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Status unknownNCT03786211Updated Dec 24, 2018

IANB Success Rate With and Without Panoramic Help

A Phase 2/3 interventional study of IANB by the guide of Panoramic and IANB without the guide of Panoramic in Anesthesia and Anesthesia; Functional, sponsored by Hormozgan University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-24.

Sponsored by Hormozgan University of Medical Sciences · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia
  • Anesthesia; Functional

Keywords

  • Mandible
  • Anesthesia
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • sensitive to the regular anesthetics containing epinephrine.
  • patients with acute or chronic pericoronitis.
  • pregnancy
  • trismus
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    IANB without panoramic

    They will get Ianb without using panoramic

    Procedure: IANB by the guide of Panoramic · Procedure: IANB without the guide of Panoramic

  • Experimental
    IANB with panoramic

    They will get IANB by the guide of panoramic

    Procedure: IANB by the guide of Panoramic · Procedure: IANB without the guide of Panoramic

Interventions

  • ProcedureIANB by the guide of Panoramic

    IANB will be injected by the guide of panoramic radiograph

  • ProcedureIANB without the guide of Panoramic

    IANB will be injected without the guide of panoramic radiograph, in the routine way.

05

What researchers measure

Primary outcomes

  1. Number of participants with good Anesthesia

    Time frame: 30 minutes after injection

06

Study locations

1 of 1 sites recruiting
  • Dental clinic of BandarAbbas faculty of dentistry
    BandarAbbas, Hormozgan, Iran, Islamic Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03786211
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Sajad Ansari Fard (PhD, Student research committee, Hormozgan University of Medical Sciences) — Principal investigator
First posted
Dec 24, 2018
Start date
Nov 12, 2018
Primary completion
Jan 2019 (estimated)
Completion
Feb 2019 (estimated)
Last update
Dec 24, 2018

Study contacts

Sajad Ansarifard, DDS, PhD
Contact
Sajad.ansarifard@hums.ac.ir
?989366584476
Hossein Dabbagh
Contact
hossein.dabagh@hums.ac.ir
Hossein Dabbagh, Md, PhD
study chair · Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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