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 range18 Years – 80 Years
SexALL
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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…
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