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The study team experienced an increased number of complications than expected
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S) | Placebo Comparator | A commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts. |
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| Test Group:Acellular Dermal Matrix - Deep cut (ADM-D) | Active Comparator | The use of a deep cut ADM for root coverage gingival plastic procedures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allograft Material ADM-S | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage root coverage | Measured as change in percentage root coverage | Baseline to 12 months |
| Keratinized tissue width | Measured as change in keratinized tissue width | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Palaiologou-Gallis, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
All collected de-identified Individual Participant data (IPD) that underlie results in a publication
When summary data are published or otherwise made available
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| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
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| Allograft Material ADM-D | Other | 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. |
|
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| D055093 |
| Periodontal Atrophy |