Clinical trial NCT04614350: Pilot Study for Healing and Safety Outcomes in Gingival Recession
Official title: A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: CellTherX
First posted: 2020-11-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, within subjects-controlled design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color
timeFrame: Day 14 post op
measure: To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture
timeFrame: Day 14 post op
measure: To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation
timeFrame: Day 14 post op
measure: To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
timeFrame: Day 14 post op
measure: To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss
timeFrame: Day 14 post op
Secondary outcomes:
measure: Graft Healing
timeFrame: 180 days
measure: Clinical Attachment level
timeFrame: 180 days
measure: Change in Probing depths
timeFrame: 180 days
measure: Change in recession
timeFrame: 180 days
measure: Change in keratinized tissue
timeFrame: 180 days
measure: Change in gingival attachment
timeFrame: 180 days
measure: Healing as assessed by histological analysis
timeFrame: 90 days post op
measure: Assessment of Infection through 180 days
timeFrame: 180 days
measure: Occurrence of AEs/SAEs
timeFrame: through 180 days
measure: Subject Discomfort
timeFrame: through 180 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
Study officials:
affiliation: The McGuire Institute
name: Rick Heard, DDS
role: STUDY_DIRECTOR
References: