Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With… (NCT04093895) | Clinical Trial Compass
CompletedPhase 2
Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis
United States12 participantsStarted 2019-08-26
Plain-language summary
A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis.
Who can participate
Age range
18 Years – 80 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:
* Subjects male or female 18 to 80 years of age, inclusive.
* Subjects must be diagnosed with moderate to severe generalized periodontitis (ADA Classification Case Type III or IV) as determined by the investigator.
* Subjects must have at least 4 qualifying target teeth (having a dental pocket with PPD ≥ 6mm and BOP) (teeth having no endodontic disease - treated or untreated).
* Subjects must have at least 12 teeth in the functional dentition, excluding second and third molars In subjects with limited dentition, tooth loss should not be due to traumatic occlusion
* Females of childbearing potential must agree to use of birth control (hormonal, barrier method or abstinence). Hormonal contraceptives must have started not fewer than 30-days before baseline visit/Day 1.
* Subjects must sign informed consent document(s) prior to initiation of any study-specific procedures and treatments.
* Subjects who are 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 investigational drug product.
* Presence of an acute periodontal abscess.
* Subjects with healing disorders (e.g. uncontrolled diabetes mellitus, oral cancer) that could compromise wound healing and/or preclude periodontal surgery.
* Subjects who are taking medications that compromise wound healing presenting with clinical evidence o…
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.
What they're measuring
1
Efficacy: Mean probing pocket depth (PPD) reduction (mm) of all study pockets (pockets with PPD > 6 mm and bleeding on probing (BOP) at baseline on target teeth) at subject level and across all subjects