A Phase I/II Study to Evaluate the Safety and Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis

NCT02313883 | Completed Phase 1

• 1 other identifier: PSPD 1-2
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Periodontitis

Keywords

periodontitis; taurolidine (PerioSept(r)); scaling and root planing

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability:Hematology safety labs, Chem 14, urine analysis, ECG, treatment emergent adverse events, local irritation, patient reported pain, sensisitivity, burning stinging

  Hematology safety labs, Chem 14, urine analysis, ECG, treatment emergent adverse events, local irritation, patient reported pain, sensisitivity, burning stinging

  6 months

• Efficacy: Reduction in probing pocket depth (PPD)

  Reduction in probing pocket depth (PPD)

  6 months

Secondary Outcomes (4)

• Efficacy REC and CAL: Changes from baseline in Recession (REC)/Clinical attachment level (CAL)

  6 months

• Efficacy BOP: Presence or absence of bleeding on probing (BOP)

  6 months

• Efficacy PI: Changes from baseline in Plaque index

  6 months

• Efficacy GI: Changes from baseline in Gingival index

  6 months

Other Outcomes (1)

• Efficacy microbial: Microbial Counts of Periodontal Pathogens

  6 months

Study Arms (5)

SRP only

PLACEBO COMPARATOR

Scaling and root planing only

Drug: PerioSept(r)

SRP and Placebo

PLACEBO COMPARATOR

Scaling and root planing followed by placebo drug administration

Drug: PerioSept(r)

SRP and 0.3% PerioSept(r)

EXPERIMENTAL

Scaling and root planing followed by 0.3% PerioSept(r) drug administration

Drug: PerioSept(r)

SRP and 1 % PerioSept(r)

EXPERIMENTAL

Scaling and root planing followed by 1% PerioSept(r) drug administration

Drug: PerioSept(r)

SRP and 3% PerioSept(r)

EXPERIMENTAL

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

Drug: PerioSept(r)

Interventions

PerioSept(r) DRUG

Taurolidine is derived from the amino acid taurine and has antimicrobial and immune modulating properties

Also known as: Taurolidine

SRP and 0.3% PerioSept(r); SRP and 1 % PerioSept(r); SRP and 3% PerioSept(r); SRP and Placebo; SRP only

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 days and within 24 h prior to all treatment/dosing days
• Use of systemic antibiotics and topically applied oral antibiotics and other antimicrobial agents (e.g., chlorhexidine) during the trial and within 30 days of Day 1.
• An existing condition that may warrant use of antibiotics during the trial (e.g., white blood cell count indicative of ongoing infection noted at Screening Visit, subject with cystic fibrosis or chronic obstructive pulmonary disorder with history of frequent, recurrent lung infections)
• History of and/or testing positive for Hepatitis B or C, Human Immunodeficiency Virus or other immunedeficiency syndrome or positive test for such at Screening Visit
• Use of chewing gum of any kind and dental flossing for one week after all study treatments and use of any other oral dentifrices or oral health agents/treatments other than those provided herein for the study duration
• Use within 30 days prior to Day 1, during trial or a condition for which use is anticipated during trial: topical oral, nasal and systemic corticosteroids, chronic (2 continuous weeks) non-steroidal anti-inflammatory drugs (NSAIDs)
• Use of the agents known to affect periodontal status during the trial and/or use within 30 days prior to Day 1: immunesuppressants, calcium antagonist, phenytoin or anticoagulants
• Heavy smokers/tobacco users are excluded: defined as those smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day
• For non-heavy smokers, smoking ≥ 10 cigarettes or ≥ 4 cigars or ≥ 4 pipes per day is prohibited for the duration of the trial
• Use of electronic/smokeless and herbal cigarettes/pipes and oral smokeless/chewing tobacco within 30 days of Day 1 excluded and all use of these products is prohibited during trial

Sponsors & Collaborators

• Geistlich Pharma AG: lead

Study Sites (4)

Regenerative solutions

Fullerton, California, 92835, United States

Location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

• Donald Clem, DDS

  Regenerative Solutions

  PRINCIPAL INVESTIGATOR

• Tae-Ju Oh, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: July 1, 2015
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2018
• Last Updated: September 17, 2019

Record last verified: 2019-09

Locations

US (4)