Back to resultsPilot Study for Healing and Safety Outcomes in Gingival Recession
Primary Purpose
Gingival Recession
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Markman Biologics Microsurfaced ADM
AlloDerm
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
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
- 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.
- Known allergy to Polysorbate 20
Sites / Locations
- Perio Health Professionals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A-Active
B-Control
Arm Description
Markman Biologics microsurfaced ADM
AlloDerm ADM
Outcomes
Primary Outcome Measures
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
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
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)
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
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
Secondary Outcome Measures
Graft Healing
graft healing is assessed by by multiple means
Clinical Attachment level
change in measured clinical attachment level from baseline to Day 180
Change in Probing depths
change in measurement of probing depth from baseline to Day 180
Change in recession
change in measurement of recession from baseline to Day 180
Change in keratinized tissue
change in measurement of keratinized from baseline to Day 180
Change in gingival attachment
change in measurement of gingival attachment from baseline to Day 180
Healing as assessed by histological analysis
analysis by H&E staining of biopsied tissue
Assessment of Infection through 180 days
infection assesse by redness, swelling, pus, fevers, chills
Occurrence of AEs/SAEs
Adverse events/Serious adverse events reported by site
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.
Full Information
NCT ID
NCT04614350
First Posted
September 2, 2020
Last Updated
August 22, 2022
Sponsor
McGuire Institute
Collaborators
Markman Biologics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04614350
Brief Title
Pilot Study for Healing and Safety Outcomes in Gingival Recession
Official Title
A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGuire Institute
Collaborators
Markman Biologics Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, within subjects-controlled design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-Active
Arm Type
Experimental
Arm Description
Markman Biologics microsurfaced ADM
Arm Title
B-Control
Arm Type
Active Comparator
Arm Description
AlloDerm ADM
Intervention Type
Biological
Intervention Name(s)
Markman Biologics Microsurfaced ADM
Intervention Description
an ADM which has been scored (microsurfaced)
Intervention Type
Biological
Intervention Name(s)
AlloDerm
Intervention Description
AlloDerm tissue matrix
Primary Outcome Measure Information:
Title
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by color
Description
tissue color
Time Frame
Day 14 post op
Title
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by texture
Description
graft texture assessed as smooth, stippled, rolled, or other and as more firm, equally firm, less firm
Time Frame
Day 14 post op
Title
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by inflammation
Description
tissue inflammation using a score of 0 (normal) to 4 (severe)
Time Frame
Day 14 post op
Title
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft failure
Description
graft failure by no evidence of keratinized tissue width
Time Frame
Day 14 post op
Title
To compare graft healing at post-op day 14 between Markman Biologics Microsurfaced ADM (Active) and AlloDerm ADM (Control) as assessed by graft loss
Description
graft loss
Time Frame
Day 14 post op
Secondary Outcome Measure Information:
Title
Graft Healing
Description
graft healing is assessed by by multiple means
Time Frame
180 days
Title
Clinical Attachment level
Description
change in measured clinical attachment level from baseline to Day 180
Time Frame
180 days
Title
Change in Probing depths
Description
change in measurement of probing depth from baseline to Day 180
Time Frame
180 days
Title
Change in recession
Description
change in measurement of recession from baseline to Day 180
Time Frame
180 days
Title
Change in keratinized tissue
Description
change in measurement of keratinized from baseline to Day 180
Time Frame
180 days
Title
Change in gingival attachment
Description
change in measurement of gingival attachment from baseline to Day 180
Time Frame
180 days
Title
Healing as assessed by histological analysis
Description
analysis by H&E staining of biopsied tissue
Time Frame
90 days post op
Title
Assessment of Infection through 180 days
Description
infection assesse by redness, swelling, pus, fevers, chills
Time Frame
180 days
Title
Occurrence of AEs/SAEs
Description
Adverse events/Serious adverse events reported by site
Time Frame
through 180 days
Title
Subject Discomfort
Description
Subject discomfort will be assessed using a single questionnaire containing questions on pain and the need for anti-inflammatory and/or pain meds.
Time Frame
through 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
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.
Known allergy to Polysorbate 20
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Heard, DDS
Organizational Affiliation
The McGuire Institute
Official's Role
Study Director
Facility Information:
Facility Name
Perio Health Professionals
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a single site study so data will not be other PIs to share the data with.
Learn more about this trial
Pilot Study for Healing and Safety Outcomes in Gingival Recession
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