NCT02884596

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Shorter than P25 for all trials

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

June 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

August 21, 2016

Last Update Submit

February 11, 2019

Conditions

Keywords

Inferior alveolar nerve blockirreversible pulpitisselective serotonin reuptake inhibitor antidepressants

Outcome Measures

Primary Outcomes (1)

  • the success rate of the IAN block

    taking any type of SSRI for at least six weeks prior to the study

Interventions

Taking any type of SSRI medicaments

Also known as: SSRI

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Seventy adult women patients participated in this study and were assigned to either SSRIs users or SSRIs 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.

You may qualify if:

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Isfahan University of Medical Sciences

Isfahan, 81747673461, Iran

Location

MeSH Terms

Interventions

Selective Serotonin Reuptake Inhibitors

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Study Officials

  • Abbasali khademi

    Isfahan University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences

Study Record Dates

First Submitted

August 21, 2016

First Posted

August 31, 2016

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations