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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw
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
Change in Clinical Attachment Levels (CAL)
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.
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Gingival Margin (GM)
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.
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Pocket Probing Depth (PPD)
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.
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Full Mouth Plaque Score (FMPS)
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.
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Bleeding on Probing (BoP)
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.
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Time frame: Baseline and 12 Month Follow-Up Visit
Change in Root Dentin Hypersensitivity
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).
Time frame: Baseline and 12 Month Follow-Up Visit
Change in Post-surgical Pain
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.
Time frame: 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery