NCT05956496

Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices

Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.

Detailed description

Each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups, a commercially available allograft (ADM-D or ADM-S) will be used. Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes. Grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. When recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. This material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. The study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.

Conditions

• Gingival Recession

Interventions

Type	Name	Description
OTHER	Allograft Material ADM-S	A piece of the allograft material (ADM-D) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.
OTHER	Allograft Material ADM-D	A piece of the allograft material (ADM-S) will be hydrated per the manufacturers guidelines and adapted to the recipient area after reflection of a partial thickness flap. The flap will be coronally advanced to completely cover the graft material per standard care for this procedure.

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2023-07-21
• Last updated: 2024-04-11

Locations

1 site across 1 country: United States