Pilot Study for Healing and Safety Outcomes in Gingival Recession

Study Overview
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Brief Summary
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Prospective, randomized, within subjects-controlled design

Detailed Description
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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.

Official Title
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A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM

Conditions
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Gingival Recession

Intervention / Treatment
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* Biological: Markman Biologics Microsurfaced ADM
* Biological: AlloDerm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent by patient or Legally Authorized Representative (LAR) Patients with ≥2 non-adjacent teeth in the same jaw presenting with ≤ 1mm attached gingiva that requires soft tissue grafting without the need for root coverage Patients with good oral hygiene as indicated by presence of minimal plaque and absence of material alba and calculus. ≥ 18 and ≤ 75 years of age Sexually active subjects (both men and women) who agree to use acceptable contraceptive methods for the duration of the study. Exclusion Criteria: Vestibule depth <7mm from the base of recession Systemic condition, such as uncontrolled diabetes mellitus, HIV, cancer, or bone metabolic disease that could compromise wound healing Treatment with systemic corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within 2 months of enrollment in the study Acute infection lesions in intended grafting sites Received intravenous or intramuscular bisphosphonates Tobacco use within 3 months of enrollment or for the duration of the study Only molar teeth suitable for soft tissue grafting (molars may be treated but not assigned as the study tooth) Miller grade ≥2 mobility on grafting sites or adjacent teeth Known hypersensitivity to bovine collagen or iodine (shellfish allergy) Previous treatment with an advanced biologic at sites selected fro grafting or the adjacent teeth Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test. Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. Active alcohol or substance abuse (including marijuana, THC, CBD oils and products) in the opinion of the investigator that could impair the subject's participation in the study. Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study Known allergies to Cefoxitin, Gentamycin, Lincomycin, Polymyxin B, Vancomycin, or any antibiotic in these same classes. Known allergy to Polysorbate 20

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, within subjects-controlled design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-Active<br>Markman Biologics microsurfaced ADM | Biological: Markman Biologics Microsurfaced ADM<br>* an ADM which has been scored (microsurfaced)<br>|
| Active Comparator: B-Control<br>AlloDerm ADM | Biological: AlloDerm<br>* AlloDerm tissue matrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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) | 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 | 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 | Day 14 post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Healing | graft healing is assessed by by multiple means | 180 days | 
| Clinical Attachment level | change in measured clinical attachment level from baseline to Day 180 | 180 days | 
| Change in Probing depths | change in measurement of probing depth from baseline to Day 180 | 180 days | 
| Change in recession | change in measurement of recession from baseline to Day 180 | 180 days | 
| Change in keratinized tissue | change in measurement of keratinized from baseline to Day 180 | 180 days | 
| Change in gingival attachment | change in measurement of gingival attachment from baseline to Day 180 | 180 days | 
| Healing as assessed by histological analysis | analysis by H&E staining of biopsied tissue | 90 days post op | 
| Assessment of Infection through 180 days | infection assesse by redness, swelling, pus, fevers, chills | 180 days | 
| Occurrence of AEs/SAEs | Adverse events/Serious adverse events reported by site | 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. | through 180 days |