NCT02543619

Brief Summary

Forty healthy patients with including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection. Endodontic access cavity preparation has been initiated after complete anesthesia. If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

September 4, 2015

Last Update Submit

September 4, 2015

Conditions

Failed Mechanical Induction

Outcome Measures

Primary Outcomes (1)

  • Pain Score

    Heft Parker 170 mm Analog Visual Scale

    4 Hours

Study Arms (2)

Gow-Gates injection

ACTIVE COMPARATOR

An injection technique for infra alveolar nerve anesthesia

Other: Injection technique

Infra alveolar nerve block injection

ACTIVE COMPARATOR

An injection technique for infra alveolar nerve anesthesia

Other: Injection technique

Interventions

Injection techniqueOTHER

One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

Gow-Gates injectionInfra alveolar nerve block injection

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54) in one mandibular molar who need root canal treatment
  • without systemic diseases
  • non smoking
  • non analgesic/sedative or any medicine consumption
  • non pregnant
  • non breast feeding
  • the patients who received one conventional inferior alveolar nerve block and their block was failed ( without lip numbness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Branch, AZad UMS

Tehran, Tehran Province, Iran

Location

Study Officials

  • Nahid Mohammadzadeh Akhlaghi, DDS, MDS

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 7, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

IR(1)