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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01329874
Other study ID # 89549
Secondary ID
Status Recruiting
Phase N/A
First received April 4, 2011
Last updated April 5, 2011
Start date March 2011
Est. completion date September 2011

Study information

Verified date January 2011
Source Mashhad University of Medical Sciences
Contact Mohammad Hasan Zarrabi, D.D.S,M.S.c
Phone +985118829525
Email zarrabimh@mums.ac.ir
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 50 Years
Eligibility Inclusion Criteria:

- Mandibular molars with acute irreversible pulpitis

Exclusion Criteria:

- Unhealthy patients

- Patients who had taken pain killer less than 4 hours before appointment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Procedure:
Type of 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.

Locations

Country Name City State
Iran, Islamic Republic of Dept of Endodontics, Faculty of Dentistry Mashhad Khorasan Razavi

Sponsors (1)

Lead Sponsor Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months No
Secondary Heart rate monitoring These records will be monitored by pulse oximeter device before and after block injections (day 1) No
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