Pilot Study for Healing and Safety Outcomes in Gingival Recession

A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM

Prospective, randomized, within subjects-controlled design

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Biological: Markman Biologics Microsurfaced ADM; Biological: AlloDerm

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77063
      • Perio Health Professionals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A-Active; Markman Biologics microsurfaced ADM	Biological: Markman Biologics Microsurfaced ADM; an ADM which has been scored (microsurfaced)
Active Comparator: B-Control; AlloDerm ADM	Biological: AlloDerm; AlloDerm tissue matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft Healing	graft healing is assessed by by multiple means	180 days
Clinical Attachment level	change in measured clinical attachment level from baseline to Day 180	180 days
Change in Probing depths	change in measurement of probing depth from baseline to Day 180	180 days
Change in recession	change in measurement of recession from baseline to Day 180	180 days
Change in keratinized tissue	change in measurement of keratinized from baseline to Day 180	180 days
Change in gingival attachment	change in measurement of gingival attachment from baseline to Day 180	180 days
Healing as assessed by histological analysis	analysis by H&E staining of biopsied tissue	90 days post op
Assessment of Infection through 180 days	infection assesse by redness, swelling, pus, fevers, chills	180 days
Occurrence of AEs/SAEs	Adverse events/Serious adverse events reported by site	through 180 days
Subject Discomfort	Subject discomfort will be assessed using a single questionnaire containing questions on pain and the need for anti-inflammatory and/or pain meds.	through 180 days

Collaborators and Investigators

• Sponsor: McGuire Institute
• Collaborators: Markman Biologics Corporation
• Investigators: Study Director: Rick Heard, DDS, The McGuire Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2020
• Primary Completion (Actual): February 25, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: MB2020-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is a single site study so data will not be other PIs to share the data with.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No