Pilot Study for Healing and Safety Outcomes in Gingival Recession

McGuire Institute

Status and phase: Completed; Phase 4

Conditions: Gingival Recession

Treatments: Biological: Markman Biologics Microsurfaced ADM; Biological: AlloDerm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04614350

MB2020-01

Details and patient eligibility

About

Prospective, randomized, within subjects-controlled design

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

A-Active

Experimental group

Description:

Markman Biologics microsurfaced ADM

Treatment:

Biological: Markman Biologics Microsurfaced ADM

B-Control

Active Comparator group

Description:

AlloDerm ADM

Treatment:

Biological: AlloDerm