Success of Inferior Alveolar Nerve Block in Women Taking Selective Serotonin Reuptake Inhibitors

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02884596
Collaborator
(none)
90
1
9
10

Study Details

Study Description

Brief Summary

To evaluate the success of inferior alveolar nerve block (IANB) for mandibular molars with irreversible pulpitis in women under treatment with selective serotonin reuptake inhibitors (SSRIs).

Condition or Disease Intervention/Treatment Phase
  • Drug: selective serotonin reuptake inhibitor

Detailed Description

Seventy patients with a diagnosis of symptomatic irreversible pulpitis in one mandibular molar were assigned to either SSRI users or SSRI non-users groups. SSRIs users were 45 women who take SSRIs referred for endodontic treatment from a psychiatric clinic to the clinic of the endodontic department of Isfahan University of Medical Sciences. SSRIs non-users were 45 women who did not take SSRIs referred for endodontic treatment to the same dental clinic. The protocol of the study was approved by the Ethics Committee of the university (no. 394867). Written informed consent was obtained from all the patients. The level of anxiety of the patients was determined by using the Corah Dental Anxiety Scale. The patients registered their baseline pain severity using a Heft-Parker visual analogue scale (HP-VAS). Two standard IANBs (1.8-mL cartridges) of 2% lidocaine with 1:100,000 epinephrine (Darupakhsh, Tehran, Iran) were administered to each patient. Fifteen minutes after injection, the teeth were isolated. Access cavity preparation was started. The patients was instructed by the same operator to mark his or her pain experienced during the access cavity preparation.

Study Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Anesthetic Success of Inferior Alveolar Nerve Block for Mandibular Molars With Symptomatic Irreversible Pulpitis in Women Taking Selective Serotonin Reuptake Inhibitors
Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Outcome Measures

Primary Outcome Measures

  1. the success rate of the IAN block [taking any type of SSRI for at least six weeks prior to the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

  • active sites of pathosis in area of injection

  • inability to give informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Dentistry, Isfahan University of Medical Sciences Isfahan Iran, Islamic Republic of 81747673461

Sponsors and Collaborators

  • Isfahan University of Medical Sciences

Investigators

  • Study Chair: Abbasali khademi, Isfahan University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Masoud Saatchi, DDS MSc, Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02884596
Other Study ID Numbers:
  • 394867
First Posted:
Aug 31, 2016
Last Update Posted:
Feb 15, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Masoud Saatchi, DDS MSc, Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Isfahan University of Medical Sciences
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2019