Emdogain Minimally Invasive Surgical Technique

Completed · Not applicable

Conditions studied: Periodontitis

In brief

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).

Key facts

Study ID

NCT02551770

Run by

Institut Straumann AG

People needed

51

Starts

2015-10-01

Expected to finish

2019-08-30

Last updated by the study team

2019-10-17

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Periodontal and Implant Associates, Inc. — Cullman, Alabama, United States
• Periodontics and Implant Dentistry — Aurora, Colorado, United States
• Clinique Paro Excellence — Montreal, Quebec, Canada
• Universitätsmedizin der Johannes Gutenberg Universität Mainz — Mainz, Germany

Full record on ClinicalTrials.gov

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