Emdogain Minimally Invasive Surgical Technique

Not Applicable

Completed

Conditions: Periodontitis

Interventions: Procedure: Scaling and root planing without Emdogain
Procedure: Scaling and root planing
Device: Emdogain application

Registration Number: NCT02551770

Lead Sponsor: Institut Straumann AG

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (without Emdogain)	Scaling and root planing without Emdogain	Scaling and root planing without Emdogain
Test (with Emdogain)	Scaling and root planing	Scaling and root planing with Emdogain
Test (with Emdogain)	Emdogain application	Scaling and root planing with Emdogain

Primary Outcome Measures

Name	Time	Method
Change in Clinical Attachment Levels (CAL)	Baseline and 12 Month Follow-Up Visit	CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.

Secondary Outcome Measures

Name	Time	Method
Change in Post-surgical Pain	1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery	Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.
Change in Gingival Margin (GM)	Baseline and 12 Month Follow-Up Visit	GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.
Change in Pocket Probing Depth (PPD)	Baseline and 12 Month Follow-Up Visit	PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.
Change in Full Mouth Plaque Score (FMPS)	Baseline and 12 Month Follow-Up Visit	FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.
Change in Bleeding on Probing (BoP)	Baseline and 12 Month Follow-Up Visit	For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.
Change in Root Dentin Hypersensitivity	Baseline and 12 Month Follow-Up Visit	Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild).

Trial Locations

Locations (4): Periodontics and Implant Dentistry
🇺🇸
Aurora, Colorado, United States
Periodontal and Implant Associates, Inc.
🇺🇸
Cullman, Alabama, United States
Universitätsmedizin der Johannes Gutenberg Universität Mainz
🇩🇪
Mainz, Germany
Clinique Paro Excellence
🇨🇦
Montreal, Quebec, Canada