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IANB Success Rate With and Without Panoramic Help

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ClinicalTrials.gov Identifier: NCT03786211
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sajad Ansari Fard, Hormozgan University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Anesthesia; Functional Procedure: IANB by the guide of Panoramic Procedure: IANB without the guide of Panoramic Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

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.




Primary Outcome Measures :
  1. Number of participants with good Anesthesia [ Time Frame: 30 minutes after injection ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786211


Contacts
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Contact: Sajad Ansarifard, DDS, PhD ?989366584476 Sajad.ansarifard@hums.ac.ir
Contact: Hossein Dabbagh hossein.dabagh@hums.ac.ir

Locations
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Iran, Islamic Republic of
Dental clinic of BandarAbbas faculty of dentistry Recruiting
BandarAbbas, Hormozgan, Iran, Islamic Republic of
Contact: Hossein Dabbagh, Md, PhD       hossein.dabagh@hums.ac.ir   
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
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Study Chair: Hossein Dabbagh, Md, PhD Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

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Responsible Party: Sajad Ansari Fard, PhD, Student research committee, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03786211     History of Changes
Other Study ID Numbers: HMS 50126
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sajad Ansari Fard, Hormozgan University of Medical Sciences:
Mandible
Anesthesia