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

Local Anesthesia Clinical Trial

Official title:

Anesthetic Success of Inferior Alveolar Nerve Block for Mandibular Molars With Symptomatic Irreversible Pulpitis in Women Taking Selective Serotonin Reuptake Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884596
• Other study ID #: 394867
• Status: Completed
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2019
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 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

• active sites of pathosis in area of injection

• inability to give informed consent

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Drug:
• selective serotonin reuptake inhibitor
Taking any type of SSRI medicaments

Locations

Country	Name	City	State
Iran, Islamic Republic of	School of Dentistry, 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 the IAN block		taking any type of SSRI for at least six weeks prior to the study