Prospective, randomized, within subjects-controlled design
The objective of this trial is to evaluate clinical healing outcomes of microsurfaced cadaveric ADM (Markman Biologics) used in sites with \< 1 mm of attached gingiva requiring soft tissue grafting without root coverage as compared to control cadaveric ADM (AlloDerm, LifeCell) over 180-day post-op period. During the treatment period, each site will be monitored for soft tissue healing and augmentation of keratinized tissue width. All subjects will be seen at post-op day 7, 14, 30, 90, and 180.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
an ADM which has been scored (microsurfaced)
AlloDerm tissue matrix
Perio Health Professionals
Houston, Texas, United States
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color
tissue color
Time frame: Day 14 post op
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture
graft texture assessed as smooth, stippled, rolled, or other and as more firm, equally firm, less firm
Time frame: Day 14 post op
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation
tissue inflammation using a score of 0 (normal) to 4 (severe)
Time frame: Day 14 post op
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
graft failure by no evidence of keratinized tissue width
Time frame: Day 14 post op
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss
graft loss
Time frame: Day 14 post op
Graft Healing
graft healing is assessed by by multiple means
Time frame: 180 days
Clinical Attachment level
change in measured clinical attachment level from baseline to Day 180
Time frame: 180 days
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Change in Probing depths
change in measurement of probing depth from baseline to Day 180
Time frame: 180 days
Change in recession
change in measurement of recession from baseline to Day 180
Time frame: 180 days
Change in keratinized tissue
change in measurement of keratinized from baseline to Day 180
Time frame: 180 days
Change in gingival attachment
change in measurement of gingival attachment from baseline to Day 180
Time frame: 180 days
Healing as assessed by histological analysis
analysis by H\&E staining of biopsied tissue
Time frame: 90 days post op
Assessment of Infection through 180 days
infection assesse by redness, swelling, pus, fevers, chills
Time frame: 180 days
Occurrence of AEs/SAEs
Adverse events/Serious adverse events reported by site
Time frame: through 180 days
Subject Discomfort
Subject discomfort will be assessed using a single questionnaire containing questions on pain and the need for anti-inflammatory and/or pain meds.
Time frame: through 180 days