Pilot Study for Healing and Safety Outcomes in Gingival Recession

• Sponsor: McGuire Institute (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04614350
• Collaborator: Markman Biologics Corporation (Industry)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 20
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Prospective, randomized, within subjects-controlled design

Condition or Disease	Intervention/Treatment	Phase
Gingival Recession	Biological: Markman Biologics Microsurfaced ADM; Biological: AlloDerm	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized, within subjects-controlled designProspective, randomized, within subjects-controlled design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM
• Actual Study Start Date: Oct 30, 2020
• Actual Primary Completion Date: Feb 25, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color [Day 14 post op]

   tissue color

2. To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture [Day 14 post op]

   graft texture assessed as smooth, stippled, rolled, or other and as more firm, equally firm, less firm

3. To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation [Day 14 post op]

   tissue inflammation using a score of 0 (normal) to 4 (severe)

4. To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure [Day 14 post op]

   graft failure by no evidence of keratinized tissue width

5. To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss [Day 14 post op]

   graft loss

Secondary Outcome Measures

1. Graft Healing [180 days]

   graft healing is assessed by by multiple means

2. Clinical Attachment level [180 days]

   change in measured clinical attachment level from baseline to Day 180

3. Change in Probing depths [180 days]

   change in measurement of probing depth from baseline to Day 180

4. Change in recession [180 days]

   change in measurement of recession from baseline to Day 180

5. Change in keratinized tissue [180 days]

   change in measurement of keratinized from baseline to Day 180

6. Change in gingival attachment [180 days]

   change in measurement of gingival attachment from baseline to Day 180

7. Healing as assessed by histological analysis [90 days post op]

   analysis by H&E staining of biopsied tissue

8. Assessment of Infection through 180 days [180 days]

   infection assesse by redness, swelling, pus, fevers, chills

9. Occurrence of AEs/SAEs [through 180 days]

   Adverse events/Serious adverse events reported by site

10. Subject Discomfort [through 180 days]

    Subject discomfort will be assessed using a single questionnaire containing questions on pain and the need for anti-inflammatory and/or pain meds.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Perio Health Professionals	Houston	Texas	United States	77063

Sponsors and Collaborators

• McGuire Institute
• Markman Biologics Corporation

Investigators

• Study Director: Rick Heard, DDS, The McGuire Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: McGuire Institute
• ClinicalTrials.gov Identifier: NCT04614350
• Other Study ID Numbers: MB2020-01
• First Posted: Nov 4, 2020
• Last Update Posted: Aug 24, 2022
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Gingival Recession

Study Results

No Results Posted as of Aug 24, 2022