A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Gingival Recession
- Sponsor
- McGuire Institute
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
Time Frame: 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
Time Frame: Day 14 post op
graft loss
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color
Time Frame: 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
Time Frame: 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
Time Frame: Day 14 post op
tissue inflammation using a score of 0 (normal) to 4 (severe)
Secondary Outcomes
- Assessment of Infection through 180 days(180 days)
- Subject Discomfort(through 180 days)
- Graft Healing(180 days)
- Change in recession(180 days)
- Change in keratinized tissue(180 days)
- Clinical Attachment level(180 days)
- Change in Probing depths(180 days)
- Change in gingival attachment(180 days)
- Healing as assessed by histological analysis(90 days post op)
- Occurrence of AEs/SAEs(through 180 days)