Gingival Recession Localized ModerateNCT07713199
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
A study testing Zderm in people with Gingival Recession Localized Moderate and Dental Implant, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Gingival Recession Localized Moderate, Dental Implant
- What is being tested?
- Zderm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 31 Jan 2029
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged 18 to 89
- One or more teeth/dental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT
- A FSTG is indicated and treatment planned to augment the KT. Coverage of exposed root surfaces is not indicated or intended. Patients needing root coverage surgical procedures re not eligible for enrollment (similar to our past studies, see references 11,12)
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.
- Patients who are nonsmokers or former smokers are eligible. Current smokers may also be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day).
Who cannot join
- Patients with a known allergy to collagen of animal origins.
- Patients who will not cooperate with the follow-up schedule.
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)
- Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
- Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
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- Patients with active or systemic infections other than periodontitis; a disease entity, condition or therapeutic regimen which decreases probability of soft tissue healing, e.g., poorly controlled diabetes, autoimmune diseases, long-term steroid therapy.
- Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)
- People who live more than 50 miles from the UTSA School of Dentistry are not eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Health Science Center at San Antonio School of Dentistry
San Antonio, Texas, 78229
Brian L Mealey, DDS, MS, 210-567-3318, mealey@uthscsa.edu
Angela Palaiologou-Gallis, DDS, 210-567-3589, palaiologouA@uthscsa.edu
About this study
Official title: Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)
Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. This study has 2 groups that differ only in the material that will be used at the graft site:
- Gum tissue taken from the patient's own palate (standard of care group)
- Commercially available collagen matrix derived from porcine (pig) Achilles tendon (FDA-approved for the surgery done in this study).
Read more
Both materials have been in use in dental practices for many years, but no studies have directly compared the outcomes between palatal tissue and the porcine collagen matrix we will use in this study.
Participants will be randomized into one of the 2 groups using sealed envelopes (the process is like flipping a coin). All the study visits will take place during regular dental appointments that would be scheduled even if not participating in this research.
Read the detailed description
The investigators are examining the amount of gingiva gained when using 2 different types of donor tissue to do the graft surgery: either gum tissue from the patient's palate (standard of care) or commercially available tissue called a "collagen matrix" that comes from an animal source (the Achilles tendon of pigs). Palatal tissue has been used for over 70 years for this purpose, while animal sources have been used for about 15 years. So far, no studies have been done to see if there are any differences in the amount of new gum tissue we see when we use the palatal tissue approach versus the animal tissue approach. The purpose of this study is to compare the 2 approaches during a period of 6 months after graft surgery to determine if the change in gingiva is similar or different between the 2 approaches.
Teeth are surrounded by soft tissue called gingiva (gums). Sometimes, the amount of gingiva is very small, which can lead to problems such as receding gums, pain on toothbrushing/flossing, and an increased risk for gum diseases. In such instances, dentists commonly perform surgery procedures to increase the amount of gum tissue around teeth or dental implants. "Gum grafting" involves taking a small piece of tissue from one location (called the donor site and donor tissue) and transplanting it to the area where the amount of gingiva is inadequate (called the recipient site because this location will receive the donor tissue).
- Being tested
- Zderm
- Keywords
- Tissue graft surgery, Receding gums, Keratinized tissue
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZdermDevice
The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)
| Study group | Role | What they receive |
|---|---|---|
| Test Group Porcine Collagen Matrix | Active comparator | The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. Receives: Device: Zderm |
| Control Group - Palatal Graft | No intervention | The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in width of Keratinized Tissue
The change in vertical distance from the gingival margin to the keratinized base of the grafted site measured on digital scans, and from the fixed reference point on the customized measurement stent to the keratinized base of the grafted site measured intra-orally.
Measured: Baseline to 6 months
Secondary outcomes (8)
Graft dimension width change
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft width (vertical dimension)
Measured: Baseline to 6 months
Graft Length Change
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft length (horizontal dimension).
Measured: Baseline to 6 months
Dimensional area change
Dimensional change of the grafted area during healing will be assessed by endpoints of graft width (vertical dimension), graft length (horizontal dimension) to measure graft area.
Measured: Baseline to 6 months
Length of surgery in minutes
The length of surgery in minutes will be assessed by use of a standard timer. The timer will start when the first incision is made. The timer will stop 3 minutes after the final suture is placed and pressure has been applied at the recipient surgery site.
Measured: Time to complete surgery (approximately 2-3 hours)
Numerical rating score for color match
A 21-point numerical rating scale (NRS-21) with which patients and clinicians can assess color match of the grafted area to the surrounding soft tissue. The NRS-21 scale allows scores ranging from 0 (worst color match) to 10 (best color match) in increments of 0.5.
Measured: One month to 6 months
San Antonio Texture index (SaTi)
A 4-point texture index score for clinicians to assess the tissue texture match of the grafted area to the surrounding soft tissue. The SATi is a four-point rating scale as follows:
- Major variation in texture compared to adjacent gingiva
- Moderate variation in texture compared to adjacent gingiva
- Minor variation in texture compared to adjacent gingiva
- Identical to adjacent gingiva= a bettter outcome
Measured: One month to six months
Pain Score on Numeric Rating Scale (NRS)
Pain associated with the surgery will be assessed by patients using NRS-21 that ranges from 0 to 10 in 0.5 increments, with 0 indicating no pain and 10 indicating intolerable pain. Patients will record NRS-21 scores on paper forms
Measured: 24 to 168 hours after surgery
Analgesic consumption
Participants will count and document number of analgesics (ibuprofen and acetaminophen) taken after surgery
Measured: 24 to 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession Localized ModerateStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial examining the results of soft tissue grafting to augment keratinized tissue (KT) using either 1) autogenous soft tissue from the patient's hard palate or 2) a xenograft collagen soft tissue matrix derived from porcine Achilles tendon (Zderm™).
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian L Mealey, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713199
- Sponsor's protocol ID
- STUDY00002814
- Status last verified
- Nov 2026
- First submitted
- 14 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: There is a plan to make Individual Participant Data available once it has been de-identified. Data will be shared as summary results on ClinicalTrials.gov and after publication in a peer review journal.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)
- ClinicalTrials.gov ID
- NCT07713199
- Acronym / sponsor ID
- STUDY00002814
- Keywords
- Tissue graft surgery, Receding gums, Keratinized tissue
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 20 Jul 2026 (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.
Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. This study has 2 groups that differ only in the material that will be used at the graft site:
- Gum tissue taken from the patient's own palate (standard of care group)
- Commercially available collagen matrix derived from porcine (pig) Achilles tendon (FDA-approved for the surgery done in this study).
Both materials have been in use in dental practices for many years, but no studies have directly compared the outcomes between palatal tissue and the porcine collagen matrix we will use in this study.
Participants will be randomized into one of the 2 groups using sealed envelopes (the process is like flipping a coin). All the study visits will take place during regular dental appointments that would be scheduled even if not participating in this research.
Detailed description
The investigators are examining the amount of gingiva gained when using 2 different types of donor tissue to do the graft surgery: either gum tissue from the patient's palate (standard of care) or commercially available tissue called a "collagen matrix" that comes from an animal source (the Achilles tendon of pigs). Palatal tissue has been used for over 70 years for this purpose, while animal sources have been used for about 15 years. So far, no studies have been done to see if there are any differences in the amount of new gum tissue we see when we use the palatal tissue approach versus the animal tissue approach. The purpose of this study is to compare the 2 approaches during a period of 6 months after graft surgery to determine if the change in gingiva is similar or different between the 2 approaches.
Teeth are surrounded by soft tissue called gingiva (gums). Sometimes, the amount of gingiva is very small, which can lead to problems such as receding gums, pain on toothbrushing/flossing, and an increased risk for gum diseases. In such instances, dentists commonly perform surgery procedures to increase the amount of gum tissue around teeth or dental implants. "Gum grafting" involves taking a small piece of tissue from one location (called the donor site and donor tissue) and transplanting it to the area where the amount of gingiva is inadequate (called the recipient site because this location will receive the donor tissue).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial examining the results of soft tissue grafting to augment keratinized tissue (KT) using either 1) autogenous soft tissue from the patient's hard palate or 2) a xenograft collagen soft tissue matrix derived from porcine Achilles tendon (Zderm™).
| Arm | Type | Receives |
|---|---|---|
| Test Group Porcine Collagen Matrix | Active comparator | Device: ZdermThe recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. |
| Control Group - Palatal Graft | No intervention | –The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patient aged 18 to 89
- One or more teeth/dental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT
- A FSTG is indicated and treatment planned to augment the KT. Coverage of exposed root surfaces is not indicated or intended. Patients needing root coverage surgical procedures re not eligible for enrollment (similar to our past studies, see references 11,12)
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.
- Patients who are nonsmokers or former smokers are eligible. Current smokers may also be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day).
Key exclusion criteria (9 listed)
- Patients with a known allergy to collagen of animal origins.
- Patients who will not cooperate with the follow-up schedule.
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)
- Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
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 |
|---|---|---|
| ZdermThe material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM) | Device | Test Group Porcine Collagen Matrix |
Primary outcome
Change in width of Keratinized Tissue
Time frame: Baseline to 6 months
The change in vertical distance from the gingival margin to the keratinized base of the grafted site measured on digital scans, and from the fixed reference point on the customized measurement stent to the keratinized base of the grafted site measured intra-orally.
8 secondary outcomes
Graft dimension width change
Time frame: Baseline to 6 months
Graft Length Change
Time frame: Baseline to 6 months
Dimensional area change
Time frame: Baseline to 6 months
Length of surgery in minutes
Time frame: Time to complete surgery (approximately 2-3 hours)
Numerical rating score for color match
Time frame: One month to 6 months
San Antonio Texture index (SaTi)
Time frame: One month to six months
Pain Score on Numeric Rating Scale (NRS)
Time frame: 24 to 168 hours after surgery
Analgesic consumption
Time frame: 24 to 168 hours
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make Individual Participant Data available once it has been de-identified. Data will be shared as summary results on ClinicalTrials.gov and after publication in a peer review journal.
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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.
Brian L Mealey, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zderm in people with Gingival Recession Localized Moderate and Dental Implant, run by The University of Texas Health Science Center at San Antonio 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 9 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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.
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?
Contact Brian L Mealey, DDS, MS (210-567-3589, mealey@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in width of Keratinized Tissue (time frame: Baseline to 6 months). 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 6 Nov 2026.