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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gingival Recession

Intervention / Treatment
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* Other: Allograft Material ADM-S
* Other: Allograft Material ADM-D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a split-mouth design randomized, prospective trial designed to compare two standard of care techniques.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)<br>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. | Other: Allograft Material ADM-S<br>* 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.<br>* Other names: Acellular Dermal Matrix-superficial;|
| Active Comparator: Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)<br>The use of a deep cut ADM for root coverage gingival plastic procedures. | Other: Allograft Material ADM-D<br>* 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.<br>* Other names: Acellular Dermal Matrix-deep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingival augmentation, Graft materials, Acellular dermal matrix (ADM), Subepithelial connective tissue graft (SCTG)