IANB Success Rate With and Without Panoramic Help

The Success of the Inferior Alveolar Nerve Block Anesthesia With Alveolar Nerve Localization by Using of Panoramic Radiography in Comparison to Routine IAN Block Anesthesia: RCT

Since it is difficult to achieve anesthesia in lower jaw and the success rate of IANB is low and there are a lot of anatomic variations for the location of inferior alveolar nerve in different races, investigators decided to compare the success rate of inferior alveolar nerve block, with and without using a panoramic radiograph in Bandar Abbas population, and see if using a panoramic radiograph can increase the preciseness of the injection.

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Anesthesia; Functional
• Intervention / Treatment: Procedure: IANB by the guide of Panoramic; Procedure: IANB without the guide of Panoramic

Detailed Description

This is a double blinded cross-over randomized controlled trial study conducted on all the patients of the dental clinic indicated for bilateral extraction or filling.

The randomization method is block balanced randomization. All patients will ask to fulfill the ethical Form. This form acquired demographic information (e.g. age, sex) about patients. A panoramic radiograph will take from those who matched the inclusion criteria and signed the agreement. Then a tooth from one side will be treated and the tooth from the other side of the mouth will treat at least 2 weeks later by the same dentist.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sajad Ansarifard, DDS, PhD; Phone Number: ?989366584476; Email: Sajad.ansarifard@hums.ac.ir
• Study Contact Backup: Name: Hossein Dabbagh; Email: hossein.dabagh@hums.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • BandarAbbas, Hormozgan, Iran, Islamic Republic of
      • Recruiting
      • Dental clinic of BandarAbbas faculty of dentistry
      • Contact: Hossein Dabbagh, Md, PhD; Email: hossein.dabagh@hums.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients indicated for bilateral tooth extractions of fillings.
• Physically and mentally healthy patients who could express their pain.
• having panoramic radiograph from the past six months for other dental purposes.

Exclusion Criteria:

• sensitive to the regular anesthetics containing epinephrine.
• patients with acute or chronic pericoronitis.
• pregnancy
• trismus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IANB without panoramic; They will get Ianb without using panoramic	Procedure: IANB by the guide of Panoramic; IANB will be injected by the guide of panoramic radiograph; Procedure: IANB without the guide of Panoramic; IANB will be injected without the guide of panoramic radiograph, in the routine way.
Experimental: IANB with panoramic; They will get IANB by the guide of panoramic	Procedure: IANB by the guide of Panoramic; IANB will be injected by the guide of panoramic radiograph; Procedure: IANB without the guide of Panoramic; IANB will be injected without the guide of panoramic radiograph, in the routine way.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with good Anesthesia	30 minutes after injection

Collaborators and Investigators

• Sponsor: Hormozgan University of Medical Sciences
• Investigators: Study Chair: Hossein Dabbagh, Md, PhD, Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: December 8, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Anesthesia; Mandible
• Other Study ID Numbers: HMS 50126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No