NCT01870232

Brief Summary

Dental anesthesia is routinely performed based on anatomical landmarks which can be variable leading to repeated injections and failure. Ultrasonography can be used to guide these injections by identifying the nerves, accompanying blood vessels and the bony landmarks. 20 healthy adult patients will be selected to receive ultrasound guided greater palatine nerve block (gpn) (10 patients) or inferior alveolar nerve (ian) block (10 patients) depending on the dental procedure they are undergoing. The study will evaluate the feasibility and success rates of the ultrasound guided gpn and ian nerve block.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

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

June 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

5.5 years

First QC Date

June 3, 2013

Last Update Submit

March 7, 2017

Conditions

Greater Palatine Nerve BlockInferior Alveolar Nerve Block

Keywords

Greater palatine nerve BlockInferior Alveolar nerve blockdental anesthesiaUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Success rate of nerve blocks

    the success rate of the blocks will be tested at 2, 5 and 10 minutes following the ultrasound guided injections. no anesthesia at the end of 10 minutes will be termed block failure

    10 minutes

Study Arms (1)

US guided block

EXPERIMENTAL

Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance

Procedure: US guided block

Interventions

US guided blockPROCEDURE

Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance

US guided block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MALE AND FEMALES PATIENTS
  • MANDIBULAR OR MAXILLARY DENTAL PROCEDURES IN THE DISTRIBUTION OF GREATER PALATINE OR INFERIOR ALVEOLAR NERVES.
  • ASA CLASS I, II

You may not qualify if:

  • ASA III AND IV
  • KNOWN NERVE INJURY OR NEUROPATHIES IN THE INTENDED BLOCK DISTRIBUTION
  • PATIENTS WITH KNOWN COAGULOPATHY
  • PATIENTS WITH KNOWN ALLERGY TO LOCAL ANESTHETIC OR THE PRESERVATIVE
  • PSYCHIATRIC ILLNESSES
  • LACK OF INFORMED CONSENT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre University Hospital

London, Ontario, N6A 5A5, Canada

Location

Study Officials

  • Sugantha Ganapathy, FRCPC

    Professor, Director, regional and Pain reseaerch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

CA(1)