Gingival Recession
Conditions
Brief summary
Prospective, randomized, within subjects-controlled design
Detailed description
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.
Interventions
BIOLOGICALMarkman Biologics Microsurfaced ADM
an ADM which has been scored (microsurfaced)
BIOLOGICALAlloDerm
AlloDerm tissue matrix
Sponsors
CellTherX
McGuire Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, randomized, within subjects-controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed informed consent by patient or Legally Authorized Representative (LAR) 2. 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 3. Patients with good oral hygiene as indicated by presence of minimal plaque and absence of material alba and calculus. 4. ≥ 18 and ≤ 75 years of age 5. Sexually active subjects (both men and women) who agree to use acceptable contraceptive methods for the duration of the study.
Exclusion criteria
1. Vestibule depth \<7mm from the base of recession 2. Systemic condition, such as uncontrolled diabetes mellitus, HIV, cancer, or bone metabolic disease that could compromise wound healing 3. Treatment with systemic corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within 2 months of enrollment in the study 4. Acute infection lesions in intended grafting sites 5. Received intravenous or intramuscular bisphosphonates 6. Tobacco use within 3 months of enrollment or for the duration of the study 7. Only molar teeth suitable for soft tissue grafting (molars may be treated but not assigned as the study tooth) 8. Miller grade ≥2 mobility on grafting sites or adjacent teeth 9. Known hypersensitivity to bovine collagen or iodine (shellfish allergy) 10. Previous treatment with an advanced biologic at sites selected fro grafting or the adjacent teeth 11. Pregnant or nursing female subjects; women of child-bearing potential must have a negative urine pregnancy test. 12. 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. 13. 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. 14. Any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study 15. Known allergies to Cefoxitin, Gentamycin, Lincomycin, Polymyxin B, Vancomycin, or any antibiotic in these same classes. 16. Known allergy to Polysorbate 20
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color | Day 14 post op | tissue color |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture | Day 14 post op | graft texture assessed as smooth, stippled, rolled, or other and as more firm, equally firm, less firm |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation | Day 14 post op | tissue inflammation using a score of 0 (normal) to 4 (severe) |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure | Day 14 post op | graft failure by no evidence of keratinized tissue width |
| To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss | Day 14 post op | graft loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in gingival attachment | 180 days | change in measurement of gingival attachment from baseline to Day 180 |
| Healing as assessed by histological analysis | 90 days post op | analysis by H&E staining of biopsied tissue |
| Graft Healing | 180 days | graft healing is assessed by by multiple means |
| Occurrence of AEs/SAEs | through 180 days | Adverse events/Serious adverse events reported by site |
| Subject Discomfort | through 180 days | Subject discomfort will be assessed using a single questionnaire containing questions on pain and the need for anti-inflammatory and/or pain meds. |
| Assessment of Infection through 180 days | 180 days | infection assesse by redness, swelling, pus, fevers, chills |
| Clinical Attachment level | 180 days | change in measured clinical attachment level from baseline to Day 180 |
| Change in Probing depths | 180 days | change in measurement of probing depth from baseline to Day 180 |
| Change in recession | 180 days | change in measurement of recession from baseline to Day 180 |
| Change in keratinized tissue | 180 days | change in measurement of keratinized from baseline to Day 180 |
Countries
United States
Outcome results
None listed