NCT01593930

Brief Summary

The purpose of this study is to determine the success rate of pulpal anesthesia in mandibular firs molar following infiltration of 4% articaine alone and as supplemental injection after inferior alveolar nerve block(IANB).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

May 4, 2012

Last Update Submit

January 28, 2013

Conditions

Pulpal Anesthesia

Keywords

Pulp AnesthesiaArticaineLidocaine

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Changes in tooth response to Electric Pulp Tester (EPT) will be checked each 3 minutes after injection. The anesthesia will be considered successful if the subject will not response to EPT at the 80 reading in 2 consecutive tests.

    Every 3 minutes after injection

Secondary Outcomes (2)

  • Onset of anesthesia

    Every 3 minutes after injection

  • Duration of anesthesia

    Every 3 minutes after onset of anesthesia

Study Arms (4)

1 Articaine(Infiltration)

EXPERIMENTAL

Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Other: 1 Articaine(Infiltration)

2 Articaine(Infiltration)

EXPERIMENTAL

Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine

Other: 2 Articaine(Infiltration)

Lidocaine(IANB)+1Articaine(Infiltration)

EXPERIMENTAL

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Other: Lidocaine(IANB)+1Articaine(Infiltration)

Lidocaine(IANB)

EXPERIMENTAL

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine

Other: Lidocaine(IANB)

Interventions

Lidocaine(IANB)OTHER

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine

Also known as: Persocaine E
Lidocaine(IANB)
1 Articaine(Infiltration)OTHER

Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Also known as: Septanest
1 Articaine(Infiltration)
2 Articaine(Infiltration)OTHER

Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine

Also known as: Septanest
2 Articaine(Infiltration)
Lidocaine(IANB)+1Articaine(Infiltration)OTHER

Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine

Also known as: Persocaine E + Septanest
Lidocaine(IANB)+1Articaine(Infiltration)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with at least 1 vital first mandibular molar without any restoration or decay

You may not qualify if:

  • Patients with systemic conditions which eliminate the use of epinephrine
  • Patients with history of allergy to amide anesthetics or contents of local anesthetic cartridge
  • Pregnant women
  • Use of analgesics, opioids or any other drugs which influence the anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zahedan university of medical sciences, Vice-chancellor for research

Zahedan, Iran

Location

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kaveh Oloomi, DDS, MS

    Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

IR(1)