Gingival Recession
Conditions
Keywords
Gingival augmentation, Graft materials, Acellular dermal matrix (ADM), Subepithelial connective tissue graft (SCTG)
Brief 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.
Interventions
OTHERAllograft 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.
OTHERAllograft 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.
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between age 18 and 89 * Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth) * Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report. * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
Exclusion criteria
* Patients who disclose that they will not be able to cooperate with the follow-up schedule. * Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report) * Pregnant women or women intending to become pregnant during study period. * Smokers who smoke \> 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage root coverage | Baseline to 12 months | Measured as change in percentage root coverage |
| Keratinized tissue width | Baseline to 12 months | Measured as change in keratinized tissue width |
Countries
United States
Outcome results
None listed