Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

NCT04093895 | Completed Phase 2 FDA Drug

• 1 other identifier: PSPD 2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis

Keywords

Periodontitis; taurolidine; PerioSept

Outcome Measures

Primary Outcomes (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

  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

  Baseline, Week 12

Secondary Outcomes (16)

• Efficacy: Mean PPD reduction (mm) of all study pockets per patient

  Baseline, Week 4

• Efficacy: Number of study pockets changing from ≥ 6 mm PPD to ≤5 mm PPD

  Baseline; Week 4, 12

• Efficacy: Change in Clinical attachment level (CAL) of all study pockets

  Baseline; Week 4, 12

• Efficacy: Change in plaque index (PI) of all study pockets

  Baseline; Week 4, 12

• Efficacy: Change in gingival index (GI) of all study pockets

  Baseline; Week 4, 12

Other Outcomes (2)

• Exploratory: Clinician reported outcome for delivery device handling and ease of use

  Day 1, 2

• Exploratory: Microbiological counts of periodontal pathogens in biofilm samples of 4 study pockets

  Baseline (before treatment); Week 4, 12

Study Arms (1)

SRP and 3% PerioSept(r)

EXPERIMENTAL

Scaling and root planing followed by 3% PerioSept® drug administration

Drug: PerioSept(r)

Interventions

PerioSept(r) DRUG

Scaling and root planing followed by 3% PerioSept(r) administration

Also known as: Taurolidine

SRP and 3% PerioSept(r)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 of secondary hyperplastic gingival tissue reactions (e.g. calcium channel blockers or anti-seizure medications)
• Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test.
• Use of systemic antibiotics and, topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) within 45 days prior to Day 1 or expected use during the study trial period.
• An existing condition that may warrant use of antibiotics during the study trial period.
• Known Human Immunodeficiency Virus infection or other immunodeficiency syndrome.
• Subjects with active infectious diseases (e.g. hepatitis, HIV or tuberculosis)
• Use of agents known to affect periodontal status during the trial and/or use within 45 days prior to Day 1 e.g. immunosuppressants, nasal or oral corticosteroids, calcium channel blockers, phenytoin or anticoagulants.
• Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day (smokeless nicotine products are NOT excluded)
• Participation in another clinical study with an investigational agent within 90 days prior to Day 1.
• Subjects who received oral health treatments/interventions within 90 days of Day 1, which the investigator believes may interfere with the periodontal parameters to be assessed in this study (e.g., significant dental and/or gum/oral tissue work).
• SRP or periodontal surgery within 12 months prior to Day 1.
• Subject who have a medical and/or dental condition (e.g. a current clinically unstable occlusal situation) and/or use medications/supplements which the investigator believes makes him/her unsuitable for participation in the study

Sponsors & Collaborators

• Geistlich Pharma AG: lead

Study Sites (1)

Perio Health Professionals

Houston, Texas, 77063, United States

Location

MeSH Terms

Conditions

Periodontitis

Interventions

taurolidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Michael McGuire, DDS

  PerioHealth Clinic Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm, uncontrolled, open-label

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 18, 2019
• Study Start: August 26, 2019
• Primary Completion: June 10, 2020
• Study Completion: September 25, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (1)