Pilot Study for Healing and Safety Outcomes in Gingival Recession

NCT04614350 | Completed Phase 4 FDA Drug

• 1 other identifier: MB2020-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, randomized, within subjects-controlled design

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Graft Healing

  180 days

• Clinical Attachment level

  180 days

• Change in Probing depths

  180 days

• Change in recession

  180 days

• Change in keratinized tissue

  180 days

Study Arms (2)

A-Active

EXPERIMENTAL

Markman Biologics microsurfaced ADM

Biological: Markman Biologics Microsurfaced ADM

B-Control

ACTIVE COMPARATOR

AlloDerm ADM

Biological: AlloDerm

Interventions

Markman Biologics Microsurfaced ADM BIOLOGICAL

an ADM which has been scored (microsurfaced)

A-Active

AlloDerm BIOLOGICAL

AlloDerm tissue matrix

B-Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGuire Institute: lead
• CellTherX: collaborator

Study Sites (1)

Perio Health Professionals

Houston, Texas, 77063, United States

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Rick Heard, DDS

  The McGuire Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, within subjects-controlled design

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: November 4, 2020
• Study Start: October 30, 2020
• Primary Completion: February 25, 2022
• Study Completion: June 30, 2022
• Last Updated: August 24, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)