Connective Tissue GraftPhase 4NCT07203326
Microderm for Root Coverage Procedures
A Phase 4 study testing Alloderm and MicroDerm in people with Connective Tissue Graft and Gum Recession, run by Ohio State University at 1 site in United States.
Trial summary
This randomized pilot study will compare Acellular Dermal Matrix (ADM) and a microsurfaced Acellular Dermal Matrix (mADM) for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue Graft, Gum Recession
- What is being tested?
- Alloderm and MicroDerm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 18+ years of age who require a tissue graft due to gum tissue recession.
Who cannot join
- Current smokers or users of nicotine replacement products
- Patients with diabetes (HbA1c > 5.6%)
- Pregnant or lactating women
- Surgical sites with previous soft tissue graft.
- Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
- Patients who are taking anticoagulant and antiplatelet medications.
- Patients with contraindications, e.g., allergy, for any of the medications used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen)
- Poor oral hygiene (PII >2)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Dentistry
Columbus, Ohio, 43210
About this study
Official title: Microsurfaced Acellular Dermal Matrix for Root Coverage Procedures
This randomized pilot study will compare Acellular Dermal Matrix (ADM) and a microsurfaced Acellular Dermal Matrix (mADM) for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort.
Read the detailed description
Advancements in Periodontal Surgery techniques and materials have continuously progressed to improve patient dental health. While the patient's own gum tissue from another site of the mouth as a graft [subepithelial connective tissue graft (SCTG)] remains the benchmark for tooth root coverage and increasing gum tissue, there are disadvantages to this surgical method. One disadvantage with this surgical method is the patient will have two surgical sites, one for the graft and one for the coverage of the exposed roots. Another disadvantage, there is limited tissue on the roof of the mouth for covering multiple exposed roots, which means multiple surgeries to cover all the exposed roots. For over 25 years, connective tissue graft surgery using Acellular Dermal Matrix (ADM) has served as an alternative to tissue grafts using the patient's own tissues. ADM is a processed material often used in gum surgery to avoid taking tissue from another part of the mouth) While ADM may not match SCTG for stability and gain in gum tissue, ADM remains a viable alternative to SCTG. Recently, a new ADM [microsurfaced Acellular Dermal Matrix (mADM)] has been developed to enhance healing and improve the surgical outcome. This randomized pilot study will compare ADM and mADM for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort.
- Conditions
- Connective Tissue Graft, Gum Recession
- Being tested
- Alloderm, MicroDerm
- Keywords
- Connective Tissue, Wound healing, Tooth root, Mouth, patient comfort, treatment outcome, acellular dermis matrix
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllodermBiological
Also called donated allograft human dermis, regenerative tissue matrix
Alloderm is a ready to use tissue graft, made from donated allograft human dermis, processed to remove cells while preserving biologic components and structure of the dermal matrix.
MicroDermBiological
Also called micro-surfaced acellular dermal matrix
MicroDerm is an acellular dermal matrix sourced from donated human tissue. Cytoplast™ MicroDerm is micro-surfaced.
| Study group | Role | What they receive |
|---|---|---|
| mADM | Experimental | The subjects in this arm will receive microderm as a soft tissue grafting material Receives: Biological: MicroDerm |
| ADM | Active comparator | The patients in this group will receive alloderm as a soft tissue grafting material Receives: Biological: Alloderm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical root coverage in percentage
To compare the wound healing of root coverage procedures, and the gain of root coverage using either a new microsurfaced Acellular Dermal Matrix(mADM) or Acellular Dermal Matrix (ADM).
Measured: From enrollment to up to one year after connective tissue graft surgery.
Secondary outcomes (1)
Comfort and aesthetic outcome as perceived by patient
By using a Visual Analog Scale (VAS) for Pain and a VAS for aesthetics, patients will note their comfort and appearance of the surgical site at different points after surgery. Scale for pain is from 0 (no pain) to 10 (worse pain imaginable). Scale for aesthetic is 0 (not meeting expectation/unnatural looking/no improvement) to 10 (perfect/natural/significant improvement).
Measured: From enrollment to up to one year after connective tissue graft surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start13 Feb 2025
- Primary completion31 Aug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective Tissue GraftStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203326
- Sponsor's protocol ID
- 2024H0313
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microsurfaced Acellular Dermal Matrix for Root Coverage Procedures
- ClinicalTrials.gov ID
- NCT07203326
- Acronym / sponsor ID
- 2024H0313
- Conditions
- Connective Tissue Graft, Gum Recession
- Keywords
- Connective Tissue, Wound healing, Tooth root, Mouth, patient comfort, treatment outcome, acellular dermis matrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
This randomized pilot study will compare Acellular Dermal Matrix (ADM) and a microsurfaced Acellular Dermal Matrix (mADM) for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort.
Detailed description
Advancements in Periodontal Surgery techniques and materials have continuously progressed to improve patient dental health. While the patient's own gum tissue from another site of the mouth as a graft [subepithelial connective tissue graft (SCTG)] remains the benchmark for tooth root coverage and increasing gum tissue, there are disadvantages to this surgical method. One disadvantage with this surgical method is the patient will have two surgical sites, one for the graft and one for the coverage of the exposed roots. Another disadvantage, there is limited tissue on the roof of the mouth for covering multiple exposed roots, which means multiple surgeries to cover all the exposed roots. For over 25 years, connective tissue graft surgery using Acellular Dermal Matrix (ADM) has served as an alternative to tissue grafts using the patient's own tissues. ADM is a processed material often used in gum surgery to avoid taking tissue from another part of the mouth) While ADM may not match SCTG for stability and gain in gum tissue, ADM remains a viable alternative to SCTG. Recently, a new ADM [microsurfaced Acellular Dermal Matrix (mADM)] has been developed to enhance healing and improve the surgical outcome. This randomized pilot study will compare ADM and mADM for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mADM | Experimental | Biological: MicroDermThe subjects in this arm will receive microderm as a soft tissue grafting material |
| ADM | Active comparator | Biological: AllodermThe patients in this group will receive alloderm as a soft tissue grafting material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants 18+ years of age who require a tissue graft due to gum tissue recession.
Key exclusion criteria (8 listed)
- Current smokers or users of nicotine replacement products
- Patients with diabetes (HbA1c > 5.6%)
- Pregnant or lactating women
- Surgical sites with previous soft tissue graft.
- Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
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 |
|---|---|---|
| AllodermAlso: donated allograft human dermis, regenerative tissue matrixAlloderm is a ready to use tissue graft, made from donated allograft human dermis, processed to remove cells while preserving biologic components and structure of the dermal matrix. | Biological | ADM |
| MicroDermAlso: micro-surfaced acellular dermal matrixMicroDerm is an acellular dermal matrix sourced from donated human tissue. Cytoplast™ MicroDerm is micro-surfaced. | Biological | mADM |
Primary outcome
Clinical root coverage in percentage
Time frame: From enrollment to up to one year after connective tissue graft surgery.
To compare the wound healing of root coverage procedures, and the gain of root coverage using either a new microsurfaced Acellular Dermal Matrix(mADM) or Acellular Dermal Matrix (ADM).
1 secondary outcome
Comfort and aesthetic outcome as perceived by patient
Time frame: From enrollment to up to one year after connective tissue graft surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alloderm and MicroDerm in people with Connective Tissue Graft and Gum Recession, run by Ohio State University 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 1 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical root coverage in percentage (time frame: From enrollment to up to one year after connective tissue graft surgery.). 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 26 Nov 2025.