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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)
University of Texas Health Science Center at San Antonio School of Dentistry
San Antonio, Texas, United States
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
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