Local AnesthesiaNCT02884596
Success of Inferior Alveolar Nerve Block in Women Taking Selective Serotonin Reuptake Inhibitors
An observational study of Local Anesthesia, run by Isfahan University of Medical Sciences at 1 site in Iran.
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). Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- selective serotonin reuptake inhibitor
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Jun 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, 81747673461
About this study
Official title: Anesthetic Success of Inferior Alveolar Nerve Block for Mandibular Molars With Symptomatic Irreversible Pulpitis in Women Taking Selective Serotonin Reuptake Inhibitors
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).
Read the 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.
- Conditions
- Local Anesthesia
- Being tested
- selective serotonin reuptake inhibitor
- Keywords
- Inferior alveolar nerve block, irreversible pulpitis, selective serotonin reuptake inhibitor antidepressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective serotonin reuptake inhibitorDrug
Also called SSRI
Taking any type of SSRI medicaments
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of the IAN block
Measured: taking any type of SSRI for at least six weeks prior to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences
- Investigators
- Abbasali khademi, Study chair, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884596
- Sponsor's protocol ID
- 394867
- Status last verified
- Feb 2019
- First submitted
- 21 Aug 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Success of Inferior Alveolar Nerve Block for Mandibular Molars With Symptomatic Irreversible Pulpitis in Women Taking Selective Serotonin Reuptake Inhibitors
- ClinicalTrials.gov ID
- NCT02884596
- Acronym / sponsor ID
- 394867
- Conditions
- Local Anesthesia
- Keywords
- Inferior alveolar nerve block, irreversible pulpitis, selective serotonin reuptake inhibitor antidepressants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- vital mandibular molar tooth
- diagnosis of symptomatic irreversible pulpitis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| selective serotonin reuptake inhibitorAlso: SSRITaking any type of SSRI medicaments | Drug | – |
Primary outcome
the success rate of the IAN block
Time frame: taking any type of SSRI for at least six weeks prior to the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abbasali khademi study chair
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Local Anesthesia, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of the IAN block (time frame: taking any type of SSRI for at least six weeks prior to the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.