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

NCT02313883 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2019-09-17

No results posted yet for this study

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

Interventions

DRUG

PerioSept(r)

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

Sponsors & Collaborators

  • Geistlich Pharma AG

    lead INDUSTRY

Principal Investigators

  • Michael McGuire, DDS · PerioHealth Clinic Houston

  • Donald Clem, DDS · Regenerative Solutions

  • Tae-Ju Oh, DDS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-07-02
Completion
2018-07-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313883 on ClinicalTrials.gov