Clinical Trial Details

NCT ID: NCT02551770
Date Last Changed: December 21, 2016

Overview

Research Study Summary

A clinical research study of Scaling and root planing with Emdogain and Scaling and root planing without Emdogain for the treatment of Periodontitis

Research Study Title

Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study

Purpose

The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).

To Learn more

Recruitment Details

Gender
All
Age
21 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Institut Straumann AG
Duration
19 Months
Facility Type
N/A
Compensation

Eligibility

All ages 21 Years to 85 Years

Inclusion Criteria:

  • Subjects must have voluntarily signed the informed consent form before any study related procedures

  • Subjects must be males or females who are 18-85 years of age

  • Subjects must have moderate to severe chronic, generalized periodontitis with pockets of 5 mm - 8mm probing depth in at least 2 pockets per contralateral quadrants in one arch (study teeth)

  • Subjects must be committed to the study and the required follow-up visits

  • Subjects must be in good general health as assessed by the Investigator

Exclusion Criteria:

  • Subjects taking or intending to take any medications during the duration of the study that will potentially affect healing and inflammation

  • Subjects who are currently heavy smokers (defined > 10 cigarettes per day or > 1 cigar per day) or who use chewing tobacco

  • Subjects being treated with systemic antibiotics or subjects that were treated with systemic antibiotics within 3 months prior to treatment in this study

  • Subjects with uncontrolled diabetes

  • Subjects that are immunocompromised or immunosuppressed

  • Subjects that cannot provide informed consent

  • Subjects with drug or alcohol abuse

  • Subjects that have undergone periodontal root planing or periodontal surgery in the last 6 months

  • Subjects that are pregnant

  • Subjects with necrotizing periodontitis or periodontitis related to systemic disease

  • Teeth with pockets with probing depth ≥ 9 mm will not classify as study teeth

  • Teeth with pockets or defects with furcation involvement will not classify as study teeth

  • Teeth with mobility degree > 1 without splint will not classify as study teeth

  • Subjects with test and control sites in the two quadrants on adjacent teeth

  • Patients with compromised health conditions such as diabetes, systemic diseases, high dose steroid therapy, bone metabolic diseases, radiation or immune-oppressive therapy, and infections or vascular impairment at the surgical site

  • Subjects with conditions or circumstances, in the opinion of the Investigator , which would prevent completion of study participation or interfere with analysis of study results

Site Locations (4)

Country State City Zip Facility and Contact
United States Alabama Cullman 35055 Periodontal and Implant Associates, Inc.
Jennifer Hirsch Doobrow, DMD
256-734-8588
United States Colorado Aurora 80012-3202 Periodontics and Implant Dentistry
Pamela K. McClain, DDS
303-696-7885
Canada Quebec Montreal H3B 3A7 Clinique Paro Excellence
Veronique Benhamou, DDS
514-303-7276
Germany Mainz 55131 Universitätsmedizin der Johannes Gutenberg Universität Mainz
Adrian Kasaj, Prof.Dr.h.c.
06131 177157
adrian.kasaj@unimedizin-mainz.de

Contact

Kelly E Jork, MS
978-747-2533
E-mail:

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