A Phase I/II Study to Evaluate the Safety and Efficacy of PerioSept® as Adjunct to SRP in Subject… (NCT02313883) | Clinical Trial Compass
CompletedPhase 1/2
A Phase I/II Study to Evaluate the Safety and Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis
United States127 participantsStarted 2015-07
Plain-language summary
A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and Root Planing in Subjects with Periodontitis
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 74 years of age, inclusive
* Diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV)
* Must have at least 4 qualifying Study Pockets (PPD ≥ 5mm and BOP) in at least 2 quadrants (main trial)
* Subjects must sign informed consent document(s) prior to initiation of any study-specific procedures and treatments
* Agree to utilize study-provided tooth paste and tooth brush and agree to follow their standard oral hygiene routine with limitations noted below from the Day 1 visit through the end of the study
* Sexually active subjects (both men and women) who agree to use acceptable contraceptive methods for the duration of the study
* Able and willing to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
* History of and/or known risk of life-threatening anaphylactic reactions to taurolidine, any of the components in the PS drug product, and other drugs or agonists (e.g., penicillin, nuts, insect stings)
* Presence of an acute periodontal abscess
* Known endodontic disease
* Diabetes uncontrolled by medication defined as fasting blood glucose documented at ≥200 mg/dL within 90 days of Day 1
* History of illegal drug or alcohol abuse within the past 12 months and/or testing positive for illegal drugs (including marijuana) at the Screening Visit
* Pregnant or nursing female subjects; women of child-bearing potential must have a negative serum or urine pregnancy test within 30…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.