An interventional study of Zderm in Gingival Recession Localized Moderate and Dental Implant, sponsored by The University of Texas Health Science Center at San Antonio. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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:
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.
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).
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 68 is above the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Zderm
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
The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)
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.
Time frame: Baseline to 6 months
Graft dimension width change
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft width (vertical dimension)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: 1. Major variation in texture compared to adjacent gingiva 2. Moderate variation in texture compared to adjacent gingiva 3. Minor variation in texture compared to adjacent gingiva 4. Identical to adjacent gingiva= a bettter outcome
Time frame: 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
Time frame: 24 to 168 hours after surgery
Analgesic consumption
Participants will count and document number of analgesics (ibuprofen and acetaminophen) taken after surgery
Time frame: 24 to 168 hours
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After study end and data analysis is complete.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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