NCT03786211

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

2 months

First QC Date

December 8, 2018

Last Update Submit

December 21, 2018

Conditions

Keywords

MandibleAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Number of participants with good Anesthesia

    30 minutes after injection

Study Arms (2)

IANB without panoramic

ACTIVE COMPARATOR

They will get Ianb without using panoramic

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

IANB with panoramic

EXPERIMENTAL

They will get IANB by the guide of panoramic

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

Interventions

IANB will be injected by the guide of panoramic radiograph

IANB with panoramicIANB without panoramic

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

IANB with panoramicIANB without panoramic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental clinic of BandarAbbas faculty of dentistry

BandarAbbas, Hormozgan, Iran

RECRUITING

Study Officials

  • Hossein Dabbagh, Md, PhD

    Persian Gulf Oral and Dental Diseases Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

    STUDY CHAIR

Central Study Contacts

Sajad Ansarifard, DDS, PhD

CONTACT

Hossein Dabbagh

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Student research committee

Study Record Dates

First Submitted

December 8, 2018

First Posted

December 24, 2018

Study Start

November 12, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

December 24, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

Locations