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Corticosteroid

Steroid for Pain Management (SAILS-Steroid Trial)

Phase 4

Recruiting

Led By Cecile Feldman, DMD, BMA

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24, 48 and 72 hours

Awards & highlights

SAILS-Steroid Trial Summary

This trial will test if using corticosteroids before surgery can reduce the need for opioids for pain relief after removing impacted wisdom teeth. The study will involve dentists and aims to provide them with better

Who is the study for?

This trial is for adults over 18 in good health who are planning to have their wisdom teeth removed. Participants must understand and sign a consent form, follow study procedures, have a smartphone, and be available for the whole study. They should agree to use contraception like condoms or pills.Check my eligibility

What is being tested?

The trial is testing if a steroid called Dexamethasone can reduce the need for opioid painkillers after wisdom tooth surgery. It's a pilot study where patients are randomly given either Dexamethasone or a placebo without knowing which one they receive.See study design

What are the potential side effects?

Dexamethasone may cause side effects such as increased appetite, mood changes, trouble sleeping, indigestion, or an increase in blood sugar levels.

SAILS-Steroid Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24, 48 and 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24, 48 and 72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24, 48 and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pain Experience

Satisfaction With Medication

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

SAILS-Steroid Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SteroidExperimental Treatment1 Intervention

Dexamethasone 8mg

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,180 Total Patients Enrolled

Cecile Feldman, DMD, BMAPrincipal InvestigatorRutgers University, School of Dental Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"The information available on clinicaltrials.gov confirms that this research study is currently seeking eligible participants. The trial was initially posted on November 27, 2023, and the most recent update was made on March 18, 2024."

Answered by AI

What is the current number of individuals participating in this clinical investigation?

"Indeed, the details on clinicaltrials.gov illustrate that patient recruitment is ongoing for this investigation. The trial was first listed on 11/27/2023 and last modified on 3/18/2024. A total of 52 participants are sought from one designated site."

Answered by AI

Is the research study open to participants who are older than 35 years of age?

"Eligible participants for this research study must be between 18 and 99 years old. Separate trials are available for individuals under 18 and those aged over 65, with a total of 27 clinical trials catering to these age groups."

Answered by AI

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"In this research endeavor, there is a call for 52 individuals aged between 18 and 99 who are seeking pain management. Noteworthy prerequisites encompass the ability to comprehend the informed consent documents fully, willingness to adhere meticulously to study protocols including possessing a smartphone, planning for extraction of one or more impacted mandibular third molars, being at least 18 years old, maintaining good general health as indicated by medical records, using contraceptive methods such as condoms or intrauterine devices."

Answered by AI

What are the potential risks associated with administering steroids to patients?

"Steroid safety has been rated 3 out of a possible 3 by our experts at Power due to the Phase 4 status, indicating that this treatment is authorized for use."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid

Cecile A. Feldman, DMD 2023. "Search to Advance Limited Use of Opioids Pilot: Optimization of Non-Opioid Therapy With a Steroid". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06074263.