Clinical trial NCT02551770: Emdogain Minimally Invasive Surgical Technique
Official title: Straumann® Emdogain® Application In Conjunction With Minimally Invasive Surgical Technique For Periodontal Disease Treatment: A Split-Mouth Design Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinical Attachment Levels (CAL)
timeFrame: Baseline and 12 Month Follow-Up Visit
Secondary outcomes:
measure: Change in Gingival Margin (GM)
timeFrame: Baseline and 12 Month Follow-Up Visit
measure: Change in Pocket Probing Depth (PPD)
timeFrame: Baseline and 12 Month Follow-Up Visit
measure: Change in Full Mouth Plaque Score (FMPS)
timeFrame: Baseline and 12 Month Follow-Up Visit
measure: Change in Bleeding on Probing (BoP)
timeFrame: Baseline and 12 Month Follow-Up Visit
measure: Change in Root Dentin Hypersensitivity
timeFrame: Baseline and 12 Month Follow-Up Visit
measure: Change in Post-surgical Pain
timeFrame: 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Periodontal and Implant Associates, Inc.
state: Alabama
city: Aurora
country: United States
facility: Periodontics and Implant Dentistry
state: Colorado
city: Montreal
country: Canada
facility: Clinique Paro Excellence
state: Quebec
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz
Study officials:
affiliation: Periodontics and Implant Dentistry
name: Pamela K McClain, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Paro Excellence
name: Veronique Benhamou, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Periodontal & Implant Associates
name: Jennifer H Doobrow, DMD
role: PRINCIPAL_INVESTIGATOR
References: