Efficacy of Two Injection Techniques on Success Rate of Inferior Alveolar Nerve Anesthesia

Sponsor

Azad University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02543619

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Failed Mechanical Induction	Other: Injection technique	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparative Efficacy of Gow-Gates and Inferior Alveolar Nerve Block Injection Techniques on Success Rate of Anesthesia in Patients With Symptomatic Irreversible Pulpitis

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gow-Gates injection An injection technique for infra alveolar nerve anesthesia	Other: Injection technique 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	Other: Injection technique One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

Arm

Intervention/Treatment

Active Comparator: Gow-Gates injection

An injection technique for infra alveolar nerve anesthesia

Other: Injection technique

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

Other: Injection technique

One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

Outcome Measures

Primary Outcome Measures

Pain Score [4 Hours]
Heft Parker 170 mm Analog Visual Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dental Branch, AZad UMS	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Azad University of Medical Sciences

Investigators

Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS, MDS, Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nahid Mohammadzadeh Akhlaghi, Associate Professor, Azad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02543619

Other Study ID Numbers:

AZad UMS

First Posted:

Sep 7, 2015

Last Update Posted:

Sep 7, 2015

Last Verified:

Sep 1, 2015

Study Results

No Results Posted as of Sep 7, 2015