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.
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 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)
Parallel
Zderm
DeviceThe 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.
Graft dimension width change
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft width (vertical dimension)
Graft Length Change
Dimensional change ("shrinkage") of the grafted area during healing will be assessed by measuring graft length (horizontal dimension).
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.
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.
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This trial is not recruiting at the moment. You can still explore other options:
