Clinical trial NCT02884596: Success of Inferior Alveolar Nerve Block in Women Taking Selective Serotonin Reuptake Inhibitors
Official title: Anesthetic Success of Inferior Alveolar Nerve Block for Mandibular Molars With Symptomatic Irreversible Pulpitis in Women Taking Selective Serotonin Reuptake Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Local Anesthesia
Keywords: Inferior alveolar nerve block
irreversible pulpitis
selective serotonin reuptake inhibitor antidepressants
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: the success rate of the IAN block
timeFrame: taking any type of SSRI for at least six weeks prior to the study
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: School of Dentistry, Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Abbasali khademi
role: STUDY_CHAIR
References: