Gingival RecessionPhase 4NCT04614350
Pilot Study for Healing and Safety Outcomes in Gingival Recession
A Phase 4 study testing Markman Biologics Microsurfaced ADM and AlloDerm in people with Gingival Recession, run by McGuire Institute at 1 site in United States.
Trial summary
Prospective, randomized, within subjects-controlled design Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Markman Biologics Microsurfaced ADM and AlloDerm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Gingival Recession
- Being tested
- Markman Biologics Microsurfaced ADM, AlloDerm
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Markman Biologics Microsurfaced ADMBiological
an ADM which has been scored (microsurfaced)
AlloDermBiological
AlloDerm tissue matrix
| Study group | Role | What they receive |
|---|---|---|
| A-Active | Experimental | Markman Biologics microsurfaced ADM Receives: Biological: Markman Biologics Microsurfaced ADM |
| B-Control | Active comparator | AlloDerm ADM Receives: Biological: AlloDerm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Day 14 post op
Secondary outcomes (10)
Graft Healing
graft healing is assessed by by multiple means
Measured: 180 days
Clinical Attachment level
change in measured clinical attachment level from baseline to Day 180
Measured: 180 days
Change in Probing depths
change in measurement of probing depth from baseline to Day 180
Measured: 180 days
Change in recession
change in measurement of recession from baseline to Day 180
Measured: 180 days
Change in keratinized tissue
change in measurement of keratinized from baseline to Day 180
Measured: 180 days
Change in gingival attachment
change in measurement of gingival attachment from baseline to Day 180
Measured: 180 days
Healing as assessed by histological analysis
analysis by H\&E staining of biopsied tissue
Measured: 90 days post op
Assessment of Infection through 180 days
infection assesse by redness, swelling, pus, fevers, chills
Measured: 180 days
Occurrence of AEs/SAEs
Adverse events/Serious adverse events reported by site
Measured: 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.
Measured: through 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start30 Oct 2020
- Primary completion25 Feb 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, within subjects-controlled design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGuire Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CellTherX
- Responsible party
- Sponsor
- Investigators
- Rick Heard, DDS, Study director, The McGuire Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614350
- Sponsor's protocol ID
- MB2020-01
- Status last verified
- Oct 2021
- First submitted
- 2 Sep 2020
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single site study so data will not be other PIs to share the data with.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study For Healing And Safety Outcomes In Creating Site Appropriate Keratinized Tissue Comparing Markman Biologics Microsurfaced ADM And AlloDerm ADM
- ClinicalTrials.gov ID
- NCT04614350
- Acronym / sponsor ID
- MB2020-01
- Conditions
- Gingival Recession
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McGuire InstituteIndustry (pharma, biotech, devices)
- Collaborators
- CellTherX
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, within subjects-controlled design
| Arm | Type | Receives |
|---|---|---|
| A-Active | Experimental | Biological: Markman Biologics Microsurfaced ADMMarkman Biologics microsurfaced ADM |
| B-Control | Active comparator | Biological: AlloDermAlloDerm ADM |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Markman Biologics Microsurfaced ADMan ADM which has been scored (microsurfaced) | Biological | A-Active |
| AlloDermAlloDerm tissue matrix | Biological | B-Control |
Primary outcome
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)
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
10 secondary outcomes
Graft Healing
Time frame: 180 days
Clinical Attachment level
Time frame: 180 days
Change in Probing depths
Time frame: 180 days
Change in recession
Time frame: 180 days
Change in keratinized tissue
Time frame: 180 days
Change in gingival attachment
Time frame: 180 days
Healing as assessed by histological analysis
Time frame: 90 days post op
Assessment of Infection through 180 days
Time frame: 180 days
Occurrence of AEs/SAEs
Time frame: through 180 days
Subject Discomfort
Time frame: through 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No. This is a single site study so data will not be other PIs to share the data with.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Heard, DDS study director
The McGuire Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Markman Biologics Microsurfaced ADM and AlloDerm in people with Gingival Recession, run by McGuire Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.