Clinical trial NCT05956496: Gingival Augmentation and Root Coverage With Superficial and Deep Cut Acellular Dermal Matrices
Official title: Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gingival Recession
Keywords: Gingival augmentation
Graft materials
Acellular dermal matrix (ADM)
Subepithelial connective tissue graft (SCTG)
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage root coverage
timeFrame: Baseline to 12 months
measure: Keratinized tissue width
timeFrame: Baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Angela Palaiologou-Gallis, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: