QC Criteria
September 4, 2015
First Posted (Estimate)
September 7, 2015
Study Record Updates
Last Update Posted (Estimate)
September 7, 2015
Last Update Submitted That Met QC Criteria
September 4, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- AZad UMS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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