Localized Gingival Recession Clinical Trial
Official title:
PriMatrix Dermal Repair Scaffold Utilization Intraorally
Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?
PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved
uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous
ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a
sheet-like matrix made up primarily of type I and type III collagen. An increased proportion
of type III collagen appears to play a key role in healing and regeneration.
The use of extracellular dermal matrices is a relatively young field, and the exact
mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this,
PriMatrix has demonstrated differences in manufacturing and molecular composition that make
it conducive to the harsh environments in which it has already been tested. Intraorally,
where there is a rich vascular bed, this material holds exceeding promise.
Utilizing this vascularity, autogenous free gingival grafts from the palate have already had
their efficacy proven as a method of augmenting the keratinized tissue.The need to increase
the keratinized tissue is based upon the postulation that less mobile, keratinized
epithelium is more resilient than the non-keratinized oral mucosa. This is especially
important in areas where recession and attachment loss has already occurred. Without having
keratinized gingiva apical to the recession area, it has been suggested that there is a
greater risk for more attachment loss to occur, thus reducing the support for the tooth. In
addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping
attachment" where a portion of the recession actually becomes covered as a result of
grafting.
While autogenous grafting is the gold standard in soft tissue augmentation, the amount of
tissue that can be taken from the palate is limited, making it difficult to treat patients
with generalized recession. Furthermore, a secondary surgical site increases the morbidity
associated with the procedure. The hypothesis of this study is that PriMatrix will be able
to provide similar results to an autogenous free gingival graft.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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| Completed |
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