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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03117491
Other study ID # 395437
Secondary ID
Status Completed
Phase Phase 3
First received April 3, 2017
Last updated May 4, 2017
Start date December 1, 2015
Est. completion date December 1, 2016

Study information

Verified date April 2017
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.


Description:

Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 1, 2016
Est. primary completion date November 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- vital mandibular molar tooth

- diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

- younger than 18 years old

- history of significant medical conditions

- allergies to local anesthetics or sulfites

- pregnancy

- taking any medications that might influence anesthetic assessment

- active sites of pathosis in area of injection

- inability to give informed consent

Study Design


Related Conditions & MeSH terms

  • Pulpitis
  • Symptomatic Irreversible Pulpitis

Intervention

Procedure:
GGNB injections
The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
IANB injections
The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
GGNB + IANB injections
The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine

Locations

Country Name City State
Iran, Islamic Republic of Isfahan University of Medical Sciences Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale at time of access cavity preparation
Primary the success rate of IANB local anesthesia technique based on Heft-Parker visual analog scale at time of access cavity preparation
Primary the success rate of GGNB + IANB local anesthesia techniques based on Heft-Parker visual analog scale at time of access cavity preparation
Secondary initial pain based on Heft-Parker visual analog scale before treatment
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